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  • Manager, Training and Quality Management (Remote)

    Airbus Americas, Inc. 4.9company rating

    Remote quality assurance manager job

    Airbus is committed to providing reasonable accommodations as an Equal Opportunity Employer to applicants with disabilities. If you require assistance or an accommodation to complete your application, please contact us at * Notice: Pay Transparency Nondiscrimination (English) * Transparencia en el Pago No Discriminacio ́n (Spanish) **Airbus US Manufacturing Facility is looking for a Aircraft Manager A320 to join our Project Manager Team based in Mobile, AL** * The ideal candidate is responsible for folio management of any assigned aircraft during the production and flight test phase of the assembly process until Handover to the delivery center is complete. * **Manufacturing facilities help assemble the finest aircraft in the world, along two (soon to be three) production lines for the A220 and A320 Family aircraft. On the shop floor you'll be surrounded by individuals who are passionate about aviation and skilled in areas like electrical, structure and quality. Join our team and help build the next generation of aircraft. * **Manufacturing Facility for commercial aircraft. Opened at the Mobile Aeroplex at Brookley in 2015, the facility produces A320 Family aircraft and added a second product line for the A220 in 2019. The facility, which strengthens the U.S. aerospace industry, is part of Airbus' strategy to enhance its global competitiveness by meeting the growing needs of its customers in the United States and beyond. * How we car for you: * **Financial Rewards:* Competitive base salary, incentive compensation which may include profit sharing schemes, retirement savings plan and the ability to participate in an Employee Stock Ownership Plan ("ESOP") * * **Work/Life Balance: * Paid time off including personal time, holidays and a generous paid parental leave program. * * **Health & Welfare: * Comprehensive insurance coverage including medical (traditional and high-deductible health plans), prescription, dental, vision, life, disability, Employee Assistance Plan ("EAP") and other supplemental benefit coverages. * * **Individual Development: * Upskilling and development opportunities through our global Leadership University, including unlimited access to 10,000+ e-learning courses focusing on ways to develop your employability, certifications, career path as well as the opportunity to participate in accelerated development programmes and both national and international mobility. * **Document, follow, organize and manage all non-conformities throughout the flowline/flightline process. Prepare Aircraft Documentation for the Internal Quality Gates and lead meetings to ensure aircraft status is known by the receiving station. In the event of a red quality gate, ensure actions are taken and completed according to plan given** * **Ensure all escalations are properly documented in Tandem and all information is given for appropriate problem solving.** * **Create the MSN status report and send updates on an on-going basis regarding the progress of the aircraft. Guarantees that all information in "Aircraft Progress" concerning the FAL are in accordance with the physical state of the subject aircraft.** * **Responsible for aircraft issue follow-up addressing progress in a proactive manner, anticipating issues, and driving resolution to avoid production risks. Generate the daily MSN Report (folio point's analysis) and highlight priority topics.** * **Responsible for Working Party planning when necessary to solve major issues on aircraft.** * **Record information in "Aircraft Progress" and define daily priorities with the Station Managers.** * **Cooperate in national/international projects.** * **A Bachelor's degree in Business Administration or a related field. In lieu of degree, training as a technician in a technical field related to aviation manufacturing.** * **Required: 3 or more years' of working experience in aviation related fields or equivalent experience in manufacturing planning or manufacturing project management.** * **Preferred: 1 year of working experience in a leading role.** Vision: adequate to enter and read material on computer screens. Hearing: able to hear sufficiently to engage in conversation in office settings Able to hear alerts and warning signals.* * *Equipment Operation: Able to operate a wide range of personal and office electronic equipment* * *Carrying: able to occasionally carry up to 20lbs/9kg while engaging in training, addressing production issues or as part of continuous improvement projects.* * *Pushing/Pulling: able to push/pull items in office areas and on the shop floor* * *Sitting: able to sit for extended periods of time at the computer and in meetings.* * *Travel: able to travel* * *Walking: able to walk through office and production areas, around flight lines and airstrips and sometimes on uneven indoor and/or outdoor surfaces.* * Take your career to a new level and apply online now! * This job requires an awareness of any potential compliance risks and a commitment to act with integrity, as the foundation for the Company's success, reputation and sustainable growth. ****Airbus Americas, Inc. *Remote Type:* On-site *Assembly & Integration ------ Airbus provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, genetics, pregnancy, marital status, veteran status or other legally protected status. In addition to federal law requirements, Airbus complies with applicable state and local laws governing nondiscrimination in employment in every location in which the company has facilities. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, demotion, termination, layoff, recall, transfer, leaves of absence, compensation, benefits and training. Airbus expressly prohibits any form of workplace harassment based on race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, genetics, pregnancy, marital status, veteran status or other legally protected status. As a matter of policy, Airbus does not sponsor visas for US positions unless specified. This position description does not constitute a written or implied contract of employment. By submitting your CV or application you are consenting to Airbus using and storing information about you for monitoring purposes relating to your application or future employment. Airbus is committed to achieving workforce diversity and creating an inclusive working environment. We welcome all applications irrespective of social and cultural background, age, gender, disability, sexual orientation or religious belief.
    $75k-103k yearly est. 1d ago
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  • Quality Manager - Automotive

    Plastic Executive Recruiters

    Quality assurance manager job in Columbus, OH

    AUTOMOTIVE QUALITY MANAGER This role leads the quality function for a Tier 1 automotive manufacturing operation, with responsibility spanning injection molding, secondary processes, assembly, and end-of-line testing. The Quality Manager owns plant-wide quality performance, customer-facing quality issues, and the continuous improvement systems that support long-term operational stability. KEY RESPONSIBILITIES Lead and develop a multi-shift Quality organization, including quality engineers, team leaders, and technicians Drive plant-wide quality improvement initiatives across injection molding, secondary operations, assembly, and testing processes Establish, maintain, and improve quality systems aligned with automotive customer and certification requirements Own customer quality performance including complaints, audits, safe launches, and corrective actions Lead supplier quality improvement activities including audits, performance reviews, and corrective action follow-up Implement and maintain structured continuous improvement programs such as layered process audits, 6S, and critical process tracking Develop and manage quality documentation including SOPs, control plans, PFMEAs, inspection standards, and work instructions Train and develop the quality team in structured problem-solving and continuous improvement methodologies, including Six Sigma Track quality metrics, identify trends, and lead countermeasure development through cross-functional collaboration Communicate quality performance, risks, and improvement plans to plant leadership and senior management REQUIREMENTS Bachelor's degree in Engineering or related technical field, or equivalent experience 8+ years of quality experience in an automotive manufacturing environment 2+ years of leadership experience managing quality teams Strong working knowledge of automotive quality systems, customer requirements, and audit processes Experience leading corrective actions, supplier quality initiatives, and new program launches Background in continuous improvement methodologies such as Six Sigma or similar structured approaches Proficiency with Microsoft Office tools and quality reporting systems Confident communicator who can advocate for the plant when working with customers and suppliers BENEFITS Relocation assistance available Comprehensive benefits package including medical, dental, vision, life insurance, 401(k) match, and tuition assistance This is an onsite leadership role within a fast-paced automotive manufacturing environment. Visa sponsorship is not available. Explore more opportunities at **************************
    $67k-104k yearly est. 1d ago
  • Quality Intelligence Project Manager

    Akkodis

    Quality assurance manager job in Columbus, OH

    Akkodis is seeking a Quality Intelligence Project Manager for a 10 months contract opportunity with a client in Columbus OH(Onsite). Rate Range: $43/hour - $45/hour.; The rate may be negotiable based on experience, education, geographic location, and other factors. About the Role We are seeking an experienced Quality Intelligence Project Manager to join our Commercial QA Global Strategy team. In this critical role, you will lead multiple medium to large-scale quality and compliance projects, ensuring global regulatory requirements are effectively assessed, implemented, and sustained across manufacturing sites, affiliates, and the supply chain. You will work cross-functionally with Manufacturing, R&D, Regulatory Affairs, Supply Chain, and Quality teams to drive compliance initiatives, strengthen quality systems, and proactively manage regulatory changes impacting our global operations. This role offers high visibility and plays a key part in protecting product quality, regulatory compliance, and business continuity. Qualifications Required: Bachelors degree in a relevant discipline/or equivalent work experience is required (Business Administration, Chemistry, Microbiology, Food Science, Engineering). 5-7 years in a regulated nutritional food-manufacturing environment, preferably pediatric or medical nutrition products, in a Quality, R&D, Project Management, Procurement or Operations function and good knowledge of food GxP and nutritional regulations. Knowledge in nutritional manufacturing controls and quality systems. 3-5 years' experience in project leadership roles. Critical thinking/problem-solving skills. Well-developed interpersonal, communication and negotiation skills. Ability to plan and facilitate meetings. Effective Stakeholder Management Experience in working with international locations and partners Preferred Master's degree Project Management Professional (PMP) certification by the Project Management Institute (PMI) Ingredient expertise, process expertise, and formulation expertise in nutritional and infant concepts. Continuous improvement methods and application (for example: Lean, Six Sigma, Class A, etc.). If you are interested in this role, then please click APPLY NOW. For other opportunities available at Akkodis, or any questions, feel free to contact me at ****************************. Equal Opportunity Employer/Veterans/Disabled Benefit offerings available for our associates include medical, dental, vision, life insurance, short-term disability, additional voluntary benefits, an EAP program, commuter benefits, and a 401K plan. Our benefit offerings provide employees the flexibility to choose the type of coverage that meets their individual needs. In addition, our associates may be eligible for paid leave including Paid Sick Leave or any other paid leave required by Federal, State, or local law, as well as Holiday pay where applicable. Disclaimer: These benefit offerings do not apply to client-recruited jobs and jobs that are direct hires to a client. To read our Candidate Privacy Information Statement, which explains how we will use your information, please visit ****************************************** The Company will consider qualified applicants with arrest and conviction records in accordance with federal, state, and local laws and/or security clearance requirements, including, as applicable: · The California Fair Chance Act · Los Angeles City Fair Chance Ordinance · Los Angeles County Fair Chance Ordinance for Employers · San Francisco Fair Chance Ordinance
    $43 hourly 3d ago
  • Remote QA Lead - Build Quality for AI-Driven Product

    Truelogic Software LLC 4.0company rating

    Remote quality assurance manager job

    A leading tech firm in New York is seeking a QA Lead to establish and own the QA function for an AI-driven product. This role involves designing QA processes and collaborating closely with engineering teams. Ideal candidates will have strong experience in QA methodologies and enjoy a fully remote work environment. The position offers highly competitive USD pay, autonomy in work, and the opportunity to collaborate with top American companies on impactful projects. #J-18808-Ljbffr
    $97k-125k yearly est. 4d ago
  • Senior Quality Consultant - Bilingual (Spanish/English)

    Pharmatech Associates 3.6company rating

    Remote quality assurance manager job

    A leading life sciences consultancy is seeking a Senior-level Quality Consultant to assist with delivering quality and compliance-related services. Candidates should have a B.S. in life sciences, 15 years of relevant experience, and bilingual skills in Spanish and English. Responsibilities include conducting gap assessments and evaluating inspection readiness programs. Remote work is available, and strong interpersonal and communication skills are essential. #J-18808-Ljbffr
    $67k-87k yearly est. 20h ago
  • Research And Development Manager

    Bellisio Foods 4.1company rating

    Quality assurance manager job in Columbus, OH

    R&D Manager The Research and Development (R&D) Manager at CP Foods North America will lead the planning, execution, and completion of new product development and existing product optimization projects, from concept through commercialization. This role requires a blend of scientific expertise, project management skills, and innovative thinking to ensure products meet market demands, quality standards, and regulatory requirements. The R&D Manager will foster a culture of innovation and collaborate closely with cross-functional teams including Marketing, Sales, Quality Assurance (QA), Operations, and Supply Chain. Key Responsibilities Product Development & Innovation: Drive the development of new and innovative food products and improve existing formulations to meet consumer needs and market trends. Project Management: Oversee the R&D projects supported by the Columbus R&D team, ensuring projects are completed on time, within budget, and align with company objectives. Team Leadership: Manage and mentor a team of food technologists and technicians, fostering a collaborative and innovative work environment. Technical Expertise & Analysis: Provide technical leadership and support, including formulation, shelf-life stability testing, and sensory evaluation, for the projects supported by the R&D team. Strong knowledge of scientific process and application of experimental design in lab experiments and plant trials, including statistical analysis of results. Scale-Up & Commercialization: Ensure trials have strong technical plans and are designed to ensure a seamless transition from lab to manufacturing. Partner with the Engineering, Quality and Operations teams to enable efficient start-up. Quality & Regulatory Compliance: Work with quality and regulatory teams to ensure all products and processes comply with industry regulations and food safety standards (e.g., FDA, USDA, HACCP, GMPs, SQF). Cross-Functional Collaboration: Partner with Marketing to translate consumer insights into project briefs, with Operations to ensure manufacturing feasibility, and with Procurement to source new ingredients and manage costs. Documentation & Reporting: Maintain comprehensive documentation for product specifications, formulations, processing protocols, and project progress reports. Responsible for accurate documentation and protocol management for lab and pilot plant space in Columbus. Qualifications & Skills Education: Bachelor's or Master's degree in Food Science, Food Engineering, Culinary Science, or a related scientific field. Experience: Minimum of 5-10 years of R&D experience in the food manufacturing industry. Proven experience managing R&D projects and leading cross-functional teams, experience with people management preferred. Experience with commercializing products from concept to launch. Technical Skills: Strong knowledge of ingredient functionality, food chemistry, processing techniques, and food safety systems. Related Skills: Excellent problem-solving, analytical, and critical thinking abilities. Strong leadership, communication, and interpersonal skills. Ability to manage multiple projects, prioritize tasks, and adapt to a fast-paced environment Champions a “What If” attitude, searches and provides new ideas and solutions Values collaboration and the power of team Other job responsibilities as assigned Location: Columbus, OH Disclaimer This job description indicates in general the nature and levels of work, knowledge, skills, abilities and other essential functions (as covered under the Americans with Disabilities Act) expected of an incumbent. It is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities required of an incumbent. Duties, responsibilities and activities may change at any time with or without notice.
    $67k-104k yearly est. 2d ago
  • Senior Quality Systems Engineer (Remote) - Drive QMS Excellence

    Getinge 4.5company rating

    Remote quality assurance manager job

    A global medical device company is seeking a Senior Quality Systems Engineer for a remote position. The role involves leading the enhancement of Quality Management System documents, driving best practices, and ensuring regulatory compliance. Candidates should have at least 5 years of experience in Quality Assurance with a strong understanding of medical device regulations. Comprehensive benefits package including health insurance and a registered pension plan is offered. #J-18808-Ljbffr
    $78k-103k yearly est. 2d ago
  • Western US Regional Quality Manager

    E2 Optics 4.1company rating

    Remote quality assurance manager job

    Why E2 Optics? 🔌Join E2 Optics as an Western US Regional Quality Manager!🔌 Are you ready to elevate your career with an award-winning, Woman-Owned technology integrator that's leading the charge in the data center revolution? E2 Optics is one of the fastest-growing and most stable companies at the core of the tech industry-powering the infrastructure behind AI, cloud computing, and the innovations of tomorrow. At E2 Optics, you will work with cutting-edge systems in some of the most advanced environments in the world. We invest in your growth through hands-on experience, industry certifications, and leadership opportunities that put you in charge of teams and outcomes. Collaboration is in our DNA-we believe in lifting each other up, mentoring with purpose, and celebrating every win. If you're looking to be part of something meaningful, fast-moving, and future-focused, your next opportunity is here. Join one of America's largest and fastest-growing tech integrators and help us shape what's next. What You'll Do Safety is E2 Optics' number one Core Value. All employees are expected to follow safe work practices, as well as adhere to company and client worksite safety policies and procedures. Promotes company Core Values to foster and safeguard family-centric culture. In cooperation with the Director of Quality, develops and manages corporate quality initiatives to build a world class program for US operations with the exception of one specific Strategic Account. Works with personnel in all areas and at all levels to achieve consistent Quality management practices throughout the US. Provides support to regional field leadership helping them build and maintain awareness of developing Quality Management solutions and adopt best practices. Maintains Quality Management programs for incorporation into the operational policies of the organization to provide regional construction operations leadership and consistency. Determines corrective or preventative measures where indicated and verifies measures have been implemented. Communicates the expectations, goals, standards, and metrics used to measure progress. Attends and supports required Quality Management meetings will all levels of both internal and external parties. Develops, follows-up and verifies completion of action items based off KPI's. Maintains Quality Management leadership and awareness skills among site Quality Managers to support compliance with internal and external requirements. Manages Quality training needs in accordance with both E2 Optics and customer guidelines. Provides technical and regulatory compliance expertise and support throughout the US operations under this description. Leads the investigation of quality challenges at region sites and cooperates in the preparation of material and evidence for organization use in lessons learned communications. Reviews, compiles and submits Quality Management reports required by strategic account operation under this description. Develop and execute the company-wide strategy for Quality Assurance (QA), Quality Control (QC), and Technical Training across all operations. Lead cross-functional quality programs to ensure consistent standards and continuous improvement across field operations. Define, standardize, and continuously improve QA/QC procedures specific to structured cabling, OSP, AV, DAS, and data center systems. Oversee jobsite inspections, audits, and closeout documentation to ensure work meets NEC, BICSI, TIA, and customer-specific standards. Oversee inspections, audits, and compliance efforts to meet internal standards and industry regulations. Collaborate with project, field, and engineering teams to identify quality gaps and implement corrective actions. Support ongoing workforce development, leadership training, and career pathing for technical roles. Support onboarding and certification programs for new hires, including BICSI and client-specific requirements. Support a technical training organization that equips employees with knowledge, certifications, and hands-on skills to perform at the highest level Establish and monitor KPIs and metrics for quality performance and training effectiveness. Champion a culture of accountability, safety, and continuous learning across the organization. Lead, mentor and support QA/QC and technical training teams across multiple locations. Travel: The individual in this role should be able and willing to travel as required by E2 Optics. What We Are Looking For Bachelor's Degree preferred in Engineering, Construction Management, Business, or related field. 5 + years Quality Management experience in progressively responsible leadership roles will be considered in lieu of a bachelor's degree. BICSI RCDD, PMP, or equivalent certifications preferred. Administration and Management: knowledge of business and management principles involved in strategic planning, resource allocation, standard modeling (SOP), leadership technique, production methods, and coordination of people and resources. Law and Government: knowledge of laws, legal codes, government regulations, and requirements. Building and Construction: knowledge of materials, methods, and the tools involved in the construction or repair of buildings, or other structures within Regional Datacenters. Proficient in using a computer and MS Office (Outlook, Word, Excel, Visio, etc.) and MS Project. 5+ years progressively responsible leadership roles with quality management experience in the low voltage, structured cabling, or data center construction industries. Experience understanding of BICSI standards, ANSI/TIA codes, and electrical/communications best practices. Extensive knowledge of QA/QC frameworks, regulatory standards, and technical best practices. Proven ability to build and scale quality programs in high-growth and field-based environments. What We Offer Competitive pay Opportunities for professional development and career growth BICSI training facilities A supportive and inclusive work environment Health, dental, and vision insurance Paid time off and holidays Work Environment and Physical Demands The standard work environment for this position includes both indoor business office settings and construction environments. The noise level is usually moderate. While performing the duties of this job, the employee is regularly required to sit, talk or hear, use hands, stoop, kneel, reach with hands and arms, and talk or hear. The employee is frequently required to stand and walk. The employee must regularly lift and/or move up to 50 pounds and frequently lift and/or move up to 25 pounds. The employee must also regularly carry and climb ladders up to 20 feet. The employee must be able to operate equipment such as scissor lifts, telehandlers, boom lifts, and UTVs (buggies), if required. The employee may also be required to work in tight, confined spaces. The physical demands described here are representative of those that must be met to successfully perform the essential functions of this job. When possible, reasonable accommodation may be made to enable individuals with disabilities to perform these essential functions. Disclaimer The above job definition information is intended to describe the general nature and level of work performed by employees within this classification. It is not intended to contain or be interpreted as a comprehensive inventory of all duties, responsibilities, and qualifications required of employees assigned to this job. Job duties and responsibilities are subject to change based on evolving business needs and conditions.
    $74k-109k yearly est. Auto-Apply 13d ago
  • Data Center QA/QC Manager

    Vertex Innovations 4.7company rating

    Remote quality assurance manager job

    Vertex Innovations is seeking an experienced Data Center QA/QC Manager to support ground-up, mission-critical data center projects from break ground through final turnover. This role ensures construction quality, system compliance, and readiness for commissioning across civil, structural, and MEP scopes. Location: Initial Site Location: Dallas, TX (local candidates only - must be within daily commuting distance. Required to be on-site.) This position is considered remote work. While the initial site location is specified above, we are seeking candidates who are willing and able to travel 100% to various client project sites each week as assigned. Key Responsibilities: Lead QA/QC efforts for ground-up data center construction projects. Develop and manage project-specific QA/QC plans. Perform routine inspections across civil, structural, and MEP scopes. Identify deficiencies, issue punch lists, and track corrective actions. Verify compliance with IFC drawings, specifications, and approved submittals. Coordinate with GCs, subcontractors, vendors, and commissioning teams. Review PFCs, FPTs, startup documentation, and inspection reports. Support L1L5 commissioning, IST, load bank testing, and system energization. Review megger testing, IR scans, pressure testing, and cable certification. Oversee O&M manuals, as-builts, warranties, and turnover documentation. Participate in AHJ inspections and owner walkthroughs. Ensure compliance with OSHA and site safety requirements. Qualifications: Education: Bachelors degree in Engineering, Construction Management, or related field (or equivalent experience). Relevant certifications, such as Project Management Professional (PMP), Certified Commissioning Professional (CCP), ASHRAE Commissioning Process Management Professional (CPMP), or LEED Accredited Professional, are a plus. OSHA 30 Construction certification Experience & Skills: 7+ years of QA/QC experience on mission-critical or data center projects. Strong knowledge of ground-up construction sequencing and site development. Deep understanding of electrical, mechanical, BMS, Fire Life Safety, Access Control, and critical systems. Experience with UPS, generators, switchgear, PDUs, CRAH/CRAC units, and cooling systems. Ability to interpret construction drawings, specifications, and test reports. Experience supporting commissioning and integrated systems testing. Proficiency with Procore, Bluebeam, Smartsheet, and QA/QC tracking tools. Strong communication, documentation, and organizational skills. Ability to travel as required. Preferred Qualifications Hyperscale or colocation data center experience. Familiarity with ASHRAE, NFPA, IEEE, and Uptime Institute standards. Commissioning or QA/QC certifications. Experience with Cx Alloy and Primavera P6. Working Conditions: Initially must be within daily commuting distance to Dallas, TX site location Willing and able to do weekly travel to various data center project sites, as assigned Ability to work in construction and industrial environments, including exposure to varying temperatures and noise levels. May involve extended hours during critical project phases. Compensation: $100,000 - $150,000, dependent on experience and location Health Benefits: Medical, Dental, Vision, LTD/STD, Life-AD&D Retirement: 401(k), discretionary Pension & Profit sharing, subject to Plan documents 15 days paid time off (prorated based on start date) and 8 holidays About Vertex Vertex Innovations, Inc. is a Colorado company founded in 2003 by Wayne and Erica Smith. "We could see where the future of communications was heading and wanted to take our passion and skill to build the nations telecommunications infrastructure." Since those early days, Vertex Innovations has managed the buildout of todays wireless and fiber networks connecting millions of Americans and improving their daily lives. Our mission is to use our talents, experience, knowledge, and determination to create a connected society where everyone has the opportunity to foster connections, obtain knowledge, and create an impact on society. At Vertex these Core Values created by our team are our guide in creating todays connected society. Integrity To move through the world with honesty and truth empowering our employees, clients and communities through our words and actions. Accountability To take full ownership and responsibility in our roles as we serve our company, clients and communities. Commitment To stand behind our word and our promises Respect To embrace and honor the individuals, clients, and companies in their contribution to the work that we create together through our interactions, conversations and our way of being. Performance To allow ourselves to be measured by our commitments and be accountable for every action to our employees, clients, and communities. VERTEX Innovations, Inc. provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state, or local laws. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation, and training.
    $100k-150k yearly 12d ago
  • Director, Quality Assurance GCP

    Crinetics Pharmaceuticals 3.9company rating

    Remote quality assurance manager job

    Crinetics is a pharmaceutical company based in San Diego, California, developing much-needed therapies for people with endocrine diseases and endocrine-related tumors. We were founded by a dedicated team of scientists with the simple belief that better therapies developed from rigorous innovation can lead to better lives. Our work continues to make a real difference in the lives of patients. We have a prolific discovery engine and a robust preclinical and clinical development pipeline. We are driven by science with a patient-centric and team-oriented culture. Crinetics is known for its inclusive workplace culture. We are also a dog-friendly workplace. This is an exciting time to join Crinetics as we shape our organization into the world's premier fully-integrated endocrine company from discovery to patients. Join our team as we transform the lives of others. POSITION SUMMARY: The Director, Quality Assurance (GCP) oversees the development, implementation, maintenance, and performance of GCP Quality Assurance systems both within company and external vendors. The Director will execute and/or ensure proper oversight of the GCP QA audit program management, clinical operations phase 1 to phase 4 study team support, regulatory inspections, and GCP QA infrastructure development. ESSENTIAL FUNCTIONS AND RESPONSIBILITIES: These may include but are not limited to: General Provide GCP quality assurance strategy and oversight of QA GCP operations Ensures that clinical trials and research activities adhere to regulatory requirements, industry standards, and internal policies Develop and implement risk management strategies to identify, assess, and mitigate risks Drive effective initiatives that foster a culture of quality and continuous improvement Successfully collaborate on multiple projects with cross-functional stakeholders Lead investigations of significant complexity Prepare and present to executive management Manage, lead, and mentor quality assurance team members; lead cross-functional teams on compliance projects Audit Management Develop a plan with CROs for clinical sites' audit execution Manage clinical site, TMF, and GCP and GLP vendor audit activities Generate and/or review and approve overall GCP QA audit plans and schedules Generate and/or review and approve audit trend reports Execute the GCP QA audit program to ensure that processes and systems are adequate for communicating, addressing, and preventing identified GCP compliance issues and trends Study Team Support & Issue Escalation Management Represent QA at program-wide (e.g., study team or governance) meetings and provide GCP guidance and feedback Serve as point of escalation for GCP compliance issues identified by clinical study teams or QA leads, and responsible for informing the head of QA and Management, as required Manage quality events, CAPAs, and deviations Collaborate with cross-functional teams (Clinical Operations, Clinical Research, Regulatory, etc.) to embed quality by design in clinical programs. Provide guidance and support to Trial Master File activities Quality Systems / Inspections / Infrastructure Ensure adequate systems and controls are in place for GCP compliance Identify and address quality systems gaps, including internal processes and personnel GCP training Execute the review of GCP SOP tracking and status reports to ensure timely review and development of SOPs Author, review, or revise SOPs related to clinical and non-clinical studies Develop and provide GCP training Support regulatory inspection activities and GCP inspection readiness activities Prepare internal team, clinical sites, and vendors for inspection readiness Thoroughly review clinical study documents Perform breach assessments Oversee quality vendor management and governance for GCP and GLP vendors Review Quality Agreements to ensure clear delineation of responsibilities and compliance expectations between the sponsor and the vendor Contribute and present GCP quality events and metrics at the Quality Management Review meeting Support other Quality Assurance and Quality Systems activities Other duties as assigned. Education and Experience Required: Minimum Bachelor's degree in a science discipline and at least 12 years' experience in a QA function within the pharmaceutical/biotech industry (an equivalent combination of experience and education may be considered) Minimum of 8 years of working in a GCP QA function Previous experience leading inspection readiness and audits Thorough understanding of FDA, EU and local regulations, as well as understanding of ICH guidelines Hands-on experience in developing and implementing GCP procedures Strong working knowledge of GCP and GLP regulations Proven ability to cultivate and develop relationships with cross functional teams and vendors Demonstrated leadership ability to identify, manage and develop QA teams Must be able to make critical and strategic decisions based on risk-assessments Capable of managing multiple projects simultaneously Excellent communication and listening skills Preferred: Auditing certification is a plus Physical Demands and Work Environment: Physical Activities: On a continuous basis, sit at desk for a long period of time; intermittently answer telephone and write or use a keyboard to communicate through written means. Some walking and lifting up to 25 lbs. may be required. The noise level in the work environment is typically low to moderate. The physical demands described above are representative of those that must be met by an employee to successfully perform the essential functions and responsibilities of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions and responsibilities. Laboratory Activities (if applicable): Biology and chemical laboratory environment experience needed. Environmental health and safety requirements also apply. Travel: You may be required to travel for up to 10% of your time. The Anticipated Base Salary Range: $176,000 - $220,000 In addition to your base pay, our total rewards program consists of a discretionary annual target bonus, stock options, ESPP, and 401k match. We also provide top-notch health insurance plans for employees (and their families) to include medical, dental, vision and basic life insurance, 20 days of PTO, 10 paid holidays, and a winter company shutdown. The final salary offered to a successful candidate will be dependent on several factors that may include but are not limited to the type and length of experience and education. Crinetics Pharmaceuticals is a multi-state employer, and this salary range may not reflect positions that work in other states. Your recruiter can share more about the specific salary range during the hiring process. Equal Opportunity Employer: Crinetics is proud to be an Equal Opportunity Employer. We provide equal employment opportunities to all employees and employment applicants without regard to unlawful considerations of sex, sexual orientation, gender (including gender identity and/or expression), pregnancy, race, color, creed, national or ethnic origin, citizenship status, religion or similar philosophical beliefs, disability, marital and civil union status, age, genetic information, veteran status or any personal attribute or characteristic that is protected by applicable local, state or federal laws. Vaccination requirement: Following extensive monitoring, research, consideration of business implications, and advice from internal and external experts, Crinetics requires that all employees and contractors be fully vaccinated and have received the COVID-19 vaccines as a condition of employment. “Full vaccination” is defined as two weeks after both doses of a two-dose vaccine or two weeks since a single-dose vaccine has been administered. Anyone unable to be vaccinated, either because of a sincerely held religious belief or a medical condition or disability that prevents them from being vaccinated, can request a reasonable accommodation. Salary Range The salary range for this position is: $180,000 - $225,000. In addition to your base pay, our total rewards program consists of a discretionary annual target bonus, stock options, ESPP, and 401k match. We also provide top-notch health insurance plans for employees (and their families) to include medical, dental, vision and basic life insurance, 20 days of PTO, 10 paid holidays, and a winter company shutdown.
    $180k-225k yearly Auto-Apply 50d ago
  • Quality Assurance Manager

    9Th Way Insignia

    Remote quality assurance manager job

    9th Way Insignia is a service-disabled, veteran-owned small business bringing transformative technology to our government customers so they can achieve their missions. Our specialties include cybersecurity, cloud modernization, software development, data analytics, enterprise architecture, enterprise IT, analytics, process automation, and artificial intelligence. Learn more about 9th Way Insignia at **************************** Application password: Niner This position is contingent upon contract award. Professional Level Engineer 3 Responsibilities Develop and execute a Quality Assurance (QA) Plan and provide updates as necessary throughout the task order's performance in accordance with established business practices. Validate and ensure the integrity of data through its journey from the source systems to the Data Warehouse repository and any resulting product made available to any user. Perform defect tracking and reporting, quality control and quality analysis and provide documentation to support the verification section of the QA plan to ensure the project outputs meet the defined acceptance criteria. Develop and implement a comprehensive QA strategy that aligns with company policy and project objectives. Establish and maintain IT quality standards and metrics. Oversee the development and execution of test plans and scripts for software validation. Manage both manual and automated testing processes. Continuously evaluate and improve QA processes and methodologies. Hire, train, and evaluate QA team members. Provide leadership and guidance to ensure team cohesion and professional growth. Collaborate with IT project managers, developers, and business stakeholders to ensure quality objectives are met. Communicate QA progress, risks, and results to senior management. Identify potential quality risks in software releases and create risk mitigation strategies. Lead the investigation and resolution of quality issues. Maintain comprehensive documentation of QA processes and test outcomes. Generate regular reports on QA metrics and performance. Requirements Bachelor's Degree in technical discipline; Associates Degree and 4 years of experience; 8 years of experience in lieu of degree to meet education requirement 4+ Years of experience in Quality Assurance Management Proficiency in quality management methodologies. Proficiency in quality improvement methodologies and tools (Six Sigma, Lean) Excellent leadership and interpersonal skills, with the ability to motivate and manage diverse teams. Strong problem-solving abilities and a proactive approach to issue resolution. Effective communication skills, both written and verbal, for conveying complex technical concepts to non-technical stakeholders. Detail-oriented mindset with a focus on delivering high-quality results. Must be authorized to work in the U.S. Must be able to obtain and maintain the required security clearance. Salary Range$98,153-$160,000 USD 9th Way Insignia's range for this job level is a general guideline only and not a guarantee of compensation or salary. Additional factors considered in extending an offer include (but are not limited to) responsibilities of the job, education, experience, knowledge, skills, and abilities, as well as internal equity, alignment with market data, applicable bargaining agreement (if any), or other law. Clearance/Background Investigation Applicants selected will be subject to a security investigation and may need to meet eligibility requirements for access to classified information. Benefits Eligible employees will have access to our comprehensive benefits package which includes Medical, Dental, Vision, Voluntary Life Insurance, 401(k), Basic Life A&D, STD, LTD, PTO, Telehealth, paid holidays, FSA, HSA. Additional resources include our Employee Assistance Program (EAP) and Traveling Assistance. Legal We're an equal employment opportunity employer that empowers our people to fearlessly drive change - no matter their race, color, religion, sex (including pregnancy, childbirth, lactation, or related medical conditions), national origin, age, marital status, sexual orientation, gender identity, disability, veteran status, military or uniformed service member status, genetic information, or any other status protected by applicable federal, state, or local law.
    $98.2k-160k yearly Auto-Apply 26d ago
  • Director, Clinical Quality Assurance

    Headlands Research

    Remote quality assurance manager job

    At Headlands Research, we are dedicated to enhancing clinical trial delivery within our communities. As a leading network of advanced clinical trial sites, we leverage cutting-edge technology and exceptional support services to broaden outreach and participation. Founded in 2018, our rapidly growing company currently operates 20+ sites across the US and Canada, with plans for further expansion. The Company At Headlands Research, we are building a best-in-class site network to improve the delivery of clinical trial options in the communities we serve. We're an exceptional family of next-generation clinical trial sites, integrating cutting edge technology and high-quality support services, and significantly expanding outreach and participation with a focus on participant diversity. Founded in 2018, our company is in high growth mode; we operate 21 clinical trial sites in the US and Canada and have rapid expansion plans. The Role The Director of Quality is tasked with ensuring that Headlands delivers consistent, high-quality data to our pharma partners as well as ensuring patient safety during the trial process. This individual will oversee quality and training functions for the organization including, but not limited to, the development and maintenance of quality assurance and training programs and policies, oversight of inspections and audits, quality diligence for acquired sites, and management of SOP's and quality documents to ensure GCP and all regulatory guidelines are adhered to. In addition to strategic oversight, the Director will also serve as the Quality Leader for a group of sites. This includes hands-on support in quality reviews, audit/inspection preparation, and CAPA resolution, ensuring that sites are inspection-ready and quality standards are consistently met. Direct Reports- 3-4 This individual should bring a strong background in the clinical trial industry with specific experience supporting and leading multi-site or large research organization quality development programs. Candidates should appreciate the atmosphere of a growing company and the need to impact process development while supporting sites. Success in this position requires agility, collaboration and exceptional critical thinking and problem-solving abilities. Duties Oversee and direct the Quality Department, ensuring its alignment with the broader business strategy and adherence to industry standards, while establishing clear goals and promoting a culture of quality, compliance, and ongoing improvement. Communicate, train, and author (when applicable) Standard Operating Procedures (SOPs) including periodic review/revisions of procedures and policies to ensure compliance with regulations and guidelines in both the US and Canada. Develop and maintain key performance indicators (KPIs) to evaluate the effectiveness of quality assurance activities and initiatives. Conduct and/or oversee annual and monthly quality reviews. Support the corporate development team through quality review of potential acquisition candidates. Developing and monitoring employee training as applicable to quality, including GCP, IATA, PHI, KnowB4, etc. Develop, implement, and maintain an internal review monitoring system and schedule. Report out on quality trends and metrics to aide in effective process improvement and risk management. Works with Regional Director of Operations, Quality Managers and Site Directors to ensure quality incidents are investigated, root cause analysis is performed, and a CAPA has been implemented and monitored for effectiveness. Partners with regional leaders and site teams to identify potential changes and opportunities for process improvement. Provide guidance, support, training and interpretation of regulations, guidelines, and policies Supports coordination of sponsor audits, regulatory inspections, and mock audits. Oversee documentation, reporting and closure of significant compliance and/or site review findings. Acts as backup Quality Manager for all sites within the network. Serve as the Quality Leader for assigned sites, providing direct hands-on support with quality reviews, audits/inspections, and CAPA resolution to reinforce site-level compliance and readiness. Facilitates New Hire Orientation and on boarding in collaboration with HR for clinical operations to specific functions related to quality. Develops and implements a mentorship program for new site employees to foster quality across the enterprise. Facilitates CTMS training in collaboration with ESource team. Requirements: Education - bachelors-degree in business or a health-related field required; master's degree preferred 5 years' + experience in clinical trials industry (sponsor or site) with experience in managing quality 3+ years' experience leading a team Experience with Quality oversight in Canada preferred but not required Prior experience authoring site SOP's preferred but not required Fundamental knowledge of US regulatory standards and guidelines for the conduct of clinical trials (ICH GCP, FDA; EMA; ANZ regulations) Ability to work in a remote setting with travel required sometimes with short notice Demonstrates strong analytical and proactive problem-solving skills Strong written and verbal communication skills Exceptional organizational skills, ability to multi-task and be detail oriented Experience developing and implementing training materials Accomplishes work in accordance with scheduled objectives and effectively meets deadlines Ability to maintain high degree of professionalism and integrity
    $116k-171k yearly est. Auto-Apply 5d ago
  • Quality Assurance-Control Manager

    NTI Connect LLC 3.8company rating

    Quality assurance manager job in Columbus, OH

    Job Description National Technologies (NTI), a Network Connex Company, is a premier turnkey installer of fiber optic and data center infrastructure. Working on our team puts you on the leading edge of innovation in the digital communications space. If being a part of a tight-knit organization that operates in some of the most advanced technology environments around the world sounds like a dream job, NTI might be the right fit for you! With the perks of a large organization, NTI remains true to its roots as a home-grown company with an open door culture that welcomes new ideas and encourages professional growth. We set you on the right path with careful onboarding and thorough training programs that prepare you for success in your role and beyond. Job Summary: As a Quality Assurance/Quality Control Manager, you will be responsible for managing the QA/QC Program for the Ohio market with the ability to travel to other markets and assist when necessary. This role involves developing and maintaining quality standards, performing inspections, managing quality-related documentation, and ensuring that all work complies with NTI standards. Job Duties and Responsibilities: Responsible for the start-up and implementation of the Quality Control Process. Interface directly with company and customers Quality Assurance (QA) and management on all quality related issues. Be technically experienced and capable of comprehending the specifications, standards, and code requirements for all assigned projects. Review all potential deficiency reports, track discrepancies, and verify the issues have been fully corrected prior to closure. Develop the Preparatory Meeting agendas, facilitate the Preparatory Meetings and participate in the Initial, Follow-up and Final Inspections. Be fully aware of the contract, plans, specifications, and applicable codes. Perform daily/weekly field inspections to verify employees work complies with the project specifications and applicable codes. Document and submit a Weekly Report of Quality Control activity. Perform material inspections to verify that the products are to specifications and that storage, staging and material handling methods are implemented. Audit quality control procedures. Work closely with the Health and Safety team to ensure a safe working environment for all employees and subcontractors. Provide hands-on coaching and feedback to the field technicians to reinforce quality standards. Identify reoccurring issues and collaborate on process improvements. Develop risk mitigation strategies to minimize project-related quality issues. Personnel evaluation and development for QA/QC team. Job Knowledge, Skills, and Abilities: Excellent verbal and written communication skills. Excellent organizational skills and attention to detail. Excellent time management skills with a proven ability to meet deadlines. Strong analytical and problem-solving skills. Ability to prioritize tasks and delegate them when appropriate. Excellent leadership skills. Proficiency in relevant software tools and quality control systems. Strong commitment to safety and quality. Proficient with Microsoft Office Suite or related software. Education and Experience: Certification in Quality Assurance or Quality Control is a plus. Proven experience in QA/QC roles within the industry, with a minimum of 4 years of experience. Strong knowledge of codes, standards, and regulations. Physical Requirements: Must be able to carry and lift items weighing up to 25 pounds. Pay rates may vary based on skills, background, experience and specific location. NTI provides a comprehensive benefits package including health, dental, vision, life, and disability insurance and retirement savings options. For Union employees, pay rates and benefit levels are determined by union classifications which are set by the union. National Technologies (NTI) believes all persons are entitled to equal employment opportunities and does not discriminate against employees or job applicants because of race, color, gender, affectional or sexual orientation, domestic partnership status, ancestry, religion, national origin, citizenship status, marital status, disability, veteran status, age or any other protected group status. Upon acceptance of an offer, all candidates will be required to pass a background check and drug screening.
    $71k-102k yearly est. 11d ago
  • Grants Quality Assurance/Compliance Manager

    Tumeq LLC

    Remote quality assurance manager job

    MIPPS is seeking a mission-driven Grants Quality Assurance/Compliance Manager to join our team. In this senior support and partnering role, you will work alongside Federal staff on a robust portfolio of both grants and cooperative agreements that support agriculture, particularly local and regional food systems and increasing consumer access to fresh, healthy foods throughout the United States. The Quality Control Manager plays a critical role in ensuring compliance with federal grant regulations, agency-specific policies, and related oversight requirements. This position supports the development and implementation of internal quality assurance systems, conducts compliance audits, and provides technical assistance related to program integrity, with a risk-based approach. This is a critical senior position and functions to maintain and enhance the capacity of our grants program monitoring and oversight functions. The ideal candidate brings expertise in federal grants, internal auditing and controls, regulatory compliance, and risk management in helping to safeguard public resources from fraud, waste, and/or abuse and to enhance operational performance. This is a remote position and reports to the contract Program Manager and indirectly to the Federal Program Director. ESSENTIAL DUTIES AND RESPONSIBILITIES Quality Control and Assurance: Independently and/or in partnership with colleagues, conducts compliance auditing activities reflecting any/all components of the grant's life cycle from pre- to post-award. The individual often serves as the “second line of defense” regarding internal controls that address risks and issues facing the organization, particularly on contractor deliverables, and in support of federal staff deliverables. Work includes internal reviews, root cause analyses, forensic auditing, and providing recommendations on corrective actions to Federal partners, as well as enhancing current systems and approaches that monitor and assess programmatic and operational quality. Internal Controls and Risk Management: Supports and advances the Programs' risk-based approach to mitigate the likelihood and impact of compliance and fraud risks inherent in federal grantmaking. Includes assessing and prioritizing program and project risks with Federal partners; enhancing current anti-fraud, waste, and abuse internal controls; supporting risk indicator development and use; and similar. Includes enhancing financial and administrative internal controls policies, procedures, and reviews to support Federal partners on resolution of audit findings and when necessary, investigations. Training and Internal Technical Assistance : Develops and delivers training and guidance to colleagues on federal compliance, audit readiness, internal controls, quality standards, and similar. Serves as a resource for interpreting regulatory language and applying compliance best practices. Provides assistance to Federal partners on proper maintenance of policy and procedure documentation; on developing and monitoring corrective actions; and on reports and dashboards for leadership. QUALIFICATIONS CLEARANCE REQUIREMENTS Must receive a favorable background check. Must be able to obtain and maintain a Public Trust or Security Clearance. Click link below to review Public Trust requirements: *************************************************************************************************** REQUIRED EXPERIENCE Minimum of 5 years of experience in internal controls, compliance auditing, and risk management, preferably in a federal grants management environment. Minimum of 5 years of experience with federal compliance activities in grants management, and/or quality controls/assurance, including strong knowledge of 7 CFR Part 200, federal auditing standards, and applicable laws and regulations. DESIRABLE EXPERIENCE Certification in Internal Auditing (CIA), or a Certified Public Accountant (CPA). Ability to obtain and maintain high Public Trust-level clearance. Hands-on experience with forensic audit and data analytics tools (e.g., ACL, IDEA, TeamMate). Demonstrated expertise applying GAO's Generally Accepted Government Auditing Standards (Yellow Book) and Standards for Internal Control in the Federal Government (Green Book) to strengthen audit quality and internal control frameworks. SKILLS Demonstrated skills and knowledge related to grants management as defined by laws, rules, policies, procedures, and methods governing the administration of Federal grants and cooperative agreements. Comfortable working independently to plan, consult on, and prioritize workload and manage and track multiple projects and deadlines simultaneously. Strong problem-solving, critical thinking, organizational, communication, and analytical abilities; attention to detail; and flexibility and judgment related to serving in an internal audit function. Proficiency with Microsoft Office applications as well as forensic audit tools, data systems, and reporting dashboards. DEGREE REQUIREMENT: Bachelor's degree in business administration, Finance, Accounting, Law, Public Administration, or a related field. A master's degree is preferred. Work Environment: Remote work environment, with occasional travel required to field offices or partner sites as needed. US Citizenship Required Benefits Include: 401(K) Plan with Employer Match, Health Insurance (medical, dental, and vision), Paid PTO, Flexible Spending Accounts (Health and Dependent Care), Life insurance, short term and long-term disability, Full Holiday Schedule and more. This company, its subsidiaries, and joint ventures will provide equal employment opportunities to all persons and prohibits employment decisions based on race, religion, color, creed, national origin, sex, age, disabling condition, political affiliation, protected veteran's status, or sexual orientation. All selection, hiring, and promotion decisions will be based on valid job-related requirements consistent with performance of the essential functions of the position. This policy is in keeping with Executive Order 11246, as amended, Title IX of the Education Amendments of 1972, the Equal Pay Act of 1963, Sections 503 and 504 of the Rehabilitation Act of 1973, the Civil Rights Restoration Act of 1988, the Vietnam Veterans Readjustment Assistance Acts, as amended, and other applicable federal and state laws. Pursuant to PL 93-638, as amended, preference may be given qualified to the Corporation's Shareholders, including their spouses and descendants, during the hiring process to the maximum extent permitted by law.
    $79k-117k yearly est. Auto-Apply 7d ago
  • Manager, Quality and Manufacturing

    Hello Heart 3.9company rating

    Remote quality assurance manager job

    Hello Heart is on a mission to change the way people care for their hearts. The company provides the first app and connected heart monitor to help people track and manage their heart health. With Hello Heart, users take steps to control their risk of heart attacks and stroke - the leading cause of death in the United States. Peer-reviewed studies have shown that high-risk users of Hello Heart have seen meaningful drops in blood pressure, cholesterol and even weight. Recognized as the digital leader in preventive heart health, Hello Heart is trusted by more than 130 leading Fortune 500 and government employers, national health plans, and labor organizations. Founded in 2013, Hello Heart has raised more than $138 million from top venture firms and is a best-in-class solution on the American Heart Association's Innovators' Network and CVS Health Point Solutions Management platform. Visit ****************** for more information. About the Role: As Manager, Quality and Manufacturing, you will own both quality engineering and manufacturing engineering functions for our hardware products. You will ensure production readiness, product quality, process capability, and smooth issue resolution from prototype through mass production. Reporting into our Senior Director, Product and Manufacturing Operations, you will collaborate closely with suppliers, engineering, program management, and operations teams. You will create the structure, tools, and processes that enable consistent, high-quality manufacturing outcomes. Responsibilities Validate manufacturing readiness for NPI builds, including tools, fixtures, process flow, and documentation Partner with engineering teams on DFM and DFA reviews, qualification testing, and readiness milestones Create and maintain quality control plans across IQC, IPQC, and OQC processes Define and implement manufacturing process controls, test requirements, and build validation plan Lead structured root cause analysis using 8D, 5 Why, and Fishbone methodologies Drive corrective and preventive actions and verify long-term effectiveness Conduct line audits, capability studies (Cp and Cpk), and SPC monitoring to assess process health Monitor yields, reduce defects, and drive continuous improvement across production lines Assess supplier capability and lead onsite production reviews and factory evaluations Define incoming inspection criteria, sampling plans, and supplier quality alignment Maintain detailed build documentation, quality dashboards, and audit reports Qualifications 7+ years of experience in quality engineering, manufacturing engineering, or a related hardware-focused discipline Hands-on experience with production lines, fixtures, test equipment, and hardware manufacturing processes Strong understanding of quality systems including ISO 9001, ISO 13485, PFMEA, SPC, and Six Sigma Proven experience leading root cause analysis and driving corrective actions Experience working with contract manufacturers and suppliers, preferably in Asia Strong analytical skills with the ability to interpret yield trends, SPC data, capability studies, and defect data Excellent communication skills with the ability to present findings and recommendations Experience supporting NPI builds and high-volume product ramp is preferred Familiarity with reliability testing and environmental qualification is preferred Knowledge of hardware system integration spanning mechanical and electrical components is preferred Experience with DOE, process optimization, or Lean Manufacturing is preferred Mandarin language proficiency is a plus The US base salary range for this full-time position is $140,000.00 to $160,000.00. Salary ranges are determined by role and level. Compensation is determined by additional factors, including job-related skills, experience, and relevant education or training. Please note that the compensation details listed in US role postings reflect the salary only, and do not include equity or benefits. Hello Heart has a positive, diverse, and supportive culture - we look for people who are collaborative, creative, and courageous. Oh, and if you want to see some recent evidence of the fun things we do at Hello Heart, check out our Instagram page.
    $140k-160k yearly Auto-Apply 34d ago
  • QA Release Sr. Manager

    American Regent 4.7company rating

    Quality assurance manager job in New Albany, OH

    Nature and Scope Reporting to the, QA Operations & Quality Systems Director, the QA Release Senior Manager focuses on final release of all components, materials, and products utilized and produced at American Regent sterile manufacturing plants and laboratories. This position is also responsible for oversight of activities of Contract Manufacturing Organizations (CMO) finished product manufacturing and their adherence to established Quality and Compliance requirements. This is a multi-disciplinary management role that will interact with all phases of production including manufacture of sterile injectables, laboratories, facilities/engineering, and materials at three different American Regent sites in the Columbus, Ohio area. Essential Duties and Responsibilities Nothing in this job description restricts management's right to assign or reassign duties and responsibilities to this job at any time. Perform all duties in accordance with American Regent and Daiichi Sankyo Business Principles, corporate directives, SOPs, policies, and government and industry regulatory guidelines. Manage and assign QA staff in incoming, in-process, final inspection, and batch release. Includes the inspection & sampling of raw materials, finished products, and components. Is directly responsible for batch releases. Oversee GMP activities of Contract Manufacturing Organizations (CMO) finished product manufacturing and ensuring conformance to established Quality and Compliance requirements. Ensures oversight for the successful life cycle development and commercialization of pharmaceuticals at external manufacturing partners. Act as a liaison between QA and other departments on quality issues related to release of incoming, in-process, and final products and report back to the QA Operations & Quality Systems Director. Initiation, review and approval of cGMP documentation including: procedures, policies, change controls, deviations. Develop and manage quality metrics to optimize performance, identify trends, and communicate to Senior level Management. Identify quality process improvements to increase efficiencies and performance of systems, operations and personnel. Identifies and resolves potential cGMP issues which may impact quality and reports results to Senior level Management. Consistently demonstrate QUALITY culture and behaviors and perform all duties in accordance with American Regent and Daiichi Sankyo Business Principles, corporate directives, SOPs, policies, and government and industry regulatory guidelines. Ensures all work is performed and documented in accordance with existing Company policies and procedures, as well as cGMP and health and safety requirements in the markets where product is sold. Ensures Quality Assurance goals and objectives are identified and met Act as a liaison between American Regent QA and third-parties on quality issues and report back to the QA Operations & Quality Systems Director Provide effective leadership including: individual goal setting/performance reviews, managing the development of employees, recognizing and appreciating employee contributions, mitigating conflict and communication problems, planning and facilitating team activities, selecting personnel and motivating members of the functional area. Perform any other tasks/duties as assigned by management. Education Requirements and Qualifications To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill and/or ability required. Bachelors' degree in Life Science or equivalent course of study is required. 10 years progressive experience in QA Pharmaceutical environment required. 5-10 years management experience required. Strong working knowledge of Federal (FDA) Good Manufacturing Practice (GMP) requirements and guidelines and documentation practices. Excellent oral and written communication skills including strong technical writing skills. Strong organizational skills, planning skills and team-building. Ability to work independently and deliver timely results. Ability to lead cross functional teams, resolve conflicts and disagreements. Ability to travel between each of the Ohio facilities (in the greater Columbus area). American Regent celebrates diversity and we are committed to creating an inclusive environment for all employees. We are an Equal Opportunity Employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability status, or protected veteran status. Applicants have rights under Federal Employment Laws. FMLA poster: ********************************************************** Know Your Rights: Know Your Rights: Workplace discrimination is illegal (eeoc.gov) Employee Polygraph Protection Act: ********************************************************* Alert: We're aware of individuals impersonating our staff to target job seekers. Please note: · All legitimate communication will come directly from a verified ARI recruiter either by phone or via an americanregent.com email address. · Our recruiting process includes multiple in person and/or video interviews and assessments. · If you are unsure about the legitimacy of a message, contact John Rossini at *************************** before responding. · We never request payment, bank information, or personal financial details during our offer process. Your security is important to us, and we encourage you to stay vigilant when job searching. American Regent Inc. endeavors to make *********************************** accessible to any and all users. If you would like to contact us regarding the accessibility of our website or need assistance completing the application process, please email **************************************.
    $69k-96k yearly est. Auto-Apply 60d+ ago
  • Technical QA Lead/ QA Manager (40107)

    Idealforce

    Quality assurance manager job in Columbus, OH

    IDEALFORCE has a CONTRACT position available immediately for a Technical QA Lead/ QA Manager to join our customer in Columbus, OH. This is an ONSITE position. Please find below additional details about this job. Hiring Manager would like to have all qualified candidates interview face to face. Only LOCAL CANDIDATES are considered for this role. Job Description The Product Specialist will be serving in a Technical Quality Assurance Lead role. This role will focus on but not be limited to managing the testing of interfaces both between internal systems and with external partners. The responsibilities will range from managing the business functional as well as the IT technical testing and coordination of all involved parties. A strong testing background is critical and a background in interface design and development is very beneficial. Qualifications • Four year college degree or equivalent technical study • 7-8 years of QA experience • Impact analyses on production fixes and enhancements to establish priorities. • Provide basic product support and provide accurate and complete answers to detailed product questions in a timely manner. • Provide effective on-site product support as needed. • Accurately set severity of identified defects. • Provide input to training and / or documentation materials regarding latest technical and functional design changes. • Review the system test approach and conditions used as the basis for detailed test scenarios. • Follow quality standards. • Analytical and customer service skills. • Strong communication skills; both written and spoken • Effectively lead product tests and trials. • Identify appropriate business examples to illustrate key concepts / features. • Anticipate, identify, track and resolve issues and risks affecting own work and work of the Application Team. Develop contingency plans as necessary. • Apply specific expertise to ensure that products meet defined customer objectives. • Determine time estimates and schedule for own work and resolve issues in a timely manner. • Identify and track issues, risks and action items. • Demonstrate expertise in teaching / conveying technical and / or functional courses / concepts. • Develop appropriate work programs / budgets and use to effectively schedule tasks / assignments. • Identify improvements to project standards to achieve high quality services / products. • Interact with executive level business users or technical experts. • May function as a niche SME. This position is specifically focused on the Core Project as a Test Lead with a focus on Interfaces (BWC and External). Experience with User Acceptance Testing with external partners is preferred. • Experience with TFS (Microsoft Team Foundation Server), MS Visual Studio, MTM (Microsoft Test Manager) is a preferred. • Microsoft Office Desired • Make sound recommendations on functional and technical improvements to the product. • Analyze the functional and technical impact of product planning decisions. • Develop appropriate functional and usability standards for products. • Track and document expected volume and type of use of the product. • Participate in product design reviews to verify that design meets quality standards and functional/technical requirements. • Actively contribute as an expert or actual designer. • Coordinate product design reviews to verify that design meets quality standards and functional/technical requirements. • Provide accurate estimates for design and programming efforts for system changes and enhancements. • Coordinate enhancements to business and logical data models with data base administration to make the appropriate changes to the physical data model. • Confirm that technical architecture will support all changes required by product enhancements. Additional Information THIRD PARTY CANDIDATES: Email your candidate/s resume to joseph dot shelton at idealforce.com along with the following details: Rate, Current location and Availability. Disclaimer : The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified. All personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed.
    $88k-118k yearly est. 60d+ ago
  • Quality Manager

    Heart of Ohio Family Hea Lth Centers 3.0company rating

    Quality assurance manager job in Columbus, OH

    The primary function of the Quality Program Manager is responsible for providing day to day management of the quality improvement program. Responsible for coordinating activities of quality department staff, suggesting process changes, measuring data, and completing QA activities to achieve organization goals for quality measures for programs like UDS, Accountable Care/Clinically Integrated Networks, Ohio Medicaid CPC, CPC Kids, CMC, and individual insurance plan contracts. Reports to: Director of Quality and Clinical Systems Supervises: Yes Dress Requirement: Business Casual Work Schedule: Monday through Friday during standard business hours Times are subject to change due to business necessity Exempt Essential Job Duties and Responsibilities Work with supervisor and members of clinical leadership to develop, implement, monitor, and measure plans to improve processes and quality outcomes. Work with supervisor, clinical leadership, data analytics team, and external data vendor Unity PHM to analyze data, clean data, and perform quality assurance activities. In collaboration with supervisor, Chief Medical Officer, and others, the position is responsible for carrying out system-wide quality programs. Assists with developing, planning, and implementing policies and procedures. Works closely with supervisors, clinical teams, and non-clinical teams for quality improvement efforts. Assists with designing processes for quality improvement purposes. Plays a key role in maximizing revenue from value-based care, pay-for-performance, and risk adjustment contracts. Ensure compliances with program requirements. Examples include individual insurance plan contracts, Accountable Care/Clinically Integrated Networks, Ohio Medicaid CPC, CPC Kids, and CMC programs. Focuses on better healthcare value and quality, including the improvement of clinical outcomes, patient experience, patient safety, costs, revenue, productivity, efficiency, employee and physician satisfaction, and process reliability. Leads or participates in meetings related to quality improvement. Coordinate, manage and report UDS measures and other data related to clinical quality. Manages performance improvement projects to assure milestones and key performance indicators are met within defined parameters. Documents the results of projects, and submits other documentation as requested. Develop and motivate department staff. Interview, monitor time and attendance, and manage performance of subordinates. Report on clinical quality measures internally and externally. Provide updates to internal and external stakeholders on progress in quality initiatives. Support data collection and reporting related to grants. This job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee. Duties, responsibilities and activities may change or new ones may be assigned at any time with or without notice. Qualifications Education: Bachelor's degree in a related field required. Examples include nursing, healthcare administration, public health, or similar. Certifications such as CPHQ and Lean Six Sigma are beneficial, but not required. Experience: At least four years of experience in the healthcare field, quality, data analytics, and/or management strongly preferred. Master's level education and appropriate background may substitute for some experience. Knowledge of clinical operations including the functions of the front and back-office utilization information systems is preferred. Previous experience working in an outpatient clinic is preferred. Knowledge/Abilities: Excellent communication skills, both written and verbal, are required. Strong organization and time management skills are required. Ability to work independently and demonstrate initiative is required. Proficiency with Microsoft Office is required. Displays cheerful demeanor and makes positive comments when on duty. Works cooperatively with other staff members. Displays sensitivity in a multi-cultural environment. General understanding of the medical billing process is preferred. Equipment Operated : Telephone Computer Printer Fax machine Copier Other office equipment as assigned Other office and medical equipment as assigned Facility Environment : Heart of Ohio Family Health operates in multiple locations, in Columbus, OH. All facilities have a medical office environment with front-desk reception area, separate patient examination rooms, nursing stations, pharmacy stock room, business offices, hallways and private toilet facilities. All facilities are ADA compliant. The patient examination rooms and office area is: kept at a normal working temperature sanitized daily maintains standard office environment furniture with adjustable chairs maintains standard office equipment; i.e., computer, copier, fax machine, etc. at a normal working height Physical Demands and Requirements : these may be modified to accurately perform the essential functions of the position: Mobility = ability to easily move without assistance Bending = occasional bending from the waist and knees Reaching = occasional reaching no higher than normal arm stretch Lifting/Carry = ability to lift and carry a normal stack of documents and/or files Pushing/Pulling = ability to push or pull a normal office environment Dexterity = ability to handle and/or grasp, use a keyboard, calculator, and other office equipment accurately and quickly Hearing = ability to accurately hear and react to the normal tone of a person's voice Visual = ability to safely and accurately see and react to factors and objects in a normal setting Speaking = ability to pronounce words clearly to be understood by another individual
    $69k-90k yearly est. Auto-Apply 60d+ ago
  • QA/QC Manager

    Blackrock Resources 4.4company rating

    Quality assurance manager job in New Albany, OH

    You must be able to work in the U.S. without sponsorship. No C2C or 3rd parties, please. We're hiring an experienced QA/QC Manager to support a greenfield data center construction project in New Albany, OH. This is a high-impact role for someone who understands the complexity of electrical installations and thrives in a detail-driven, fast-paced construction environment. This is an on-site role focused on maintaining and overseeing all aspects of the project's quality assurance and control plan. You'll report directly to the Project Manager and coordinate with on-site and off-site teams, subcontractors, and stakeholders to ensure compliance, safety, and precision across the board. Key Requirements: * Hands-on experience with high voltage electrical projects * Strong command of construction quality regulations * Exceptional attention to detail and documentation * Ability to communicate effectively with all levels - from tradespeople to leadership * Previous experience in greenfield or data center construction strongly preferred * Skilled in electrical inspections, walk-downs, and system testing * Comfortable with tools like Excel, Word, and QA documentation systems What You'll Be Doing: * Implement and manage the project's QA/QC plan * Oversee subcontractor compliance and coordinate inspections * Lead documentation processes - from submittals and logs to final as-builts * Conduct walk-downs, material tracking, shop drawing reviews, and 4-phase inspections * Maintain testing records, rework lists, and support third-party audits * Actively ensure the project stays on track, safe, and within quality specs Additional Info: * Must be able to read and interpret blueprints, specs, and system documentation * Prior work with systems like CSA, CX mapping, Bus Duct, Cable Bus, and MV/LV gear * Physical ability to move around large construction sites and wear PPE daily * 15+ years in QA/QC for heavy industrial construction preferred If you're someone who takes pride in doing it right the first time, keeps quality at the forefront, and is ready for a major project, please send your resume to Brandon at bgreen@blackrockres.com. #LI-DNI
    $75k-98k yearly est. 23d ago
  • Senior Food Safety & Quality Program Manager

    Versova

    Quality assurance manager job in Johnstown, OH

    Job Title: Senior Food Safety and Quality Program Manager Department: Compliance Reports To: Senior Director of Compliance Job Type: Full Time Travel: 20%-30% Compensation: starting salary $90,000-$111,000 based on experience Job Summary The Senior Food Safety and Quality Program Manager supports the development, coordination, and continuous improvement of food safety and quality programs across all Versova food processing and feed manufacturing facilities. This role helps ensure compliance with federal, state, and local regulations, as well as customer, third-party, and industry standards, using HACCP, GMP, and other recognized methodologies. The Senior Food Safety and Quality Program Manager partners closely with local Food Safety and Compliance Teams, Operations, Feed Mill Management, and Human Resources to maintain programs that protect product integrity, reduce food safety risks, and support successful audit outcomes. Essential Job Functions Develop, implement, and maintain food safety and quality programs that meet company, federal, state, customer, and third-party standards (FDA, USDA, SQF, state regulators, etc.). Coordinate and support food safety training, creating clear and easy-to-understand materials for employees and compliance teams. Monitor sanitation practices and help ensure processes are followed to reduce food safety risks. Conduct internal audits, gap assessments, and routine program reviews; document findings and support corrective actions. Assist sites and local food safety teams with preparation for external audits and inspections and communicate audit expectations. Maintain accurate documentation, ensure programs remain current with regulatory and customer requirements, and track food safety KPIs and trending data. Review food safety data with compliance and operations teams to identify opportunities for improvement in GMPs, product holds, validations, and other key processes. Support investigations of customer complaints, nonconformities, and risk assessments; recommend and implement program modifications. Oversees traceability program, third party portals and audits for co-op marketing purposes as it relates to identity preserved certifications (i.e. UEP, etc.). Partner with feed mills to develop and monitor feed safety programs, ensuring compliance with applicable regulations. Serve as a contact for customer and regulatory communications related to food safety and quality and help maintain productive relationships with USDA/FSIS, FDA, and state agencies. Other duties as assigned Required Qualifications Bachelor's degree in Food Science or a related field (or equivalent experience). 4+ years of related experience in food safety, compliance, manufacturing, or quality assurance. Understanding of HACCP, GMP, and applicable food safety regulations. HACCP certification (or ability to obtain). Strong written and verbal communication skills in English. Proficiency with Microsoft Office and general documentation tools. Preferred Qualifications Experience supporting internal or external food safety audits. Knowledge of feed safety programs and/or agricultural production environments. Familiarity with SQF, FDA, USDA, and state regulatory requirements. Ability to collaborate effectively across multiple sites and teams. Work Environment This role requires routine travel. Work may occur in both office and food/feed manufacturing environments with exposure to varying temperatures, dust, and typical plant conditions. Physical requirements include the ability to walk, stand, and sit for extended periods, conduct on-site assessments, and navigate production areas safely. The position requires adaptability and the ability to support multiple food safety priorities across different locations. About Us: Versova is one of the largest egg producers in the United States, bringing together family-owned farms in Iowa, Ohio, Washington, Oregon, Idaho, Utah, and Colorado. With over six decades of industry experience, our team of more than 2,000 employees is dedicated to exceptional flock care, environmental stewardship, and producing safe, high-quality eggs. More than just a workplace, Versova is a team built on shared values, working together to enrich our communities and uphold the highest ethical standards. As a family of companies and a company of families, we are guided by a strong set of Core Values: Recognition, Initiative, Safety & Security, Service, Community, Respect, Integrity, Ownership, and Excellence. These values drive our commitment to responsible employment, sustainability, and industry innovation. When you join Versova, you become part of something bigger - working together to lead the future of egg production with integrity and excellence. Benefits: Regular performance reviews Health insurance Dental insurance Vision insurance HSA with company match Paid time Off Paid Holidays 401K with company match Tuition Reimbursement Employee Assistance Program Posting Statement All qualified applicants will receive consideration for employment without regard to race, color, religion, religious creed, sex, national origin, ancestry, age, physical or mental disability, medical condition, genetic information, military and veteran status, marital status, pregnancy, gender, gender expression, gender identity, sexual orientation, or any other characteristic protected by local law, regulation, or ordinance. Disclosure This job description is not exhaustive, as employees may perform additional related duties as needed. Employment is based on an 'at-will' basis. Employment is contingent upon the successful completion of a background check, as applicable to the role and in compliance with local, state, and federal laws
    $90k-111k yearly 20h ago

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