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Quality engineer jobs in Gainesville, FL

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  • Associate Quality Manager

    Summit Materials, Inc. 4.4company rating

    Quality engineer job in Newberry, FL

    The Associate Quality Manager is charged with assisting the Quality Control Manager in carrying out duties and responsibilities to ensure acceptable product quality at each phase of the manufacturing process. The Associate Quality Manager ensures a timely and orderly distribution of quality cement to our valued customer base. Managing timely receipt and quality of raw materials associated with challenges imposed by current environmental regulations is a necessity. Participates in the improvement of the Plant's technical capabilities. This position has a requirement of elevating the technical knowledge and practices of all facets of the operation. In this regard, the Associate Quality Manager will be fundamental to completing the technical triangle of quality-production-maintenance. In the absence of the QC Manager, the Coordinator assumes responsibility and authority for that position. Role & Responsibilities Responsibilities: * Supervise lab operators, lab facility and maintaining QC equipment * Perform all tasks safely and efficiently. Observes safety regulations and always established operational procedures. Promotes safety practices and efforts throughout the plant. * Maintains close contact with all phases of plant operation and informs the appropriate personnel of situations detrimental to product quality and production. * Initiate, direct and participate in studies designed to optimize cement manufacturing. * Monitors quality of incoming raw materials and fuels. * Balances rates of additives used to maintain quality and minimize cost. * Performs method development for new laboratory analysis. * Provide leadership and training for quality and production members to meet Customer expectations, plant objectives, DOT, AASHTO and ASTM Standards. * Identify and record quality problems; initiate, recommend or provide solutions through designated channels; and verify the implementation of solutions. * Maintain effective relations with customer services, sales and all plant departments. * Generate administrative paperwork associated with general laboratory and operations management. * Utilize statistical tools along with computer systems and automated analysis equipment to assist in process and product evaluation. * Initiate, participate in and direct audits as required. * Performing other duties as assigned #LI-SS Educational Requirements: * Bachelor's degree in chemical engineering or other related field with three (3) years' experience in a cement or other related industry OR an appropriate combination of education and experience. Experience/Skills Requirements: * Prefer minimum 3 years' experience in cement quality control or process engineering. * Prior experience in a cement-manufacturing environment with increasing responsibilities for quality product compliance. * Complete working knowledge of all equipment in laboratory * Ability to learn numerous software systems * Problem solving: Ability to conduct Root Cause Analysis for quality related issues * Requires good computer skills, must be able to effectively communicate, coordinate, interface, and correspond with customers and plant staff. Benefits * Recession Resistant Industry * Consistent work, with a work/life balance * Paid Holidays * Paid Time Off * 401(k) Plan w/ employer match contribution * Medical / Dental / Vision plan offered * Life Insurance - Company Paid * Short-term / Long-term Disability Insurance - Company Paid Get Hired What to Expect During our Hiring Process * Background Check * Motor Vehicle Record Check * 5-Panel Drug Screen * Fit for Duty Baseline Physical (if applicable) * A great team to support you throughout your career with Summit Materials companies! Build a Lasting Career with us. Begin Here. Go Anywhere. Apply now! Summit Materials consists of more than a dozen local companies that supply aggregates, cement, ready-mix concrete, asphalt paving, and construction services in the United States and western Canada. At Summit Materials, we support our teammates who lay the groundwork for our communities and live by our core values: Safety, Integrity, Sustainability, and Inclusivity. We're passionate about our teammates, our work, and our communities. Each of Summit's companies celebrates their individual legacies, but together - we are Summit Materials. At Summit Materials, we provide the foundation to connect our communities today and build a better tomorrow. We value all our communities - including our diverse internal community of teammates that make us stronger. No matter your race, ethnicity, gender, age, or anything that makes you who you are...you belong. Req #: 2013
    $61k-95k yearly est. 60d+ ago
  • QUALITY ASSURANCE MANAGER

    Morrison Healthcare 4.6company rating

    Quality engineer job in Gainesville, FL

    Job Description Morrison Healthcare is a leading national food and nutrition services company exclusively dedicated to serving more than 600 hospitals and healthcare systems. Morrison's hospital kitchens, restaurants, and cafés feature socially responsible practices and exceptional guest experiences. The company's comprehensive Mindful Choices wellness and sustainability platform includes the latest in healthful eating and an understanding of behavioral change in food consumption. Morrison's alignment with Partnership for a Healthier America's (PHA) Hospital Healthy Food Initiative positively impacts up to 41 million patients and 500 million hospital meals annually. Morrison has been named one of Modern Healthcare's "Top 100 Best Places to Work in Healthcare" for the past five years, and Training Magazine's Top 125 organizations for the past six consecutive years. The company is a division of Compass Group and has more than 1,200 registered dietitians, 300 executive chefs, and 17,000 professional food service team members. Job Summary The Quality Assurance Manager is responsible for development and maintenance of all QA programs, meeting USDA, FDA and customer requirements and ensuring the quality and safety of supplied goods. Must have strong knowledge in Preventive Controls for Human Food. A strong background in manufacturing, quality assurance and strong understand of FSMA is a must. Key Responsibilities: Contributes to development and execution of product food safety and quality programs to support the organization's goals of operational excellence, customer/client satisfaction, financial performance, market leadership, and preferred employer. Responsible for developing and on-going maintenance of the Food Safety Plan. Must be able to identify deficiencies and implement new strategies. Ensures all HACCP, GMP's, sanitation preventive controls, supply chain preventive controls and all other prerequisite food safety standards are met according to USDA, FDA, FSIS, FSMA and corporate requirements. Must have extensive knowledge of the facilities process flow and engage personnel in all areas of food safety and quality within the flow. Manages Allergen Preventive Controls Program ensuring accurate allergen labeling on finished food products and prevention of allergen cross contact. Manages the written recall program. Ensures complete traceability of incoming raw materials and finished product while managing lot code tracking. Ensures labeling programs is accurate in accordance with allergens, ingredients and nutritional information. Oversees all food safety audits conducted by government and third party agencies. Responds to customer safety and quality concerns as needed. Preferred Qualifications: At least 6 years of directly related experience required in Quality Assurance and Food Safety manufacturing role. Experienced in prepared foods manufacturing a plus. HACCP program development and FSMA is a must. HACCP certification, Preventive Controls for Human Food (PCQI) and GFSI auditor certification a must. Strong understanding of required third party audit and GFSI audit scheme programs and standards. Working knowledge of food processing and distribution regulations, i.e. FDA and USDA/FSIS, and industry practice. Experience developing and motivating personnel. Track record of food safety/QA success in any of the following focus areas a plus: meat, poultry, seafood, processed foods, distribution, proprietary/private-label product development and/or monitoring. B.S. degree in food technology, food science, or related curriculum and/or experience required. Ability to function effectively within a fast-paced, diverse and evolving corporate culture is necessary. Proficient in Microsoft Office applications and ability to learn various software and web-enabled programs. Must be a strong, persuasive communicator and coach, with the ability to relate to other professionals, peers, and field operators, both technical and non-technical. Strong data management, reporting, and technical writing skills. Apply to Morrison Healthcare today! Morrison Healthcare is a member of Compass Group USA Click here to Learn More about the Compass Story Associates at Morrison Healthcare are offered many fantastic benefits. Medical Dental Vision Life Insurance/ AD Disability Insurance Retirement Plan Flexible Time Off Paid Parental Leave Holiday Time Off (varies by site/state) Personal Leave Associate Shopping Program Health and Wellness Programs Discount Marketplace Identity Theft Protection Pet Insurance Commuter Benefits Employee Assistance Program Flexible Spending Accounts (FSAs) Associates may also be eligible for paid and/or unpaid time off benefits in accordance with applicable federal, state, and local laws. For positions in Washington State, Maryland, or to be performed Remotely, click here for paid time off benefits information. Compass Group is an equal opportunity employer. At Compass, we are committed to treating all Applicants and Associates fairly based on their abilities, achievements, and experience without regard to race, national origin, sex, age, disability, veteran status, sexual orientation, gender identity, or any other classification protected by law. Qualified candidates must be able to perform the essential functions of this position satisfactorily with or without a reasonable accommodation. Disclaimer: this job post is not necessarily an exhaustive list of all essential responsibilities, skills, tasks, or requirements associated with this position. While this is intended to be an accurate reflection of the position posted, the Company reserves the right to modify or change the essential functions of the job based on business necessity. We will consider for employment all qualified applicants, including those with a criminal history (including relevant driving history), in a manner consistent with all applicable federal, state, and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance, the San Francisco Fair Chance Ordinance, and the New York Fair Chance Act. We encourage applicants with a criminal history (and driving history) to apply. Applications are accepted on an ongoing basis. Morrison Healthcare maintains a drug-free workplace. Req ID: 1473708 Morrison Healthcare MICHAEL GREMBA [[req_classification]]
    $63k-93k yearly est. 1d ago
  • Quality Technician I

    Rev Group 4.4company rating

    Quality engineer job in Ocala, FL

    Apply now " Quality Technician I Company: REV Group, Inc. Work Hours: Mon-Thu 5:30a-4:00p, 30 min lunch Additional Locations: E-ONE manufactures custom and commercial fire trucks including pumpers and tankers, aerial ladders and platforms, rescues of all sizes, quick attack units, industrial trucks, and ARFF (aircraft rescue firefighting vehicles). Established in 1974, E-ONE has grown to become an industry leader in just a few decades, and today employs more than 1,000 people who manufacture over 400 fire trucks per year. Innovation has been the company's driving force and continues to be the impetus behind its pursuit of innovative technologies. The result is state-of-the-art fire rescue vehicles recognized for superior firefighting and rescue capabilities. E-ONE is part of the larger REV Group (NYSE: REVG), a leading manufacturer of specialty vehicles for the fire & emergency and recreation markets. REV Group's extensive vehicle line-up includes models such as ambulances, fire trucks, terminal trucks, RV's and much more. Our 5,000+ employees continuously demonstrate their commitment to building innovative and reliable vehicles that our customers can depend on whether for a family trip across the U.S. or when responding to an emergency. Rev Group is a veteran friendly employer and hires over 200 veterans and or those transferring out of the military each year. Job summary: The QRT (Quality Response Team) Technician inspects and prepares manufactured products for customer delivery/shipment, demonstrates the functionality, operation of apparatus for customers and dealers during inspection. The QRT Technician will perform postproduction work including clearing customer lists, PPAO/PPRW's and is responsible for ensuring that the accuracy of work completed meets customer requirements as well as Company requirements. The QRT Technician will perform the final process of clearing to ship the apparatuses. Responsibilities: * Perform QRT Process as defined by accounting and revenue recognition. * Act as advocate for our customers to ensure products conform to requirements. * Provide daily support to customers and the delivery center. * Perform pre-delivery activities, including multi-point inspection of apparatus, functionality checks of equipment and taking photos of all apparatus. * Disassemble components and diagnose problems to determine the extent of repairs and parts needed. * Pre-assemble position, mount, and install any range of required fixtures, hardware, and accessories on units to meet specifications. * Test installed items as required, determine causes of failures, and reassemble or refit subassemblies where components are found to be faulty or improperly installed. * Will be required to perform basic fabrication, cutting, material preparation, electrical work, paint touch-up, etc. * Document non-conformances and verify rework. * Requires active communication to production employees, Engineering, Quality and Sales on customer expectations, workmanship standards, quality requirements, etc. * Consistently exercises discretion and judgment in the performance of the work. * Support all ISO requirements, including calibration, control of documents, control of records, control of non-conforming production, etc. * Actively participate in the continuous improvement of products and processes to better serve the customer and improve operations. * Utilize problem solving skills from identification through root cause resolution. * Be present to support Customer Inspections when they are outside of the standard working hours. TOOLS AND EQUIPMENT USED: Tape measure, angle finder, air flow meter (CAFS), truck scales, Hand tools to include but not limited to power tools, saws, impact wrenches, grinders, belt sander, drill press, tape measure templates, multimeters, amp meters, portable jack systems for lifting trucks and heat gun. Overhead crane and fabrication equipment such as punch presses. Shears and Press Brakes. POSITION EXPECTATIONS: 1. SAFETY: Follow E-ONE General Health & Safety Rules, ensure safe operating conditions within area of responsibility, and notify coworkers and supervisors of hazardous acts and conditions. Proper use of PPE; use only defect-free equipment. Promote safety in the department. Use proper lifting techniques and overhead hoist when needed. Maintain clean and safe working environment in line with 5-S Philosophy. Participate in hazardous communication training and safety meetings. 2. QUALITY: Responsible for the quality of work. This requires defect-free work and understanding of the requirements of the company's quality system as it pertains to job duties and responsibilities. Must be able to check work to ensure conformance to process control instructions, specifications, and quality standards. Identify and segregate non-conforming products. Identify the need for and assist in initiating and implementing corrective and preventive actions when appropriate. 3. FLEXIBILITY: Able and willing to work in other areas as needed. Must be flexible in taking lunch and breaks when workflow requires. Willing to work additional hours, as necessary. 4. INITIATIVE: Actively participate in continuous improvement of products and processes to better serve customers and improve the overall profitability of E-ONE. Actively seek out work in other areas when the current assignment is complete. Make suggestions for improving product quality, processes, safety, and company profitability. 5. TEAMWORK: Positive working attitude toward other employees; be a team player. Work with others constructively and abide by company policies and procedures. Working together as a team for continuous improvement is vital to ensure the future of E-ONE and its employees. Teamwork will be required to be effective in daily production assignments as well as special improvement projects. 6. CAREER DEVELOPMENT: Attend and participate in a variety of meetings, training programs, and task force groups to integrate activities, communicate issues, obtain approvals, resolve problems, and maintain specific level of knowledge pertaining to changes to equipment or process, new developments, requirements, procedures, and policies. 7. LEADERSHIP: Lead the team, provide innovative thought leadership on strategies to grow market share, increase profitability, and meet long-term business goals. 8. ACTION-ORIENTED: Enjoy working hard; is action-oriented and energetic; not fearful of acting with a minimum of planning; seize more opportunities than others. 9. CONFLICT MANAGEMENT: Step up to conflicts, seeing them as opportunities; read situations quickly; good at focused listening; can hammer out tough agreements and settle disputes equitably; can find common ground and get cooperation. 10. DEALING WITH AMBIGUITY: Can effectively cope with change; can shift gears comfortably; can decide and act without having the total picture; isn't upset when things are up in the air; doesn't have to finish things before moving on; can comfortably handle risk and uncertainty. 11. DRIVE FOR RESULTS: Can be counted on to exceed goals successfully; is constantly and consistently one of the top performers; very bottom-line oriented; steadfastly pushes self and others for results. MINIMUM REQUIREMENTS: * Must be able to interface with customer, therefore must have positive people skills * Must possess advanced problem-solving skills from identification through root cause resolution * Minimum 5 years' experience in the operation or maintenance of Fire Apparatus, or equivalent. Must have thorough product knowledge, including functional operation. * Critical situations are common requiring superior judgment and consistency with company policy * Knowledge of computer skills (Baan, MS Access, Data Entry, Word, Excel, and Outlook) * Ability to effectively communicate and interact with customers and fellow employees, and ability to work in difficult situations. Proficient verbal and written communication skills. * Knowledge of FAA and NFPA * Required to obtain CDL license (Class A or B) (6-month max.) * Attention to detail * Strong Work Ethic * Some travel may be required PHYSICAL REQUIREMENTS: 1. Lift/Push/Pull- Exerting up to 40 pounds of force frequently, and/or up to 20 pounds of force constantly to move objects. 2. Climbing- Ascending or descending ladders, stairs, scaffolding, ramps, poles, and the like, using feet and legs and/or hands and arms. 3. Stooping- Bending body downward and forward by bending spine at the waist. 4. Kneeling- Bending legs at knee to come to a rest on knee or knees. 5. Crouching/Crawling/Reaching - Bending the body downward and forward by bending leg and spine. Moving about on hands and knees or hands and feet. Extending hand(s) and arm(s) in any direction. 6. Standing- Particularly for sustained periods of time. 7. Walking- Moving about on foot to accomplish tasks, particularly for long distances or moving from one work site to another. 8. The worker is required to have visual acuity to perform an activity such as operating machines such as lathes, drill presses, power saws and mills where the seeing job is at or within arm's reach; performing mechanical tasks of a non-repetitive nature such as carpenters, technicians, service people, plumbers, painters, mechanics, etc. The worker is required to have visual acuity to operate motor vehicles or heavy equipment 9. The worker is subject to hazards: Includes a variety of physical conditions, such as proximity to moving mechanical parts, moving vehicles, electrical current, working on scaffolding and high places, exposure to high heat or exposure to chemicals. REV Group is committed to a policy of equal employment opportunity. The Company conducts all employment practices without regard to race, sex, color, religion, national origin, age, disability, protected veteran's status, pregnancy, genetic information, sexual orientation, or any other basis prohibited by law. REV Group also undertakes affirmative action to assure equal employment opportunities for minorities and women, for persons with disabilities, and for protected veterans. NOTICE FOR CALIFORNIA RESIDENTS Effective January 1, 2020, pursuant to the California Consumer Privacy Act of 2018 (as amended, the "CCPA"), if you are a California resident, you may have certain additional rights. Please click on the link for a description of those rights and how California residents may exercise them.
    $39k-47k yearly est. 2d ago
  • Quality Technician

    Rti Surgical Inc. 4.5company rating

    Quality engineer job in Alachua, FL

    RTI Surgical is now Evergen! This rebrand reflects our strategic evolution as a leading CDMO in regenerative medicine and comes at the end of a significant year for the business, including the successful acquisitions of Cook Biotech in IN. and Collagen Solutions, MN. Our new brand identity emphasizes our unique positioning as the only CDMO offering a comprehensive portfolio of allograft and xenograft biomaterials at scale. About Evergen: Evergen (formally RTI Surgical) is a global industry-leading contract development and manufacturing organization (CDMO) in regenerative medicine. As the only regenerative medicine company that offers a differentiated portfolio of allograft and xenograft biomaterials at scale, Evergen is headquartered in Alachua, FL, and has manufacturing facilities in West Lafayette, IN., Eden Prairie and Glencoe, MN., Neunkirchen, DE., Glasgow, UK., and Marton, NZ. Read more about this change and Evergen's commitment to advancing regenerative medicine here: ************************ JOB RESPONSIBILITIES Provides quality support for the Quality Engineering functions such as manufacturing, sterility assurance, or supplier quality Performs investigations for product or supplier nonconformance and process noncompliance issues and documents exceptions appropriately in the Corrective Action / Preventative Action (CAPA) System Performs CAPA investigations using problem solving methodologies and a high attention to detail Participates in the review and disposition of non-conforming product or controlled process inputs including the Product Quality Review Board (PQRB), returns, and complaints Supports the review of validation documentation or new supplier qualification activities quickly and accurately in collaboration with engineers Performs audits of products or processes and documents the results appropriately Assists in the Change Management function including maintaining relevant work instructions, Standard Operations Procedures (SOPs), and other quality documentation Performs product acceptance testing, quality inspections, data entry, and data corrections quickly and efficiently May provide support for environmental monitoring investigations, documentation of quality inspections on controlled suppliers, or supports the Approved Supplier List monitoring activities Identifies and supports process improvement initiatives and implementation May support projects as a quality resource as assigned Other duties as assigned Education High School diploma or equivalent Experience 0 to 3 years of experience in quality assurance or quality control Certification N/A Skills Strong verbal and written communication Microsoft Office Suite, basic Excel Technical Writing Investigations SAFETY Physical Requirement Move or lift objects up to 25 pounds Frequent (>75%) stationary position (standing or sitting) while utilizing digital Frequent (>75%) fine manipulation using hands and fingers (typing, opening, writing, clicking, paper sorting, etc.) Working Environment Onsite: Office environment with assigned workstation #LI-Onsite
    $42k-53k yearly est. Auto-Apply 60d+ ago
  • Quality Assurance Manager

    IDEX 4.7company rating

    Quality engineer job in Ocala, FL

    If you're looking for a special place to build or grow your career, you've found it. Whether you're an experienced professional, a recent college graduate or somewhere in between, IDEX is a place where you can apply your existing skills and learn new ones in an environment where you can make an impact. With interesting opportunities in engineering, marketing, sales, supply chain, operations, HR, finance, and more across more than 40 diverse businesses (*********************************************************** around the globe, chances are, we have something special for you. Responsible for developing, deploying and leading the organization in a variety of quality processes and concepts that improve business performance and driving critical actions and results that align to the IDEX operating model and support the business goals. Develops, implements and coordinates the quality program to prevent or eliminate defects in new or existing products and systems by performing the following duties personally or through subordinates. **DUTIES AND RESPONSIBILITIES** + Administers and oversee all ISO 9001:2015 quality system requirements within the Ocala site. + Oversees the quality department processes and resources for Hale Products. + Ability to analyze and resolve process issues varying from basic to very complex. + Drive corrective actions, identifies trends, assists in problem resolution and ensures responsible parties meet their commitments. + Implements a successful Material Review process which includes dispositioning non-conforming components identifying components, identifying appropriate root cause and implementing corrective action on non-conforming to prevent recurrence. + Performs assessments and audits on processes and procedures to ensure compliance to specifications, engineering drawings, procedures as required by Hale's ISO commitments. + Interfaces with customers, suppliers and program personnel on quality related issues. + Apply statistical analysis using the DMAIC (Define, Measure, Analyze, Improve and Control) process to determine necessary course of action to improve or resolve issues. + Recommend and develop methods for improving utilization of equipment, personnel, material, and workspaces across the business. + Estimate financial impact of current and proposed change recommendations for management review, action, and controls. + Define and review product specifications necessary to establish quality and reliability objectives. + All other duties as assigned. **KNOWLEDGE, SKILLS AND REQUIRED ABILITIES** + Identifies, recruits, and develops the strongest talent. + Ability to influence and strategically partner with individuals of various educational and technical backgrounds, both inside and outside the organization. + Bias for action; drive to achieve results and goals in the short and long term. + Ability to define problems, collect data, establish facts and draw valid conclusions while fostering cross-functional/global problem solving and cooperation. + Ability to work independently and collaboratively with others toward mutual objectives. + Ability to communicate and enlist support for the vision of the organization. + The ability to adapt to work effectively in an environment of change, uncertainty, and ambiguity; can make pragmatic decisions in a timely fashion, especially when there is not a clear "right way." + Proficiency in Microsoft Office applications. + Strong leadership and influence skills, with and without direct authority. + Strong Project Management Skills + Excellent interpersonal, verbal and written skills. **EDUCATION AND EXPERIENCE** + BS in Manufacturing or Engineering, MBA preferred. + Minimum of 7-10 years quality management experience in a manufacturing environment + 5+ years experience with Supplier Approvals, Quality and Six Sigma tools (e.g. 8D's, PPAP's, VSM's, STD WORK, FMEA, GAGE R&R, DOE's as it relates to the DMAIC process). + Strong history of driving process improvements and implementing error-proofing strategies to eliminate defects proactively. **PHYSICAL DEMANDS** The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this position. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this position, the employee is regularly required to stand and walk. The employee is occasionally required to sit, climb or balance and stoop, kneel, crouch, or crawl. The employee must be able to lift and/or move up to 40 pounds or over 40 pounds with assistance. Specific vision abilities required by this job include close vision and ability to adjust focus. May be exposed to various workplace hazards, including chemicals, machinery, and noise. Proper use of personal protective equipment (PPE) is essential. Are you ready to join a different kind of company where our people, our culture, and our commitments are centered around providing trusted solutions that improve lives around the world? **IDEX is an Equal Opportunity Employer** . IDEX gives consideration for employment to qualified applicants without regard to race, color, religion, creed, genetic information, sex, sexual orientation, gender identity or expression, marital status, age, national origin, disability, protected veteran status, or any other consideration or protected category made unlawful by federal, state or local laws. **Attention Applicants:** If you are an individual with a disability and require a reasonable accommodation to complete any part of the application process, please let us know. Likewise, if you are limited in the ability to access or use this online application process and need an alternative method for applying, we will determine an alternate way for you to apply. Please contact our Talent Acquisition Team at ********************** for assistance with an accommodation. These contact tools may be used only by individuals with a disability for accommodation requests. Do not inquire as to the status of an application. **Job Family:** Engineering **Business Unit:** Hale
    $77k-97k yearly est. 60d+ ago
  • Sr. Quality Engineer

    Evergen

    Quality engineer job in Alachua, FL

    Job DescriptionLocation: Alachua, FL RTI Surgical is now Evergen! This rebranding reflects our strategic evolution as a leading CDMO in regenerative medicine and comes at the end of a significant year for the business, including the successful acquisitions of Cook Biotech in IN. and Collagen Solutions, MN. Our new brand identity emphasizes our unique positioning as the only CDMO offering a comprehensive portfolio of allograft and xenograft biomaterials at scale. Evergen is a global industry-leading contract development and manufacturing organization (CDMO) in regenerative medicine. As the only regenerative medicine company that offers a differentiated portfolio of allograft and xenograft biomaterials at scale, Evergen is headquartered in Alachua, FL, and has manufacturing facilities in West Lafayette, IN., Eden Prairie and Glencoe, MN., Neunkirchen, DE., Glasgow, UK., and Marton, NZ. Read more about this change and Evergen's commitment to advancing regenerative medicine here: ************************ RESPONSIBILITIES Serves as a lead core team member of cross functional project teams whose responsibilities include coordinating deliverables for the improvement of processes across the manufacturing facility Supervises the Quality Assurance Engineering team including performance management, corrective action, hiring and selection, and allocation of engineering support as it relates to quality assurance initiatives Reviews quality Key Performance Indicator (KPI) data and actions to ensure continuous improvement in collaboration with various operations value streams Reviews validations and risk management activities to support regulatory submissions, sustaining activities, and product launches are on time and have a high level of customer and patient focus Leads and conducts problem solving through change management, nonconformance workflows, and continuous improvement or new product development initiatives Reviews and edits nonconformance investigation and disposition phases for team members and assists in the preparation and presentation of materials for quality initiatives Other duties as assigned REQUIREMENTS Education Bachelor's degree in relevant technical discipline Experience 6+ years of relevant medical device, pharmaceutical, or other regulated industry experience. *Combination of advanced degree and experience may be considered. Certification AATB or CTBS Certification, preferred Lead Auditor Certification, preferred ASQ - CQE, CBA, or CQA, preferred Skills Excellent verbal and written communication Technical writing Problem solving methodologies Microsoft Office Suite Quality Management System software Investigations Statistical techniques Travel N/A SAFETY Physical Requirement Move or lift objects up to 25 pounds Frequent (>75%) stationary position (standing or sitting) while utilizing digital displays Frequent (>75%) fine manipulation using hands and fingers (typing, opening, writing, clicking, paper sorting, etc.) Working Environment Onsite: Office environment with assigned workstation Remote positions only: Home office environment with minimum distractions More about Evergen: Evergen provides customers across a diverse set of market segments with leading-edge expertise, scale, and flexibility across end-to-end services including design, development, regulatory support, verification and validation, manufacturing, and supply chain management. Evergen is rooted in a steadfast commitment to quality, integrity, and patient safety with a focus on five key values: Accountable: We own our actions and decisions. Agile: We embrace change to stay ahead of the curve and evolve to drive innovation and growth. Growth Mindset: We embrace challenges as opportunities for continuous learning. Customer-Centric: We prioritize customers at every touch point. Inclusive: We thrive on the richness of our diversity and ensure every voice is heard, respected, and celebrated. At Evergen, we are committed to fostering an inclusive workplace where we embrace the richness of our diversity and ensure that every voice is heard, respected, and celebrated. We believe that by embracing diversity and promoting inclusivity, we not only uphold our values but also strengthen our position as the CDMO of Choice in regenerative medicine solutions. We recognize that cultivating a growth mindset is essential to our success, and we are dedicated to continuous learning and improvement in our diversity, equity, and inclusion efforts. Through accountability and action, we strive to create an environment where individuals can thrive, innovate, and contribute their unique perspectives to drive our collective success. Montagu Private Equity (“Montagu”), a leading European private equity firm, acquired RTI in 2020 and has supported the transformation of the company to its next level of potential. #LI-Onsite
    $76k-101k yearly est. 26d ago
  • Medication Adherence Quality Coordinator

    Orlando Family Physicians 3.6company rating

    Quality engineer job in Lake City, FL

    This position is responsible to serve as primary liaison between Pharmacies and Innovacare Partners for the purposes of achieving and enhancing overall quality performance and metrics for InnovaCare Partner practices. The Medication Adherence Quality coordinator needs to have the ability to manage multiple tasks at once, prioritize information to be shared with the practice and collaborate across all staff in the practice. RESPONSIBILITIES The Medication Adherence Coordinator is responsible for navigation of specialty and comprehensive pharmacy therapies. Responsibilities include, but are not limited to, the following: knowledge of pharmacy prescription processing, strong communication, customer service, and motivational interview skills, with the ability to problem solve independently while working within a team structure. Ensure overall medication procurement and patient adherence management through proactive touch points telephonically include patients and pharmacies. Review and collate multiple sources of medical and pharmacy related information in assessing therapy appropriateness, effectiveness and patient adherence. Independence in performance of daily functions with the ability to effectively solicit collaboration with extended team members as appropriate. Participate in quality improvement initiatives and meetings as requested by management. Performs other duties and responsibilities as assigned. Continually educate self on latest information related to Stars Rating Program, Quality Measures, and thresholds as established by payers and other contracting entities. Supports special projects as assigned. Represents the company in special activities for providers and patients relations. EDUCATION AND EXPERIENCE High School Diploma or equivalent Pharmacy Technician, Medical Assistant, and/or LPN experience preferred Two years' experience in a health-care related field GENERAL KNOWLEDGE/SKILLS Ability to effectively communicate with patients regarding their medication therapies, adherence and overall drug management Excellent communication skills including proper phone etiquette Computer skills: proficient in Word, Excel, Power Point and Outlook. Ability to respond to a high volume of work and always maintain a polite and professional attitude. Able to function with frequent interruptions. Ability to prioritize workloads for maximum efficiency. Customer Service Skills: practicing, valuing and supporting service to both internal and external customers Time Management Skills: establishing priorities and accomplishing tasks in a timely manner Team Work: ability to work in a team environment to create solutions to problems Ability to work independently Strong analytical and problem-solving skills; ability analyze and interpret data Ability to effectively present and explain infomriaton and respond to questions Project management skills
    $60k-73k yearly est. Auto-Apply 60d+ ago
  • Quality Systems Associate

    Grifols Sa 4.2company rating

    Quality engineer job in Gainesville, FL

    Would you like to join an international team working to improve the future of healthcare? Do you want to enhance the lives of millions of people? Grifols is a global healthcare company that since 1909 has been working to improve the health and well-being of people around the world. We are leaders in plasma-derived medicines and transfusion medicine and develop, produce and market innovative medicines, solutions and services in more than 110 countries and regions. Quality Systems Associate Summary: Under the direct supervision of the Quality Systems Manager, perform quality assurance and Training functions to ensure compliance with internal and external regulations and protocol. Primary responsibilities for role (level-specific responsibilities should be included in the chart below): * Completes weekly review of equipment QC and maintenance records. * Documents, investigates, and performs root-cause analysis for deviations and customer complaints, specifically in how they related to product quality and/or donor safety. * Inspects and releases incoming supplies. Investigates and reports supplies have not met quality specifications and requirements prior to use. * Performs documentation review for unsuitable test results. * Assists the Quality Systems Manager to ensure that cGMP regulation, SOPs and regulatory requirements are followed. Duties include: * Under the direct supervision of the Quality Systems Manager, perform quality assurance and Training functions to ensure compliance with internal and external regulations and protocol. * Performs all product release activities. * Reviews lookback information and documentation. * Reviews waste shipment documentation. * Reviews unexpected plasmapheresis events including electronic donor chart and related documentation pertaining to exceptions occurring during the donation process. * Reviews electronic donor chart exceptions impacting donor eligibility/safety and/or product quality. * Reviews donor deferral notifications from competitor centers. * Reviews plasma processing documentation to ensure the proper freezing, storage and handling of product. Quality Systems Associate * Assist the Quality Systems Manager to ensure center training programs follow procedural requirements as defined in the donor center SOP and/or training programs documents. Duties include: * Creates, maintains, and audits training records and files to ensure compliance. * Performs employee training observations to ensure staff competency prior to releasing employees to work independently. * Conducts required training activities for Center Notifications, Corporate Directives, SOP changes, and initial SOP implementations. * On an occasional basis, when the Quality Systems Manager is absent, the Quality Systems Associate may be required to perform the following duties: * Reviews and approves of deferred donor reinstatement activities. * Assists with completion of the internal donor center audit. Summary: * Performs review of monthly trending report. * Performs review of donor adverse events reports and the applicable related documentation. * Conducts training to address donor center corrective and preventative measures. This job description is intended to present the general content and requirements for the performance of this job. The description is not to be construed as an exhaustive statement of duties, responsibilities, or requirements. Managers and supervisors may assign other duties as needed. Additional Responsibilities: Is certified and maintains certification as a Donor Center Technician. Knowledge, Skills, and Abilities: Developing command of interpersonal communication, organizational and problem-solving skills. Ability to understand FDA regulations. Strong integrity and commitment to quality and compliance. Good knowledge of mathematics. Legible handwriting. Proficiency with computers. Ability to work flexible scheduling to meet business needs. Performs basic document review and employee observations. Communicates openly with the CQM on issues noted during reviews. Ability to understand and follow SOP's and protocols. Ability to perform primary responsibilities of the Quality Associate role in a proficient manner. Has a basic understanding of cGMP and quality systems. Is able to spend hours sitting and reviewing documentation for accuracy. Demonstrates good organizational skills and attention to detail. Education: High school diploma or GED. Obtains state licensures or certifications if applicable. Experience: Typically requires no previous related experience. Occupational Demands Form # 70: Work is performed in a plasma center. Exposure to biological fluids with potential exposure to infectious organisms. Exposure to electrical office and laboratory equipment. Exposure to extreme cold below 32 degrees F while performing reviews in plasma freezers. Personal protective equipment required such as protective eyewear, garments, gloves and cold-gear. Work is performed mostly while sitting for up to 4 to 6 hours per day and standing from 2 to 4 hours per day. The position does require bending and twisting of neck up from 2 to 4 hours per day. Frequent hand movement of both hands with the ability to make fast, simple, movements of the fingers, hands, and wrists. Ability to make precise coordinated movements, of the fingers to grasp and manipulate objects. Frequent foot movement; may squat, crouch or sit on one's heels on rare occasion. Occasionally walks, bends and twists at waist. Light lifting of 15lbs. with a maximum lift of 50lbs. May reach below shoulder height. Hearing acuity essential. Color perception/discrimination, near vision and far vision correctable in one eye to 20/30 and to 20/100 in the other eye. Able to communicate information and ideas so others will understand; with the ability to listen to and understand information and ideas presented through spoken words and sentences. Works independently with little guidance or reliance on oral or written instructions. Performs a wide range of tasks as dictated by variable demands and changing conditions. Relates sensitive information to diverse groups. #biomatusa Third Party Agency and Recruiter Notice: Agencies that present a candidate to Grifols must have an active, nonexpired, Grifols Agency Master Services Agreement with the Grifols Talent Acquisition Department. Additionally, agencies may only submit candidates to positions that they have been engaged to work on by a Grifols Recruiter. All resumes must be sent to a Grifols Recruiter under these terms or they will be considered a Grifols candidate. Grifols provides equal employment opportunities to applicants and employees without regard to race; color; sex; gender identity; sexual orientation; religious practices and observances; national origin; pregnancy, childbirth, or related medical conditions; status as a protected veteran or spouse/family member of a protected veteran; or disability. We will consider for employment all qualified applicants in a manner consistent with the requirements of all applicable laws. Location: NORTH AMERICA : USA : FL-Gainesville:BTGNS - Gainesville FL-NW 13th St-BPC
    $43k-63k yearly est. 21d ago
  • QUALITY ASSURANCE MANAGER

    Compass Group USA Inc. 4.2company rating

    Quality engineer job in Gainesville, FL

    Morrison Healthcare Morrison Healthcare is a leading national food and nutrition services company exclusively dedicated to serving more than 600 hospitals and healthcare systems. Morrison's hospital kitchens, restaurants, and cafés feature socially responsible practices and exceptional guest experiences. The company's comprehensive Mindful Choices wellness and sustainability platform includes the latest in healthful eating and an understanding of behavioral change in food consumption. Morrison's alignment with Partnership for a Healthier America's (PHA) Hospital Healthy Food Initiative positively impacts up to 41 million patients and 500 million hospital meals annually. Morrison has been named one of Modern Healthcare's "Top 100 Best Places to Work in Healthcare" for the past five years, and Training Magazine's Top 125 organizations for the past six consecutive years. The company is a division of Compass Group and has more than 1,200 registered dietitians, 300 executive chefs, and 17,000 professional food service team members. Job Summary The Quality Assurance Manager is responsible for development and maintenance of all QA programs, meeting USDA, FDA and customer requirements and ensuring the quality and safety of supplied goods. Must have strong knowledge in Preventive Controls for Human Food. A strong background in manufacturing, quality assurance and strong understand of FSMA is a must. Key Responsibilities: * Contributes to development and execution of product food safety and quality programs to support the organization's goals of operational excellence, customer/client satisfaction, financial performance, market leadership, and preferred employer. * Responsible for developing and on-going maintenance of the Food Safety Plan. Must be able to identify deficiencies and implement new strategies. * Ensures all HACCP, GMP's, sanitation preventive controls, supply chain preventive controls and all other prerequisite food safety standards are met according to USDA, FDA, FSIS, FSMA and corporate requirements. * Must have extensive knowledge of the facilities process flow and engage personnel in all areas of food safety and quality within the flow. * Manages Allergen Preventive Controls Program ensuring accurate allergen labeling on finished food products and prevention of allergen cross contact. * Manages the written recall program. * Ensures complete traceability of incoming raw materials and finished product while managing lot code tracking. * Ensures labeling programs is accurate in accordance with allergens, ingredients and nutritional information. * Oversees all food safety audits conducted by government and third party agencies. * Responds to customer safety and quality concerns as needed. Preferred Qualifications: * At least 6 years of directly related experience required in Quality Assurance and Food Safety manufacturing role. * Experienced in prepared foods manufacturing a plus. * HACCP program development and FSMA is a must. * HACCP certification, Preventive Controls for Human Food (PCQI) and GFSI auditor certification a must. * Strong understanding of required third party audit and GFSI audit scheme programs and standards. * Working knowledge of food processing and distribution regulations, i.e. FDA and USDA/FSIS, and industry practice. * Experience developing and motivating personnel. * Track record of food safety/QA success in any of the following focus areas a plus: meat, poultry, seafood, processed foods, distribution, proprietary/private-label product development and/or monitoring. * B.S. degree in food technology, food science, or related curriculum and/or experience required. * Ability to function effectively within a fast-paced, diverse and evolving corporate culture is necessary. * Proficient in Microsoft Office applications and ability to learn various software and web-enabled programs. * Must be a strong, persuasive communicator and coach, with the ability to relate to other professionals, peers, and field operators, both technical and non-technical. * Strong data management, reporting, and technical writing skills. Apply to Morrison Healthcare today! Morrison Healthcare is a member of Compass Group USA Click here to Learn More about the Compass Story Associates at Morrison Healthcare are offered many fantastic benefits. * Medical * Dental * Vision * Life Insurance/ AD * Disability Insurance * Retirement Plan * Flexible Time Off * Paid Parental Leave * Holiday Time Off (varies by site/state) * Personal Leave * Associate Shopping Program * Health and Wellness Programs * Discount Marketplace * Identity Theft Protection * Pet Insurance * Commuter Benefits * Employee Assistance Program * Flexible Spending Accounts (FSAs) Associates may also be eligible for paid and/or unpaid time off benefits in accordance with applicable federal, state, and local laws. For positions in Washington State, Maryland, or to be performed Remotely, click here for paid time off benefits information. Compass Group is an equal opportunity employer. At Compass, we are committed to treating all Applicants and Associates fairly based on their abilities, achievements, and experience without regard to race, national origin, sex, age, disability, veteran status, sexual orientation, gender identity, or any other classification protected by law. Qualified candidates must be able to perform the essential functions of this position satisfactorily with or without a reasonable accommodation. Disclaimer: this job post is not necessarily an exhaustive list of all essential responsibilities, skills, tasks, or requirements associated with this position. While this is intended to be an accurate reflection of the position posted, the Company reserves the right to modify or change the essential functions of the job based on business necessity. We will consider for employment all qualified applicants, including those with a criminal history (including relevant driving history), in a manner consistent with all applicable federal, state, and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance, the San Francisco Fair Chance Ordinance, and the New York Fair Chance Act. We encourage applicants with a criminal history (and driving history) to apply. Applications are accepted on an ongoing basis. Morrison Healthcare maintains a drug-free workplace. Req ID: 1473708 Morrison Healthcare MICHAEL GREMBA [[req_classification]]
    $23k-38k yearly est. 49d ago
  • Digital Continuous Improvement Engineer

    Mars 4.7company rating

    Quality engineer job in Gainesville, FL

    In your role as the Factory Digital Lead (Digital Continuous Improvement Engineer), you will work as a Change Agent on optimizing performance and driving value leadership. The job is to be a “catalyst for change” and you will initiate and drive game-changing workstreams to optimize our cost-to-serve for our customers and support Mars to become a more efficient, agile and lean company. As a Factory Digital Lead, you will have accountability for the identification, implementation, and ongoing support of factory digital tools and automation work that support the overall effectiveness, efficiency, and continuous improvement of the factory floor. The role works closely with cross-functional partners to ensure the alignment of the tools to meet factory needs by functioning as the factory sponsor for regionally driven initiatives. This role also serves as the liaison between the factory and regional teams, with ownership of the factory digital and automation roadmap, which will be influenced and impacted by regional projects What are we looking for? Bachelor's in Engineering, Supply or a technical field. Master's degree preferred 2+ years of experience working in a technical manufacturing environment Knowledge of internal manufacturing and major business processes, FMCG would be a benefit Significant change management experience Project Management experience or leading continuous improvement initiatives Knowledge of industrial control systems networks including factory networks, distributed control systems, IoT, control devices, and hand-held electronic devices Strong experience with implementing and managing manufacturing and data analytics digital tools. (Such as Power BI, Power Automate, ZPI, digital forms, data lakes, SAP, etc.) Ability to work cross functionally with Senior Leaders and stakeholders Track record in leading step-change initiatives / Best practice roll out Eager to analyze and inspired by maximizing value What will be your key responsibilities? Own the vision and long-term strategy for Digital and Automation Masterplan at the site level, identify transformation opportunities and propose and shape business cases with clear value creation Identify, implement, deploy, and build associate capability of aligned digital tools to the factory floor devices Drive factory improvements through the implementation of digital tools and automation projects to meet critical needs of the factory, aid in reduction of losses and enhance compliance to critical internal standards (HSE, QFS, SIG, MSE, ex) Support and coach digital activities within the factory teams by providing tools, developing standards, and ensuring compliance to the usage of the tools. Manage multiple responsibilities including project execution, functional support, self-development, and concentrating on growing the role Ensure delivery of assigned objectives for scope, time, budget, and cash flow Build and maintain good relationship with key stakeholders and be able to influence in relative domains Work with the value stream, Reliability, and TPM Engineers to analyze and eliminate losses using digital or AI technology Key point of contact for the Global Digitalization program; support and lead the regional execution of relevant program's streams What can you expect from Mars? Work with diverse and talented Associates, all guided by the Five Principles. Join a purpose driven company, where we're striving to build the world we want tomorrow, today. Best-in-class learning and development support from day one, including access to our in-house Mars University. An industry competitive salary and benefits package, including company bonus. #LI-Onsite #MarsSnacking2025 #LI-GK24
    $66k-84k yearly est. Auto-Apply 29d ago
  • Medication Adherence Quality Coordinator

    Innovacare 3.7company rating

    Quality engineer job in Lake City, FL

    This position is responsible to serve as primary liaison between Pharmacies and Innovacare Partners for the purposes of achieving and enhancing overall quality performance and metrics for InnovaCare Partner practices. The Medication Adherence Quality coordinator needs to have the ability to manage multiple tasks at once, prioritize information to be shared with the practice and collaborate across all staff in the practice. RESPONSIBILITIES The Medication Adherence Coordinator is responsible for navigation of specialty and comprehensive pharmacy therapies. Responsibilities include, but are not limited to, the following: knowledge of pharmacy prescription processing, strong communication, customer service, and motivational interview skills, with the ability to problem solve independently while working within a team structure. Ensure overall medication procurement and patient adherence management through proactive touch points telephonically include patients and pharmacies. Review and collate multiple sources of medical and pharmacy related information in assessing therapy appropriateness, effectiveness and patient adherence. Independence in performance of daily functions with the ability to effectively solicit collaboration with extended team members as appropriate. Participate in quality improvement initiatives and meetings as requested by management. Performs other duties and responsibilities as assigned. Continually educate self on latest information related to Stars Rating Program, Quality Measures, and thresholds as established by payers and other contracting entities. Supports special projects as assigned. Represents the company in special activities for providers and patients relations. EDUCATION AND EXPERIENCE High School Diploma or equivalent Pharmacy Technician, Medical Assistant, and/or LPN experience preferred Two years' experience in a health-care related field GENERAL KNOWLEDGE/SKILLS Ability to effectively communicate with patients regarding their medication therapies, adherence and overall drug management Excellent communication skills including proper phone etiquette Computer skills: proficient in Word, Excel, Power Point and Outlook. Ability to respond to a high volume of work and always maintain a polite and professional attitude. Able to function with frequent interruptions. Ability to prioritize workloads for maximum efficiency. Customer Service Skills: practicing, valuing and supporting service to both internal and external customers Time Management Skills: establishing priorities and accomplishing tasks in a timely manner Team Work: ability to work in a team environment to create solutions to problems Ability to work independently Strong analytical and problem-solving skills; ability analyze and interpret data Ability to effectively present and explain infomriaton and respond to questions Project management skills
    $55k-82k yearly est. Auto-Apply 60d+ ago
  • (P) Industrial Engineer

    The Structures Company, LLC 4.1company rating

    Quality engineer job in Ocala, FL

    JOB TITLE: (P) Industrial Engineer PAY RATE: $62.26/hour We are a national aerospace and defense staffing agency seeking highly qualified candidates for a position with a top-tier client. Job Details: Job Type: Contract (6 months with potential for extension) Industry: Aerospace / Defense / Aviation Benefits: Medical, dental, and vision (Cigna) Perks: Bonus potential + Priority access via Tier 1 supplier Openings Nationwide: Thousands of opportunities across the U.S. Qualifying Questions: Are you a U.S. person as defined under ITAR regulations? Do you meet the educational and experience requirements for this role? Can you commute to the job location or relocate if necessary? Summary: Analyze and design workflows and operations to improve plant and production efficiency Optimize use of production facilities, equipment layouts, and personnel Develop methods to enhance productivity and reduce waste May establish safety measures and support training programs for operations Conduct cost, inventory, and production system studies Implement facility modifications and process improvements based on study findings May assist in facility planning and layout design with facilities engineers Requirements: Bachelor's degree in Industrial Engineering, Manufacturing Engineering, or related field required 4-6 years of experience with CCA/ECA's, SMT/PTH, Value Stream Mapping, 6S, and Waste Elimination 4-6 years of Industrial Engineering experience 4-6 years of Lean Manufacturing experience 4-6 years of AutoCAD experience 4-6 years conducting cost studies 4-6 years of experience in plant layout and process flow optimization Must be a U.S. Person (as defined by ITAR). About Us: The Structures Company is a premier national aerospace and defense staffing agency specializing in contract, contract-to-hire, and direct hire placements. We deliver expert workforce solutions across engineering, IT, production, maintenance, and support roles. As trusted partners to major aerospace OEMs and Tier 1 suppliers, we connect professionals with opportunities to grow and excel in the aviation and aerospace industries. Eligibility Requirements: Must be a U.S. Citizen, lawful permanent resident, or protected individual under 8 U.S.C. 1324b(a)(3) to comply with ITAR regulations. Keywords: aerospace, aviation, engineering, maintenance, aircraft design, defense Take your career to new heights-apply today!
    $62.3 hourly 60d+ ago
  • Plant Quality Technician

    Niagara Bottling 4.2company rating

    Quality engineer job in Middleburg, FL

    At Niagara, we're looking for Team Members who want to be part of achieving our mission to provide our customers the highest quality most affordable bottled water. Consider applying here, if you want to: * Work in an entrepreneurial and dynamic environment with a chance to make an impact. * Develop lasting relationships with great people. * Have the opportunity to build a satisfying career. We offer competitive compensation and benefits packages for our Team Members. Plant Quality Technician Responsible for executing corporate and plant specific Food Safety, Quality and Laboratory requirements. The QA Technician reports to QA Manager. In the absence of the Quality Assurance Technician, the QA Manager or designate will assume the job duties. Essential Functions * Ensure all parameters of food safety and quality are being adhered to and maintained throughout the facility. * Assist with batching chemicals/ingredients for production. * Calibrate lab and line equipment for accurate results. * Collect in-process and finished product samples. * Conduct standardized qualitative and quantitative testing to ensure it meets specifications. * Perform aseptic testing for microbial contamination. * Follow protocols for documenting testing results. * Recognize deficiencies and initiate proper follow-up. * Identify and isolate product that does not meet standards. * Aid in troubleshooting deficiencies and non-conformances. * Review food safety and quality records. * Actively participate in plant teams (HACCP, Safety, etc.) * Conduct other duties as assigned by management. * Please note this job description is not designed to contain a comprehensive list of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without prior notice. Qualifications * Minimum Qualifications: * 0 Years - Experience in Field or similar manufacturing environment * 0 Years - Experience in Position * 0 Years - Experience managing people/projects * experience may include a combination of work experience and education * Must read, write and communicate in English. * Must be able to work 12 hour shift (days or nights) on a rotating schedule * Must follow GMP Policy - wear company issued shirt, hat, safety glasses, earplugs and hairnet in production areas. * Able to lift up to 50 lbs. * Able to work under pressure in a very fast paced environment * Preferred Qualifications: * 2 Years- Experience in Field or similar manufacturing environment * 2 Years - Experience working in Position * 2 Years - Experience managing people/projects * experience may include a combination of work experience and education Competencies This position embodies the values of Niagara's LIFE competency model, focusing on the following key drivers of success: * Lead Like an Owner * Makes safety the number one priority * Keeps alert for safety issues and escalates immediately * Effectively prioritizes tasks based on department goals * Shows respect to others and confronts interpersonal issues directly * Prioritizes resolution of customer issues effectively * Responds promptly and honors commitments to internal and external customers * InnovACT * Makes recommendations to continuously improve policies, methods, procedures, and/or products * Demonstrates adaptability by reacting appropriately to unexpected changes in situations or circumstances * Increases performance through greater efficiency * Find a Way * Seeks to develop technical knowledge through learning from other experts * Understands interdepartmental impact of individual decisions and actions * Seeks solutions rather than placing blame * Empowered to be Great * Consistently looks for ways to improve one's self through growth and development opportunities * Communicates clearly and promptly up, down, and across * Communicates effectively to manage expectations Education * Minimum Required: * High School Diploma * Preferred: * Associate's Degree Certification/License: * Required: N/A * Preferred: HACCP Foreign Language * Required: Full Professional Proficiency * Preferred: None Required Benefits Our Total Rewards package is thoughtfully designed to support both you and your family: Regular full-time team members are offered a comprehensive benefits package, while part-time, intern, and seasonal team members are offered a limited benefits package. * Paid Time Off for holidays, sick time, and vacation time * Paid parental and caregiver leaves * Medical, including virtual care options * Dental * Vision * 401(k) with company match * Health Savings Account with company match * Flexible Spending Accounts * Expanded mental wellbeing benefits including free counseling sessions for all team members and household family members * Family Building Benefits including enhanced fertility benefits for IVF and fertility preservation plus adoption, surrogacy, and Doula reimbursements * Income protection including Life and AD&D, short and long-term disability, critical illness and an accident plan * Special discount programs including pet plans, pre-paid legal services, identity theft, car rental, airport parking, etc. * Tuition reimbursement, college savings plan and scholarship opportunities * And more! *********************************************** * *Los Angeles County applicants only Qualified applicants with arrest or conviction records will be considered for employment in accordance with the Los Angeles County Fair Chance Ordinance for Employers, the California Fair Chance Act, and any other applicable local and state laws. Any employment agency, person or entity that submits a résumé into this career site or to a hiring manager does so with the understanding that the applicant's résumé will become the property of Niagara Bottling, LLC. Niagara Bottling, LLC will have the right to hire that applicant at its discretion without any fee owed to the submitting employment agency, person or entity. Employment agencies that have fee agreements with Niagara Bottling, LLC and have been engaged on a search shall submit résumé to the designated Niagara Bottling, LLC recruiter or, upon authorization, submit résumé into this career site to be eligible for placement fees. Niagara Plant Name JACKSONVILLE
    $25k-37k yearly est. 2d ago
  • Quality Assurance Manager

    IDEX 4.7company rating

    Quality engineer job in Ocala, FL

    If you're looking for a special place to build or grow your career, you've found it. Whether you're an experienced professional, a recent college graduate or somewhere in between, IDEX is a place where you can apply your existing skills and learn new ones in an environment where you can make an impact. With interesting opportunities in engineering, marketing, sales, supply chain, operations, HR, finance, and more across more than 40 diverse businesses around the globe, chances are, we have something special for you. Responsible for developing, deploying and leading the organization in a variety of quality processes and concepts that improve business performance and driving critical actions and results that align to the IDEX operating model and support the business goals. Develops, implements and coordinates the quality program to prevent or eliminate defects in new or existing products and systems by performing the following duties personally or through subordinates. DUTIES AND RESPONSIBILITIES Administers and oversee all ISO 9001:2015 quality system requirements within the Ocala site. Oversees the quality department processes and resources for Hale Products. Ability to analyze and resolve process issues varying from basic to very complex. Drive corrective actions, identifies trends, assists in problem resolution and ensures responsible parties meet their commitments. Implements a successful Material Review process which includes dispositioning non-conforming components identifying components, identifying appropriate root cause and implementing corrective action on non-conforming to prevent recurrence. Performs assessments and audits on processes and procedures to ensure compliance to specifications, engineering drawings, procedures as required by Hale's ISO commitments. Interfaces with customers, suppliers and program personnel on quality related issues. Apply statistical analysis using the DMAIC (Define, Measure, Analyze, Improve and Control) process to determine necessary course of action to improve or resolve issues. Recommend and develop methods for improving utilization of equipment, personnel, material, and workspaces across the business. Estimate financial impact of current and proposed change recommendations for management review, action, and controls. Define and review product specifications necessary to establish quality and reliability objectives. All other duties as assigned. KNOWLEDGE, SKILLS AND REQUIRED ABILITIES Identifies, recruits, and develops the strongest talent. Ability to influence and strategically partner with individuals of various educational and technical backgrounds, both inside and outside the organization. Bias for action; drive to achieve results and goals in the short and long term. Ability to define problems, collect data, establish facts and draw valid conclusions while fostering cross-functional/global problem solving and cooperation. Ability to work independently and collaboratively with others toward mutual objectives. Ability to communicate and enlist support for the vision of the organization. The ability to adapt to work effectively in an environment of change, uncertainty, and ambiguity; can make pragmatic decisions in a timely fashion, especially when there is not a clear "right way." Proficiency in Microsoft Office applications. Strong leadership and influence skills, with and without direct authority. Strong Project Management Skills Excellent interpersonal, verbal and written skills. EDUCATION AND EXPERIENCE BS in Manufacturing or Engineering, MBA preferred. Minimum of 7-10 years quality management experience in a manufacturing environment 5+ years experience with Supplier Approvals, Quality and Six Sigma tools (e.g. 8D's, PPAP's, VSM's, STD WORK, FMEA, GAGE R&R, DOE's as it relates to the DMAIC process). Strong history of driving process improvements and implementing error-proofing strategies to eliminate defects proactively. PHYSICAL DEMANDS The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this position. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this position, the employee is regularly required to stand and walk. The employee is occasionally required to sit, climb or balance and stoop, kneel, crouch, or crawl. The employee must be able to lift and/or move up to 40 pounds or over 40 pounds with assistance. Specific vision abilities required by this job include close vision and ability to adjust focus. May be exposed to various workplace hazards, including chemicals, machinery, and noise. Proper use of personal protective equipment (PPE) is essential. Are you ready to join a different kind of company where our people, our culture, and our commitments are centered around providing trusted solutions that improve lives around the world? IDEX is an Equal Opportunity Employer. IDEX gives consideration for employment to qualified applicants without regard to race, color, religion, creed, genetic information, sex, sexual orientation, gender identity or expression, marital status, age, national origin, disability, protected veteran status, or any other consideration or protected category made unlawful by federal, state or local laws. Attention Applicants: If you are an individual with a disability and require a reasonable accommodation to complete any part of the application process, please let us know. Likewise, if you are limited in the ability to access or use this online application process and need an alternative method for applying, we will determine an alternate way for you to apply. Please contact our Talent Acquisition Team at ********************** for assistance with an accommodation. These contact tools may be used only by individuals with a disability for accommodation requests. Do not inquire as to the status of an application.
    $77k-97k yearly est. Auto-Apply 60d+ ago
  • QUALITY ASSURANCE MANAGER

    Compass Group, North America 4.2company rating

    Quality engineer job in Gainesville, FL

    Morrison Healthcare **Morrison Healthcare** is a leading national food and nutrition services company exclusively dedicated to serving more than 600 hospitals and healthcare systems. Morrison's hospital kitchens, restaurants, and cafés feature socially responsible practices and exceptional guest experiences. The company's comprehensive Mindful Choices wellness and sustainability platform includes the latest in healthful eating and an understanding of behavioral change in food consumption. Morrison's alignment with Partnership for a Healthier America's (PHA) Hospital Healthy Food Initiative positively impacts up to 41 million patients and 500 million hospital meals annually. Morrison has been named one of Modern Healthcare's "Top 100 Best Places to Work in Healthcare" for the past five years, and Training Magazine's Top 125 organizations for the past six consecutive years. The company is a division of Compass Group and has more than 1,200 registered dietitians, 300 executive chefs, and 17,000 professional food service team members. **Job Summary** **The Quality Assurance Manager** is responsible for development and maintenance of all QA programs, meeting USDA, FDA and customer requirements and ensuring the quality and safety of supplied goods. Must have strong knowledge in Preventive Controls for Human Food. A strong background in manufacturing, quality assurance and strong understand of FSMA is a must. **Key Responsibilities** : + Contributes to development and execution of product food safety and quality programs to support the organization's goals of operational excellence, customer/client satisfaction, financial performance, market leadership, and preferred employer. + Responsible for developing and on-going maintenance of the Food Safety Plan. Must be able to identify deficiencies and implement new strategies. + Ensures all HACCP, GMP's, sanitation preventive controls, supply chain preventive controls and all other prerequisite food safety standards are met according to USDA, FDA, FSIS, FSMA and corporate requirements. + Must have extensive knowledge of the facilities process flow and engage personnel in all areas of food safety and quality within the flow. + Manages Allergen Preventive Controls Program ensuring accurate allergen labeling on finished food products and prevention of allergen cross contact. + Manages the written recall program. + Ensures complete traceability of incoming raw materials and finished product while managing lot code tracking. + Ensures labeling programs is accurate in accordance with allergens, ingredients and nutritional information. + Oversees all food safety audits conducted by government and third party agencies. + Responds to customer safety and quality concerns as needed. **Preferred Qualifications:** + At least 6 years of directly related experience required in Quality Assurance and Food Safety manufacturing role. + Experienced in prepared foods manufacturing a plus. + HACCP program development and FSMA is a must. + HACCP certification, Preventive Controls for Human Food (PCQI) and GFSI auditor certification a must. + Strong understanding of required third party audit and GFSI audit scheme programs and standards. + Working knowledge of food processing and distribution regulations, i.e. FDA and USDA/FSIS, and industry practice. + Experience developing and motivating personnel. + Track record of food safety/QA success in any of the following focus areas a plus: meat, poultry, seafood, processed foods, distribution, proprietary/private-label product development and/or monitoring. + B.S. degree in food technology, food science, or related curriculum and/or experience required. + Ability to function effectively within a fast-paced, diverse and evolving corporate culture is necessary. + Proficient in Microsoft Office applications and ability to learn various software and web-enabled programs. + Must be a strong, persuasive communicator and coach, with the ability to relate to other professionals, peers, and field operators, both technical and non-technical. + Strong data management, reporting, and technical writing skills. **Apply to Morrison Healthcare today!** _Morrison Healthcare is a member of Compass Group USA_ Click here to Learn More about the Compass Story (************************************** **Associates at Morrison Healthcare are offered many fantastic benefits.** + Medical + Dental + Vision + Life Insurance/ AD + Disability Insurance + Retirement Plan + Flexible Time Off + Paid Parental Leave + Holiday Time Off (varies by site/state) + Personal Leave + Associate Shopping Program + Health and Wellness Programs + Discount Marketplace + Identity Theft Protection + Pet Insurance + Commuter Benefits + Employee Assistance Program + Flexible Spending Accounts (FSAs) Associates may also be eligible for paid and/or unpaid time off benefits in accordance with applicable federal, state, and local laws. For positions in Washington State, Maryland, or to be performed Remotely, click here (****************************************************************************************************** for paid time off benefits information. **Compass Group is an equal opportunity employer. At Compass, we are committed to treating all Applicants and Associates fairly based on their abilities, achievements, and experience without regard to race, national origin, sex, age, disability, veteran status, sexual orientation, gender identity, or any other classification protected by law.** **Qualified candidates must be able to perform the essential functions of this position satisfactorily with or without a reasonable accommodation. Disclaimer: this job post is not necessarily an exhaustive list of all essential responsibilities, skills, tasks, or requirements associated with this position. While this is intended to be an accurate reflection of the position posted, the Company reserves the right to modify or change the essential functions of the job based on business necessity. We will consider for employment all qualified applicants, including those with a criminal history (including relevant driving history), in a manner consistent with all applicable federal, state, and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance, the San Francisco Fair Chance Ordinance, and the New York Fair Chance Act. We encourage applicants with a criminal history (and driving history) to apply.** **Applications are accepted on an ongoing basis.** **Morrison Healthcare maintains a drug-free workplace.** **Req ID:** 1473708 Morrison Healthcare MICHAEL GREMBA [[req_classification]]
    $23k-38k yearly est. 49d ago
  • IT Validation Engineer 1

    Rti Surgical Inc. 4.5company rating

    Quality engineer job in Alachua, FL

    RTI Surgical is now Evergen! This rebranding reflects our strategic evolution as a leading CDMO in regenerative medicine and comes at the end of a significant year for the business, including the successful acquisitions of Cook Biotech in IN. and Collagen Solutions, MN. Our new brand identity emphasizes our unique positioning as the only CDMO offering a comprehensive portfolio of allograft and xenograft biomaterials at scale. Evergen is a global industry-leading contract development and manufacturing organization (CDMO) in regenerative medicine. As the only regenerative medicine company that offers a differentiated portfolio of allograft and xenograft biomaterials at scale, Evergen is headquartered in Alachua, FL, and has manufacturing facilities in West Lafayette, IN., Eden Prairie and Glencoe, MN., Neunkirchen, DE., Glasgow, UK., and Marton, NZ. Read more about this change and Evergen's commitment to advancing regenerative medicine here: ************************ ; RESPONSIBILITIES Identify and qualify all computer systems which impact cGMP operations using a risk-based methodology Develop 21 CFR Part 11 computer system validation plans, qualification test protocols, traceability matrices, reports, IQ/OQ/PQ protocols, and all other documents within the scope of the validation plan Develop and maintain test plans, test scripts, user acceptance tests, and manage the execution of test plans Maintain and improve software validation and testing processes Work with software developers and testers to write specification documents according to established procedures Design and set up product labels using Loftware, SQL, and ZPL based on requirements from stakeholders Conduct validation and testing for product labels Set up meetings with key project stakeholders to gather requirements for software development projects Conduct analysis of business processes and functional requirements Apply technical and business knowledge to analyze stakeholder requirements and document as part of the software validation process Work with cross-functional leadership and functional teams to understand business requirements and investigate issues using root cause analysis for NCs, CAPAs, and projects Other duties as assigned REQUIREMENTS: Education Associate degree in computer science, information technology, or related field Experience 0-3 years of relevant experience in a regulated industry in testing, quality assurance, or validation documentation development using risk-based methodology Additional experience may be substituted for education requirements Experience with Manufacturing, ERP, quality systems, database systems, SQL is preferred Experience in Agile software development lifecycle processes is preferred Experience in regulated environments, such as FDA or AATB, is preferred Skills Excellent verbal and written communication Computer Systems Validation (CSV) methodologies using a risk-based approach Experience with Octane for manual and automated testing Advance SQL query writing Excellent problem-solving skills with ability to work in collaborative and independent working situations and environments with minimal supervision Must work and interact effectively and professionally with and for others throughout various levels of the global organization Ability to simultaneously manage multiple projects Ability to remain calm and receptive in fast-paced situations Travel Occasional travel for training and meetings as needed. Safety: Physical Requirement Move or lift objects up to 25 pounds Frequent (>75%) stationary position (standing or sitting) while utilizing digital displays Frequent (>75% fine manipulation using hands and fingers (typing, opening, writing, clicking, paper sorting, etc.) Working Environment Onsite: Office environment with assigned workstation More about Evergen: Evergen provides customers across a diverse set of market segments with leading-edge expertise, scale, and flexibility across end-to-end services including design, development, regulatory support, verification and validation, manufacturing, and supply chain management. Evergen is rooted in a steadfast commitment to quality, integrity, and patient safety with a focus on five key values: Accountable: We own our actions and decisions. Agile: We embrace change to stay ahead of the curve and evolve to drive innovation and growth. Growth Mindset: We embrace challenges as opportunities for continuous learning. Customer-Centric: We prioritize customers at every touch point. Inclusive: We thrive on the richness of our diversity and ensure every voice is heard, respected, and celebrated. At Evergen, we are committed to fostering an inclusive workplace where we embrace the richness of our diversity and ensure that every voice is heard, respected, and celebrated. We believe that by embracing diversity and promoting inclusivity, we not only uphold our values but also strengthen our position as the CDMO of Choice in regenerative medicine solutions. We recognize that cultivating a growth mindset is essential to our success, and we are dedicated to continuous learning and improvement in our diversity, equity, and inclusion efforts. Through accountability and action, we strive to create an environment where individuals can thrive, innovate, and contribute their unique perspectives to drive our collective success. Montagu Private Equity (“Montagu”), a leading European private equity firm, acquired RTI in 2020 and has supported the transformation of the company to its next level of potential. #LI-onsite
    $67k-87k yearly est. Auto-Apply 43d ago
  • IT Validation Engineer 1

    Evergen

    Quality engineer job in Alachua, FL

    Job Description RTI Surgical is now Evergen! This rebranding reflects our strategic evolution as a leading CDMO in regenerative medicine and comes at the end of a significant year for the business, including the successful acquisitions of Cook Biotech in IN. and Collagen Solutions, MN. Our new brand identity emphasizes our unique positioning as the only CDMO offering a comprehensive portfolio of allograft and xenograft biomaterials at scale. Evergen is a global industry-leading contract development and manufacturing organization (CDMO) in regenerative medicine. As the only regenerative medicine company that offers a differentiated portfolio of allograft and xenograft biomaterials at scale, Evergen is headquartered in Alachua, FL, and has manufacturing facilities in West Lafayette, IN., Eden Prairie and Glencoe, MN., Neunkirchen, DE., Glasgow, UK., and Marton, NZ. Read more about this change and Evergen's commitment to advancing regenerative medicine here: ************************ RESPONSIBILITIES Identify and qualify all computer systems which impact cGMP operations using a risk-based methodology Develop 21 CFR Part 11 computer system validation plans, qualification test protocols, traceability matrices, reports, IQ/OQ/PQ protocols, and all other documents within the scope of the validation plan Develop and maintain test plans, test scripts, user acceptance tests, and manage the execution of test plans Maintain and improve software validation and testing processes Work with software developers and testers to write specification documents according to established procedures Design and set up product labels using Loftware, SQL, and ZPL based on requirements from stakeholders Conduct validation and testing for product labels Set up meetings with key project stakeholders to gather requirements for software development projects Conduct analysis of business processes and functional requirements Apply technical and business knowledge to analyze stakeholder requirements and document as part of the software validation process Work with cross-functional leadership and functional teams to understand business requirements and investigate issues using root cause analysis for NCs, CAPAs, and projects Other duties as assigned REQUIREMENTS: Education Associate degree in computer science, information technology, or related field Experience 0-3 years of relevant experience in a regulated industry in testing, quality assurance, or validation documentation development using risk-based methodology Additional experience may be substituted for education requirements Experience with Manufacturing, ERP, quality systems, database systems, SQL is preferred Experience in Agile software development lifecycle processes is preferred Experience in regulated environments, such as FDA or AATB, is preferred Skills Excellent verbal and written communication Computer Systems Validation (CSV) methodologies using a risk-based approach Experience with Octane for manual and automated testing Advance SQL query writing Excellent problem-solving skills with ability to work in collaborative and independent working situations and environments with minimal supervision Must work and interact effectively and professionally with and for others throughout various levels of the global organization Ability to simultaneously manage multiple projects Ability to remain calm and receptive in fast-paced situations Travel Occasional travel for training and meetings as needed. Safety: Physical Requirement Move or lift objects up to 25 pounds Frequent (>75%) stationary position (standing or sitting) while utilizing digital displays Frequent (>75% fine manipulation using hands and fingers (typing, opening, writing, clicking, paper sorting, etc.) Working Environment Onsite: Office environment with assigned workstation More about Evergen: Evergen provides customers across a diverse set of market segments with leading-edge expertise, scale, and flexibility across end-to-end services including design, development, regulatory support, verification and validation, manufacturing, and supply chain management. Evergen is rooted in a steadfast commitment to quality, integrity, and patient safety with a focus on five key values: Accountable: We own our actions and decisions. Agile: We embrace change to stay ahead of the curve and evolve to drive innovation and growth. Growth Mindset: We embrace challenges as opportunities for continuous learning. Customer-Centric: We prioritize customers at every touch point. Inclusive: We thrive on the richness of our diversity and ensure every voice is heard, respected, and celebrated. At Evergen, we are committed to fostering an inclusive workplace where we embrace the richness of our diversity and ensure that every voice is heard, respected, and celebrated. We believe that by embracing diversity and promoting inclusivity, we not only uphold our values but also strengthen our position as the CDMO of Choice in regenerative medicine solutions. We recognize that cultivating a growth mindset is essential to our success, and we are dedicated to continuous learning and improvement in our diversity, equity, and inclusion efforts. Through accountability and action, we strive to create an environment where individuals can thrive, innovate, and contribute their unique perspectives to drive our collective success. Montagu Private Equity (“Montagu”), a leading European private equity firm, acquired RTI in 2020 and has supported the transformation of the company to its next level of potential. #LI-onsite
    $62k-84k yearly est. 15d ago
  • Process Engineer

    Summit Materials, Inc. 4.4company rating

    Quality engineer job in Newberry, FL

    Are you passionate about process optimization and industrial efficiency? Do you enjoy solving complex challenges that drive measurable results? Join our team as a Process Engineer and become a key player in shaping the performance of our state-of-the-art cement plant. This is your chance to make a real impact in a vital industry-improving systems, reducing costs, and contributing to a more sustainable future. Role & Responsibilities Responsibilities: * Own and monitor the different production areas' daily performance metrics - drive productivity and ensure continuous alignment with operational goals. * Identify and implement process improvements that reduce variable costs and increase energy efficiency. * Lead or support continuous improvement initiatives with a data-driven approach (mass & heat balances, flow measurements, process audits, etc.). * Conduct mini-audits across sub-systems (e.g., compressed air, false air) to uncover hidden inefficiencies. * Support the planning and execution of plant performance strategies alongside the Production Manager and process team. * Collaborate on short-term development projects, evaluating the process viability of new investments, methods, and technologies. * Utilize and optimize expert control systems to fine-tune performance and stability. * Track and report the effectiveness of implemented changes - especially new materials, equipment, or control strategies. * Take ownership of other process-related challenges as assigned. Educational Requirements: * You're a natural problem-solver with strong analytical skills and attention to detail. * You enjoy digging into data, observing processes, and asking "how can we make this better?" * You're comfortable balancing on-the-ground realities with long-term strategy. * You communicate clearly, work well in teams, and thrive in a dynamic industrial environment. Benefits * Recession Resistant Industry * Consistent work, with a work/life balance * Paid Holidays * Paid Time Off * 401(k) Plan w/ employer match contribution * Medical / Dental / Vision plan offered * Life Insurance - Company Paid * Short-term / Long-term Disability Insurance - Company Paid Get Hired What to Expect During our Hiring Process * Background Check * Motor Vehicle Record Check * 5-Panel Drug Screen * Fit for Duty Baseline Physical (if applicable) * A great team to support you throughout your career with Summit Materials companies! Build a Lasting Career with us. Begin Here. Go Anywhere. Apply now! Summit Materials consists of more than a dozen local companies that supply aggregates, cement, ready-mix concrete, asphalt paving, and construction services in the United States and western Canada. At Summit Materials, we support our teammates who lay the groundwork for our communities and live by our core values: Safety, Integrity, Sustainability, and Inclusivity. We're passionate about our teammates, our work, and our communities. Each of Summit's companies celebrates their individual legacies, but together - we are Summit Materials. At Summit Materials, we provide the foundation to connect our communities today and build a better tomorrow. We value all our communities - including our diverse internal community of teammates that make us stronger. No matter your race, ethnicity, gender, age, or anything that makes you who you are...you belong. Req #: 1810
    $64k-85k yearly est. 23d ago
  • Quality Assurance Manager

    Idex Corporation 4.7company rating

    Quality engineer job in Ocala, FL

    If you're looking for a special place to build or grow your career, you've found it. Whether you're an experienced professional, a recent college graduate or somewhere in between, IDEX is a place where you can apply your existing skills and learn new ones in an environment where you can make an impact. With interesting opportunities in engineering, marketing, sales, supply chain, operations, HR, finance, and more across more than 40 diverse businesses (*********************************************************** around the globe, chances are, we have something special for you. Responsible for developing, deploying and leading the organization in a variety of quality processes and concepts that improve business performance and driving critical actions and results that align to the IDEX operating model and support the business goals. Develops, implements and coordinates the quality program to prevent or eliminate defects in new or existing products and systems by performing the following duties personally or through subordinates. DUTIES AND RESPONSIBILITIES + Administers and oversee all ISO 9001:2015 quality system requirements within the Ocala site. + Oversees the quality department processes and resources for Hale Products. + Ability to analyze and resolve process issues varying from basic to very complex. + Drive corrective actions, identifies trends, assists in problem resolution and ensures responsible parties meet their commitments. + Implements a successful Material Review process which includes dispositioning non-conforming components identifying components, identifying appropriate root cause and implementing corrective action on non-conforming to prevent recurrence. + Performs assessments and audits on processes and procedures to ensure compliance to specifications, engineering drawings, procedures as required by Hale's ISO commitments. + Interfaces with customers, suppliers and program personnel on quality related issues. + Apply statistical analysis using the DMAIC (Define, Measure, Analyze, Improve and Control) process to determine necessary course of action to improve or resolve issues. + Recommend and develop methods for improving utilization of equipment, personnel, material, and workspaces across the business. + Estimate financial impact of current and proposed change recommendations for management review, action, and controls. + Define and review product specifications necessary to establish quality and reliability objectives. + All other duties as assigned. KNOWLEDGE, SKILLS AND REQUIRED ABILITIES + Identifies, recruits, and develops the strongest talent. + Ability to influence and strategically partner with individuals of various educational and technical backgrounds, both inside and outside the organization. + Bias for action; drive to achieve results and goals in the short and long term. + Ability to define problems, collect data, establish facts and draw valid conclusions while fostering cross-functional/global problem solving and cooperation. + Ability to work independently and collaboratively with others toward mutual objectives. + Ability to communicate and enlist support for the vision of the organization. + The ability to adapt to work effectively in an environment of change, uncertainty, and ambiguity; can make pragmatic decisions in a timely fashion, especially when there is not a clear "right way." + Proficiency in Microsoft Office applications. + Strong leadership and influence skills, with and without direct authority. + Strong Project Management Skills + Excellent interpersonal, verbal and written skills. EDUCATION AND EXPERIENCE + BS in Manufacturing or Engineering, MBA preferred. + Minimum of 7-10 years quality management experience in a manufacturing environment + 5+ years experience with Supplier Approvals, Quality and Six Sigma tools (e.g. 8D's, PPAP's, VSM's, STD WORK, FMEA, GAGE R&R, DOE's as it relates to the DMAIC process). + Strong history of driving process improvements and implementing error-proofing strategies to eliminate defects proactively. PHYSICAL DEMANDS The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this position. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this position, the employee is regularly required to stand and walk. The employee is occasionally required to sit, climb or balance and stoop, kneel, crouch, or crawl. The employee must be able to lift and/or move up to 40 pounds or over 40 pounds with assistance. Specific vision abilities required by this job include close vision and ability to adjust focus. May be exposed to various workplace hazards, including chemicals, machinery, and noise. Proper use of personal protective equipment (PPE) is essential. Are you ready to join a different kind of company where our people, our culture, and our commitments are centered around providing trusted solutions that improve lives around the world? IDEX is an Equal Opportunity Employer . IDEX gives consideration for employment to qualified applicants without regard to race, color, religion, creed, genetic information, sex, sexual orientation, gender identity or expression, marital status, age, national origin, disability, protected veteran status, or any other consideration or protected category made unlawful by federal, state or local laws. Attention Applicants: If you are an individual with a disability and require a reasonable accommodation to complete any part of the application process, please let us know. Likewise, if you are limited in the ability to access or use this online application process and need an alternative method for applying, we will determine an alternate way for you to apply. Please contact our Talent Acquisition Team at ********************** for assistance with an accommodation. These contact tools may be used only by individuals with a disability for accommodation requests. Do not inquire as to the status of an application. Job Family: Engineering Business Unit: Hale
    $77k-97k yearly est. Auto-Apply 60d+ ago
  • IT Validation Engineer 1

    Rti Surgical Inc. 4.5company rating

    Quality engineer job in Alachua, FL

    RTI Surgical is now Evergen! This rebranding reflects our strategic evolution as a leading CDMO in regenerative medicine and comes at the end of a significant year for the business, including the successful acquisitions of Cook Biotech in IN. and Collagen Solutions, MN. Our new brand identity emphasizes our unique positioning as the only CDMO offering a comprehensive portfolio of allograft and xenograft biomaterials at scale. Evergen is a global industry-leading contract development and manufacturing organization (CDMO) in regenerative medicine. As the only regenerative medicine company that offers a differentiated portfolio of allograft and xenograft biomaterials at scale, Evergen is headquartered in Alachua, FL, and has manufacturing facilities in West Lafayette, IN., Eden Prairie and Glencoe, MN., Neunkirchen, DE., Glasgow, UK., and Marton, NZ. Read more about this change and Evergen's commitment to advancing regenerative medicine here: ************************ RESPONSIBILITIES Identify and qualify all computer systems which impact cGMP operations using a risk-based methodology Develop 21 CFR Part 11 computer system validation plans, qualification test protocols, traceability matrices, reports, IQ/OQ/PQ protocols, and all other documents within the scope of the validation plan Develop and maintain test plans, test scripts, user acceptance tests, and manage the execution of test plans Maintain and improve software validation and testing processes Work with software developers and testers to write specification documents according to established procedures Design and set up product labels using Loftware, SQL, and ZPL based on requirements from stakeholders Conduct validation and testing for product labels Set up meetings with key project stakeholders to gather requirements for software development projects Conduct analysis of business processes and functional requirements Apply technical and business knowledge to analyze stakeholder requirements and document as part of the software validation process Work with cross-functional leadership and functional teams to understand business requirements and investigate issues using root cause analysis for NCs, CAPAs, and projects Other duties as assigned REQUIREMENTS: Education Associate degree in computer science, information technology, or related field Experience 0-3 years of relevant experience in a regulated industry in testing, quality assurance, or validation documentation development using risk-based methodology Additional experience may be substituted for education requirements Experience with Manufacturing, ERP, quality systems, database systems, SQL is preferred Experience in Agile software development lifecycle processes is preferred Experience in regulated environments, such as FDA or AATB, is preferred Skills Excellent verbal and written communication Computer Systems Validation (CSV) methodologies using a risk-based approach Experience with Octane for manual and automated testing Advance SQL query writing Excellent problem-solving skills with ability to work in collaborative and independent working situations and environments with minimal supervision Must work and interact effectively and professionally with and for others throughout various levels of the global organization Ability to simultaneously manage multiple projects Ability to remain calm and receptive in fast-paced situations Travel Occasional travel for training and meetings as needed. Safety: Physical Requirement Move or lift objects up to 25 pounds Frequent (>75%) stationary position (standing or sitting) while utilizing digital displays Frequent (>75% fine manipulation using hands and fingers (typing, opening, writing, clicking, paper sorting, etc.) Working Environment Onsite: Office environment with assigned workstation More about Evergen: Evergen provides customers across a diverse set of market segments with leading-edge expertise, scale, and flexibility across end-to-end services including design, development, regulatory support, verification and validation, manufacturing, and supply chain management. Evergen is rooted in a steadfast commitment to quality, integrity, and patient safety with a focus on five key values: Accountable: We own our actions and decisions. Agile: We embrace change to stay ahead of the curve and evolve to drive innovation and growth. Growth Mindset: We embrace challenges as opportunities for continuous learning. Customer-Centric: We prioritize customers at every touch point. Inclusive: We thrive on the richness of our diversity and ensure every voice is heard, respected, and celebrated. At Evergen, we are committed to fostering an inclusive workplace where we embrace the richness of our diversity and ensure that every voice is heard, respected, and celebrated. We believe that by embracing diversity and promoting inclusivity, we not only uphold our values but also strengthen our position as the CDMO of Choice in regenerative medicine solutions. We recognize that cultivating a growth mindset is essential to our success, and we are dedicated to continuous learning and improvement in our diversity, equity, and inclusion efforts. Through accountability and action, we strive to create an environment where individuals can thrive, innovate, and contribute their unique perspectives to drive our collective success. Montagu Private Equity (“Montagu”), a leading European private equity firm, acquired RTI in 2020 and has supported the transformation of the company to its next level of potential. #LI-onsite
    $67k-87k yearly est. Auto-Apply 45d ago

Learn more about quality engineer jobs

How much does a quality engineer earn in Gainesville, FL?

The average quality engineer in Gainesville, FL earns between $51,000 and $89,000 annually. This compares to the national average quality engineer range of $61,000 to $103,000.

Average quality engineer salary in Gainesville, FL

$67,000
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