Quality assurance manager jobs in Johnson City, TN - 30 jobs

Premium Waters is looking to add a Quality Assurance Lead to carry out our company mission of maintaining an inclusive culture of trust, honesty, humility, integrity, and candor in our dealings with others, ourselves, and our communities. Who are we? Premium Waters is the 2nd largest bottler of private label bottled water products in the U.S.A. We are committed to providing high quality bottled water in an environmentally friendly manner. Our Teams focus on proactively supporting safety, understanding sustainability, and building lasting relationships. Your part in our story: The QA Team Leader's main responsibility lies in the water processing. The QA Lead insures that the water specifications are correct for each product produced, from the beginning to the end. They tend all the tanks in the plant, spring, and process room. Continuously throughout the production run they perform microbiological testing on the finished product to ensure its quality. QA Team Leader must follow all HACCP and SQF regulations. Qualifications: Undergraduate degree in chemistry or science preferred, but will accept experience in lieu of education. Minimum of two years work-related experience or training preferred. Ability to work a flexible schedule as needed. Basic reading, writing, and math skills. Basic computer knowledge of Microsoft Word and Excel. Computer experience is required. Reports to Production Manager and Blow Mold Lead. This position may work with little supervision. Forklift certification (Must complete certification within 90 days of hire.) GMP & PPE Required: While on the production floor in the plant you will be required to follow and help to enforce all GMP regulations in the plant. Anyone entering the production floor must follow the GMP rules in their employee handbook, which includes the required hairnets, beard nets, and earplugs. It is also required that all personnel wear safety glasses. Follows standard operating procedures including quality checks and procedures for all operations. Also follows HACCP and SQF requirements for food quality and safety. Essential Job Duties: Oversee all plant regulatory testing. Participation and preparation for all plant audits. Assist with completing GMP audits, customer complaint investigations, and Mock recall and traceability exercises. Performs daily and quarterly micro tests (coliform, HPC, yeast/mold, etc.) Oversee maintenance of all water processing related equipment. Must be able to work off-shifts as needed. Assist with resolution of non-conformances and corrective actions. Monitor all areas of the plant for GMP compliance. Makes sure that all personnel are adhering to corporate GMP policies Monitor all lab supply kanbans regularly. Weekly collection of outside lab samples Function as a training resource to the plant. Fills in for Quality Technicians and the Quality Assurance Manager as needed. Manages QA documents. Follows standard operating procedures. Lead and Coach the team to follow the company's Mission, Values and Ethics Non-Essential Job Duties Will perform other related work as assigned by the Manager. In the absence of this employee, the direct manager or appointee will cover responsibilities. 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 job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Sitting - Approximately 35% of the time Standing - Approximately 40% of the time Walking - Approximately 25% of the time Bending/stooping - Occasionally Crouching - Occasionally Pushing/Pulling - Occasionally Lifting/Carrying up to 50 lbs - Frequently Verbal communications - Constantly Written communications - Frequently Hearing normal conversation - Frequently Sight, including near acuity and dept perception - Frequently

Apply now " Company: Dentsply Sirona, Inc Dentsply Sirona is the world's largest manufacturer of professional dental products and technologies, with a 130-year history of innovation and service to the dental industry and patients worldwide. Dentsply Sirona develops, manufactures, and markets a comprehensive solutions offering including dental and oral health products as well as other consumable medical devices under a strong portfolio of world class brands. Dentsply Sirona's products provide innovative, high-quality and effective solutions to advance patient care and deliver better and safer dentistry. Dentsply Sirona's global headquarters is located in Charlotte, North Carolina. The company's shares are listed in the United States on NASDAQ under the symbol XRAY. This position is located in Tulsa OK, in the heart of Green Country in Northeast Oklahoma, the city of Tulsa is the 2nd largest city in Oklahoma and prides itself on its growing economy, beautiful recreational and scenic destinations, and cultural attractions. Tulsa is a flourishing city with the friendliness and close-knit attitude of a much smaller town. Among the city's many advantages are choices of a variety of schools, businesses, museums, shopping centers, universities and cultural hotspots, making Tulsa a great place to live, work and raise a family! Bringing out the best in people As advanced as dentistry is today, we are dedicated to making it even better. Our people have a passion for innovation and are committed to applying it to improve dental care. We live and breathe high performance, working as one global team, bringing out the best in each other for the benefit of dental patients, and the professionals who serve them. If you want to grow and develop as a part of a team that is shaping an industry, then we're looking for the best to join us. Working at Dentsply Sirona you are able to: Develop faster - with our commitment to the best professional development. Perform better - as part of a high-performance, empowering culture. Shape an industry - with a market leader that continues to drive innovation. Make a difference -by helping improve oral health worldwide. We are seeking a Quality Assurance Manager to lead our Quality team at the Johnson City site. This is a high-impact role where you will serve as the Site's Management Representative and the Person Responsible for Regulatory Compliance (PRRC) under EU MDR 2017/745. What You'll Do: * Lead QA, QE, QC, and Post-Market Surveillance teams, overseeing all QMS activities defined in the quality manual. * Ensure compliance with FDA, ISO 13485, MDSAP, EU MDR and other applicable global medical device standards and regulations. * Provide oversight of sterile medical device manufacturing, including sterilization validation, monitoring, and routine controls. * Manage and support validations and controls in alignment with ISO 11137 (sterilization of healthcare products - radiation) and ISO 11737 (bioburden, sterility testing, endotoxins). * Represent the site in audits, inspections, and top management reviews. * Drive the CAPA process, risk management activities, and continuous improvement of quality systems. * Promote regulatory awareness and provide training across the organization. * Collaborate with R&D, Manufacturing, and RA to ensure quality and compliance across the product lifecycle. What We're Looking For: ️ 5+ years of proven experience in Quality Management within the medical device industry ️ Strong knowledge of sterile medical device requirements and sterilization validations (ISO 11137 / ISO 11737 series) ️ Solid background in ISO 13485, FDA QSR, MDSAP, and EU MDR requirements ️ Leadership skills to guide and grow cross-functional quality teams ️ Hands-on experience with CAPA, audits, and risk management Dentsply Sirona is an Equal Opportunity/ Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, age, sexual orientation, disability, or protected Veteran status. We appreciate your interest in Dentsply Sirona. If you need assistance with completing the online application due to a disability, please send an accommodation request to **************************. Please be sure to include "Accommodation Request" in the subject. For California Residents: We may collect the following categories of personal information in connection with the submission of your resume or application materials to us for employment, and if hired, your employment with us: identifiers (e.g., name, address, email address, birthdate); personal records (e.g., telephone number, signature, education information, criminal background information, passport number and visa information); consumer characteristics (e.g., sex, marital status, veteran status, race, disability, sexual orientation); professional or employment information (e.g., resume, cover letter, employment history, background check forms, references, certifications, transcripts and languages spoken); and inferences from personal information collected (e.g., a profile reflecting abilities and aptitudes). The above categories of personal information are collected for the following business purposes: performing recruitment and hiring services; processing interactions and transactions (e.g., to comply with federal and state laws requiring us to maintain certain records, managing the workforce); and security (e.g., detecting security incidents, protecting against fraudulent or illegal activity). For additional details and questions, contact us at **************************

Our award-winning client is seeking a Quality Manager to join their team. Our award-winning global leader in high-performance battery separators seeks a passionate Quality Manager to join their team. Responsibilities: Spearhead IATF 16949 certification for our lithium-ion battery separator expansion project, ensuring the highest quality standards. Maintain company accreditations (ISO 9001, IATF 16949), guaranteeing compliance and exceeding industry benchmarks. Lead internal and customer quality audits to identify and address any potential issues. Champion continuous improvement by managing internal QMS audits and layered process audits. Develop and refine quality management system processes for optimal efficiency. Report key performance indicators (KPIs) to senior management, providing actionable insights. Foster a culture of quality awareness by effectively communicating customer requirements throughout the organization. Required Qualifications: A bachelor's degree in a relevant field is required. (e.g., Engineering, Quality Management). 5+ years of experience with IATF 16949 Quality Management Systems. Project management experience in the battery industry is a plus. IATF certification auditor certification preferred. Strong communication, collaboration, and customer service skills. Experience working across departments (Sales, R&D, Operations). Excellent written, verbal, and listening skills. Ability to work independently and manage multiple priorities.

Job Title: Quality Assurance Manager Work Location: OK/TN Department: Quality Reports To: Plant Manager Direct Reports: Quality Technicians / Inspectors FLSA: Exempt Wage Type: Annual Salary (DOE) The Quality Assurance Manager is responsible for overseeing the quality assurance and control functions within the HDPE manufacturing facility. This role ensures compliance with ISO, ASTM, AWWA, UL, and other applicable standards, while driving continuous improvement and operational excellence across all quality processes. The incumbent leads testing, inspection, and auditing programs to maintain the highest quality of materials and finished products. Key Responsibilities Quality Assurance & Compliance · Develop, implement, and maintain a Quality Management System (QMS) compliant with ISO 9001 and applicable regulatory standards. · Ensure all products meet customer, company, and industry specifications (ISO, ASTM, AWWA, FM, UL, etc.). · Conduct internal audits, support external audits, and coordinate certification renewals. · Manage product inspection, data collection, and disposition of on-hold materials. · Participate in customer and regulatory audits, addressing findings in a timely manner. · Review and update QA documentation (QTs, SQPs, L4 documents) and support periodic reviews. Inspection & Testing · Oversee incoming inspection of PE resin and additives to ensure conformity to specifications. · Supervise in-process and final product inspections (dimensional checks, hydrostatic pressure, tensile, and impact testing). · Analyze test data to identify trends and initiate corrective/preventive actions (CAPA). · Maintain calibration of gauges and testing instruments; manage gauge inventory and database accuracy. Process Control & Continuous Improvement · Partner with Production to monitor extrusion processes and critical control points. · Establish and maintain Standard Operating Procedures (SOPs) and work instructions. · Drive Lean and continuous improvement initiatives to reduce scrap, rework, and complaints. · Actively participate in 5S, BIQC, and preventive quality initiatives. Leadership & Training · Lead and develop the QA team to achieve department and plant objectives. · Deliver training on quality systems, defect identification, testing methods, and safety. · Promote a culture of accountability, learning, and teamwork within the plant. · Support Health & Safety initiatives and ensure adherence to PPE and safety standards. Customer & Supplier Relations · Manage customer complaints through structured root cause analysis and CAPA implementation. · Collaborate with suppliers to maintain material quality and support continuous improvement. · Provide technical support to customers on product performance and application. Qualifications · Minimum 5 years of QA/QC experience in HDPE or plastic manufacturing. · Strong understanding of HDPE extrusion, molding, and pipe testing methods. · Proficiency in quality tools (root cause analysis, CAPA, statistical analysis). · Knowledge of ISO, ASTM, UL, FM, and AWWA standards. · Experience with ERP systems and MS Office Suite. · Lean or Six Sigma certification preferred. · Strong leadership, communication, and problem-solving skills.

Do you have 10 to 15 years of progressive experience in quality assurance or quality control, especially on design-build transportation projects? MBP is looking for a Quality Assurance Manager to join our team. If you have extensive experience in quality assurance/quality control and a background in transportation construction, design, engineering consulting, or project management, we encourage you to apply. This role offers opportunities for professional growth and career advancement. Responsibilities What You'll Do: Act as on-site client representation for mid-to-large projects. Develop and maintain Quality Management System (QMS) Conduct site visits and propose engineering solutions Lead and conduct internal and external quality audits of projects and processes, ensuring compliance with specifications, regulations, and company standards. Oversee the preparation and review of quality-related project documentation, including quality plans, inspection and test plans, and non-conformance reports. Analyze project data (records, schedules, and as-built construction data) to identify quality trends, evaluate root causes of deficiencies, and recommend corrective actions. Collaborate with project teams to establish quality objectives, metrics, and key performance indicators (KPIs) for all project phases. Independently apply quality assurance techniques and analytical methods to solve quality-related problems and improve processes. Ensure the quality and timeliness of deliverables across all projects, with a focus on continuous improvement. Provide training and mentorship to project teams. Participate in company activities and professional associations. Perform business development and marketing. Other duties as assigned. Who We Are Looking For: 10 to 15 years of progressive experience in quality assurance/quality control, preferably with experience on design-build transportation projects. Experience in transportation construction, transportation design, engineering consulting, or project management is considered beneficial. Qualifications Education/Knowledge: Professional Engineering Licensure in the Commonwealth of Virginia is required. A candidate who can obtain a license within three months may be considered. Knowledge of Virginia Department of Transportation's (DOT) specifications, standards, and construction expectations with an emphasis on design-build requirements, including but not limited to contract management, contract administration, and quality assurance/quality control, is strongly preferred. Similar state or federal DOT design-build experience will be considered. Knowledge of engineering principles of construction management and project controls. Knowledge of one or more of the following services: critical path method scheduling, cost estimating, project budgeting, delay analysis, constructibility and design review, inspections, quantity take-offs. Knowledge of arithmetic, algebra, geometry, statistics, and their applications. Knowledge of the structure and content of the English language, including the meaning and spelling of words, rules of composition, and grammar. Required Certifications: Professional Engineering Licensure in the Commonwealth of Virginia required (or ability to obtain within three months of hire). Possess OSHA 10-hour or OSHA 30-hour certification or obtain within 3 months of hire. Skills and Abilities: Computer proficiency in Microsoft Excel, Microsoft Word, Microsoft PowerPoint, and Bluebeam; additional capabilities in P6 preferred, and CADD desired. Serve as the project team leader and develop the project team to meet project objectives in a timely, positive, and collaborative manner. Work within a project team to complete project assignments. Execute tasks independently. Obtain and maintain industry certifications specific to duties assigned. Read and interpret engineering plans, specifications, and technical reports. Maintain records and prepare reports/correspondence related to the work. Use logic and reasoning to identify the strengths and weaknesses of alternative solutions, conclusions, or approaches to problems. Develop innovative, creative solutions to problems, while utilizing analytical skills. Deeply focus on the details of an assignment and then summarize findings for presentation to the project team leader. Listen and understand information and ideas presented through spoken words and sentences. Effectively communicate complex information and ideas verbally and in writing. Collaborate with project partners and clients, proactively managing conflicts, maintaining relationships, and maintaining accountability. Positively represent MBP within and outside of the workplace by acting with integrity in interpersonal interactions. Stand and sit as needed on project work sites, climb ladders, work at heights, and work outdoors in a wide range of weather conditions. Safely navigate construction work sites with uneven terrain. Guidance/Responsibility: Reports to the Group Manager in collaboration with the Transportation Service Line Leaders. Supervisory: Supervise team members in technical/administrative roles and provide training Lead project teams and oversee utilization What We Offer: We're focused on providing the tools and support you need to succeed, both personally and professionally. MBP offers a comprehensive benefits package including 100% employer-paid medical, dental, vision, life, and disability insurance (for individual employees), a 401(k) profit-sharing plan, a health savings account with company contributions, competitive compensation with opportunities for semi-annual bonuses, and generous paid time off. We also provide unique perks like tuition assistance, student loan repayment, annual gym reimbursement, pet insurance, and paid volunteer time. Additional benefits include mental health resources, company-wide wellness activities, and training and development to support your professional growth. MBP also covers the costs associated with obtaining and maintaining certifications and licenses, such as your Professional Engineering Licensure and OSHA certification. Status: Full-time Requirements: Applicants must be authorized to work in the U.S. without sponsorship. MBP is an equal opportunity employer. Protected veterans and individuals with disabilities are encouraged to apply.

Dentsply Sirona is the world's largest manufacturer of professional dental products and technologies, with a 130-year history of innovation and service to the dental industry and patients worldwide. Dentsply Sirona develops, manufactures, and markets a comprehensive solutions offering including dental and oral health products as well as other consumable medical devices under a strong portfolio of world class brands. Dentsply Sirona's products provide innovative, high-quality and effective solutions to advance patient care and deliver better and safer dentistry. Dentsply Sirona's global headquarters is located in Charlotte, North Carolina. The company's shares are listed in the United States on NASDAQ under the symbol XRAY. This position is located in Tulsa OK, in the heart of Green Country in Northeast Oklahoma, the city of Tulsa is the 2nd largest city in Oklahoma and prides itself on its growing economy, beautiful recreational and scenic destinations, and cultural attractions. Tulsa is a flourishing city with the friendliness and close-knit attitude of a much smaller town. Among the city's many advantages are choices of a variety of schools, businesses, museums, shopping centers, universities and cultural hotspots, making Tulsa a great place to live, work and raise a family! **Bringing out the best in people** As advanced as dentistry is today, we are dedicated to making it even better. Our people have a passion for innovation and are committed to applying it to improve dental care. We live and breathe high performance, working as one global team, bringing out the best in each other for the benefit of dental patients, and the professionals who serve them. If you want to grow and develop as a part of a team that is shaping an industry, then we're looking for the best to join us. Working at Dentsply Sirona you are able to: **Develop faster** - with our commitment to the best professional development. **Perform better** - as part of a high-performance, empowering culture. **Shape an industry** - with a market leader that continues to drive innovation. **Make a difference** -by helping improve oral health worldwide. **We are seeking a Quality Assurance Manager to lead our Quality team at the Johnson City site. This is a high-impact role where you will serve as the Site's Management Representative and the Person Responsible for Regulatory Compliance (PRRC) under EU MDR 2017/745.** **What You'll Do:** - Lead QA, QE, QC, and Post-Market Surveillance teams, overseeing all QMS activities defined in the quality manual. - Ensure compliance with FDA, ISO 13485, MDSAP, EU MDR and other applicable global medical device standards and regulations. - Provide oversight of sterile medical device manufacturing, including sterilization validation, monitoring, and routine controls. - Manage and support validations and controls in alignment with ISO 11137 (sterilization of healthcare products - radiation) and ISO 11737 (bioburden, sterility testing, endotoxins). - Represent the site in audits, inspections, and top management reviews. - Drive the CAPA process, risk management activities, and continuous improvement of quality systems. - Promote regulatory awareness and provide training across the organization. - Collaborate with R&D, Manufacturing, and RA to ensure quality and compliance across the product lifecycle. **What We're Looking For:** ✔️ 5+ years of proven experience in Quality Management within the medical device industry ✔️ Strong knowledge of **sterile medical device requirements** and sterilization validations (ISO 11137 / ISO 11737 series) ✔️ Solid background in ISO 13485, FDA QSR, MDSAP, and EU MDR requirements ✔️ Leadership skills to guide and grow cross-functional quality teams ✔️ Hands-on experience with CAPA, audits, and risk management Dentsply Sirona is an Equal Opportunity/ Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, age, sexual orientation, disability, or protected Veteran status. We appreciate your interest in Dentsply Sirona. If you need assistance with completing the online application due to a disability, please send an accommodation request to ************************** (********************) . Please be sure to include "Accommodation Request" in the subject. **For California Residents:** We may collect the following categories of personal information in connection with the submission of your resume or application materials to us for employment, and if hired, your employment with us: identifiers (e.g., name, address, email address, birthdate); personal records (e.g., telephone number, signature, education information, criminal background information, passport number and visa information); consumer characteristics (e.g., sex, marital status, veteran status, race, disability, sexual orientation); professional or employment information (e.g., resume, cover letter, employment history, background check forms, references, certifications, transcripts and languages spoken); and inferences from personal information collected (e.g., a profile reflecting abilities and aptitudes). The above categories of personal information are collected for the following business purposes: performing recruitment and hiring services; processing interactions and transactions (e.g., to comply with federal and state laws requiring us to maintain certain records, managing the workforce); and security (e.g., detecting security incidents, protecting against fraudulent or illegal activity). For additional details and questions, contact us at **************************

USAntibiotics, the only U.S. manufacturer of Amoxicillin products, is part of the Jackson Healthcare family of companies. We're always looking to add new talent to our teams, and we value diverse professionals who have strong leadership skills, align with our culture, and are committed to excellence. The Manger, QC Laboratories leads Chemistry laboratory operations supporting solid oral dosage forms (tablets, capsules and powders). This role endures timely, accurate, and compliant testing of raw materials, in-process samples, finished products, and stability studies. The manager drives data integrity, operational efficiency, and regulatory compliance while fostering a culture of scientific rigor and continuous improvement. Provide specialized technical support within the Quality Control Laboratory as assigned. Provide leadership/training to less experienced staff, as assigned to assure efficient and valid analytical laboratory support. Assist with supervisory duties in the absence of Management (including review and approval of analytical data per cGMPs and regulatory requirements). Perform analytical testing of all sample types as assigned.ESSENTIAL RESPONSIBILITIES: Laboratory Operations Direct daily scheduling and prioritization of testing for raw materials, in-process, finished products, and stability samples to meet production timelines. Ensure timely review and approval of analytical data, certificates of analysis, and batch records to support product release and regulatory commitments. Maintain inspection readiness through robust documentation practices and adherence to SOPs. Perform technical duties in specialized area. Assist laboratory supervisors with tasks, as needed. Technical Leadership Oversee method transfers, verifications, and validations for solid oral dosage forms per ICH Q2 guidelines. Troubleshoot analytical issues such as chromatographic resolution failures, dissolution anomalies, and system suitability deviations. Approve validation protocols, reports, and stability study designs; ensure compliance with compendial standards (USP/EP). Recommend changes to methods and Lab operations as appropriate to help gain efficiency. Perform satisfactorily on all analysts' qualifications studies, indicating technical proficiency. Plan, perform, and document non-routine tests (or special studies) and investigations. Compliance & Data Integrity Enforce cGMP, 21 CFR Parts 210/211, and Part 11 requirements across all lab operations. Implement ALCOA+ principles for data integrity in electronic systems (LIMS, CDS) and paper records. Lead investigations for OOS/OOT results, root cause analysis, and implement effective CAPAs; trend data for continuous improvement. Document all results in accordance with cGMPs and written procedures. Interpret analytical results correctly, notifying Senior Management promptly of both situations that indicate analytical issues and manufacturing or product issues. Serve as technical resource during Regulatory inspections and internal audits as required. Also, conduct internal audits and self-inspections as required. Provide information to outside vendors and technical representatives in a professional manner. People Management Recruit, train, and develop QC Analysts and Senior Analysts/Chemists; maintain training matrices and competency assessments. Foster a culture of accountability, engagement, and scientific excellence through coaching and performance management. Ensure cross-training to maintain operational flexibility and coverage. Equipment & Safety Manage lifecycle of analytical instruments (HPLC/UPLC, GC, UV/Vis, FTIR, Dissolution, KF, TOC), including qualification, calibration, and preventive maintenance. Oversee spare parts inventory and service contracts to minimize downtime. Promote chemical hygiene, hazardous waste handling, and compliance with safety regulations; drive zero-injury performance. Continuous Improvement Monitor and report QC KPIs (turnaround time, right-first time, OOS/OOT rates, instrument uptime). Implement Lean/Six Sigma initiatives to reduce cycle times, improve efficiency, and optimize workflows. Drive digital transformation projects (e.g., LIMS enhancements) for improved compliance and productivity. Maintain and improve proficiency of operations through training. Write validation reports, analytical procedure SOPs and equipment SOPs as required. Notify Senior Management of any SOPs that may require revision and initiate change requests per written policy, providing sufficient evidence/documentation to support change request. Other Conduct special studies in accordance with protocols and direction of management. Prepare well documented reports of results. Carry out other duties as assigned by Senior Management QUALIFICATIONS - EDUCATION, WORK EXPERIENCE, CERTIFICATIONS: Required Qualifications Bachelor's degree in Chemistry or related field. 5+ years in GMP QC Chemistry labs for solid oral dosage forms, with 3-5 + years in leadership Expertise in chromatographic techniques (HPLC/UPLC/GC), dissolution testing, and compendial methods (USP/EP). Strong knowledge of cGMP, ICH Q2/Q9/Q10, and data integrity principles. Experience with LIMS and Chromatography data systems (e.g., Empower). Preferred Qualifications Master's preferred Method development experience, Lean/Six Sigma certification, proven success in regulatory inspections. Previous pharmaceutical industry experience KNOWLEDGE, SKILLS, AND ABILITIES: Scientific judgement and problem-solving Compliance and ethical integrity Leadership and team development Operational excellence and continuous improvement Clear communication and stakeholder influence Demonstrated ability to perform a wide variety of chemical, instrumental, and chromatographic analyses Ability to prioritize and decide appropriate course of action. Consistently notifies Management of possible compliance and technical issues and suggests/implements corrective actions. Ability to handle multiple priorities efficiently and make/implement decisions Fully versed in cGMPs, FDA, and other regulatory agency requirements. Ability to function independently on special projects and follow through to successful completion Ability to work in a team multi-disciplinary environment interacting on a professional level with peers subordinate and senior personnel. Ability to maintain confidentiality. TRAVEL REQUIREMENTS & WORKING CONDITIONS: This role is primarily in-office which is expected to be onsite at least 5 days/week. Up to 5% travel may be required The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions While performing the duties of this job, the employee is frequently required to stand; walk; sit; use hands to finger, handle, or feel; write; type; reach with hands and arms; climb or balance; stoop, kneel, crouch, or crawl; talk or hear Specific vision abilities required by this job include close vision, distance vision, and ability to adjust focus EEO Statement: We are an Equal Opportunity Employer and do not discriminate based on race, color, religion, sex, national origin, age, disability, veteran status, or any other protected status under the law.

GARNEY CONSTRUCTION A Quality Control Manager position in Kingsport, TNis available at Garney Construction. Join our Garney team to manage and support project Quality Management Specialists, ensuring each project is successful. The Quality Control Manager is responsible for the implementation, management, and execution of Quality Management Programs for Federal contracting projects. WHAT YOU WILL BE DOING Develop and implement project Quality Management Systems to ensure compliance with contract quality standards Review project CPM schedule to anticipate and request timely submittals Review project schedules and prepare Government meeting notices to support schedules Conduct weekly Quality Control meetings Perform/supervise quality inspections as needed by the project or Project Manager Provide effective and efficient communication with the Federal Government personnel Promote Garney's safety programs and procedures to promote a safe working environment WHAT WE ARE LOOKING FOR 10 years of construction experience, 3 years being Construction Quality Manager experience Bachelor's Degree in Engineering, Construction Management, or related field Current USACOE Construction Quality Management for Contractors Certification EM 385 40 hour and OSHA 30-hour certifications Current Professional Engineering Registration in the State of TN Minimum 5yr Construction Experience as a Project Superintendent, Quality Control Manager, Project Manager, Project Engineer, or Construction Manager in Heavy Civil Construction Minimum 2yr experience as Quality Control Manager. Familiar with EM-385-1-1 Fluent in English Language LET'S TALK THE PERKS! Employee Stock Ownership Plan (ESOP) 401K Retirement plan Health, dental, vision and life insurance Flexible Spending Account (FSA) / Health Savings Account (HSA) Long-term disability Wellness program Employee Assistance Plan Holidays and PTO Bonus program CONTACT US If you are interested in this Quality Control Manager position in Kingsport, TN then please APPLY NOW. For other opportunities available at Garney Construction go to careers.garney.com. If you have questions about the position or would like more information, please contact Patrick Duque - Recruiter by email at ************************. Garney Construction and its subsidiaries are committed to hiring and retaining a diverse workforce. We are proud to be an Equal Opportunity/Affirmative Action Employer and it is our policy to provide equal opportunity to all people without regard to race, color, religion, national origin, ancestry, marital status, veteran status, age, disability, pregnancy, genetic information, citizenship status, sex, sexual orientation, gender identity or any other legally protected category. Garney Construction is a background screening, drug-free workplace. Agency Disclaimer: All vendors must have a signed Garney Construction Agreement, authorized by the Executive Team, to receive payment for any placement. Verbal or written commitments made by anyone other than a member of the Executive Team will not be considered binding. Any unsolicited resumes sent to Garney Construction or submitted to employees outside of the Recruiting Team will be deemed the property of Garney Construction. In such cases, Garney Construction will not be obligated to pay any placement fees.

Turner Industries is a fully diversified industrial contractor. We help move the world forward by providing responsive, innovative solutions designed to increase plant production, reduce costs, reduce downtime, and even prevent shutdowns. Headquartered in Baton Rouge, LA, Turner Industries has over 20,000 employees with offices and job sites across the United States. Our single-solution approach in the petrochemical, refining, energy, pulp and paper, and related industries has made Turner one of the nation's top industrial contractors and earned us the No. 1 spot on ABC's 2024 Top Performers list. People are at the heart of everything we do. Their safety, security, and satisfaction have always been our top priorities. For proof, look no further than our strong working relationships and extraordinary workforce. We are seeking a Lead QA/QC for a position in Kingsport, TN. This role is responsible for planning and coordinating the quality control program designed to ensure continuous production of products consistent with established standards. Non-exempt role; Reports to Site QC Manager or QC Supervisor; Performs a variety of routine duties within established policies. Essential Qualifications: Minimum of 7 - 10 years experience Certified Welding Inspector (CWI) preferred Excellent communication, interpersonal, organizational, and problem solving skills Computer Literacy Ability to read isometric diagrams, PIDs, CAD drawings, etc. Interpreting / Understanding 3D modeling Post offer drug / alcohol screen, physical evaluation, and signed acceptance of the Turner Industries Drug, Alcohol and Contraband Policy Comply with company and client job site safety requirements Must not pose a direct threat to the health or safety of others in the workplace Functional Requirements: Develops an understanding and working knowledge of the company quality control program, company standards, procedures, codes, etc. required to perform assigned work; performs inspections and witnesses tests to determine acceptability of work; performs audits to ensure compliance with QA/QC requirements; defines corrective measures for problem areas and ensures implementation; formulates and maintains quality control objectives and supervises workers engaged in plant functions, such as inspection and testing to ensure continuous quality control over materials and production facilities; develops and analyzes statistical data and specifications to indicate present product standards and establish proposed quality and reliability expectancy of finished product; plans, promotes, and organizes quality and reliability activities; maintains work performance records, inspection records and other related items; assures correctness of all documents; perform additional assignments per supervisor's direction Compensation Final agreed upon compensation is based upon individual qualifications and experience. Benefits Depending on your employment status, benefits include health, dental, vision, life, ADD, voluntary life / ADD, disability benefits, leaves of absence, 401k, paid time off, paid holidays, telehealth access, and employee assistance program. Physical Involvement: Employee may be required to do the following: climbing ladders, scaffolds, structures, etc. above and below ground level; maintaining balance on ladders, scaffolds, structures, etc.; reaching in all directions, handling and manipulating objects and materials; coordinating the movement of eyes, hands and fingers to operate tools and equipment; lifting 30-50 lbs. from ground level, waist level, and/or overhead; carrying objects, tools, etc.; standing; sitting; walking; seeing with or without correction; hearing with or without correction; following set procedures and standards; applying basic mathematical skills; planning work; comparing and understanding differences in the size, shape and form of lines, figures and objects; picturing and evaluating solid objects from drawings or diagrams using standards that can be measured or checked; following oral and/or written directions, plans and blueprints; reading; writing; ability to recognize and report safety hazards Turner Industries is an equal employment opportunity employer. All qualified individuals will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, national origin, disability and/or protected veteran status in accordance with governing law. Keywords: quality control, inspection, certified welding inspector, CWI, quality control technician, quality control manager, isometric diagrams, PIDs, CAD drawings, welding, welding inspection, quality control program, quality codes, QA/QC, quality assurance, quality control objectives, production facility, quality activities, reliability activities, inspection records

Huf NA, Greeneville (TN) I United States (US) Junior Quality Engineer We are a leading developer and manufacturer of mechanical and electronic locking systems as well as car access and authorization systems for the global automotive industry. Founded in 1908 in Velbert, Germany, we are an independent, family-owned company with around 7,500 employees at locations in Europe, America and Asia and achieved sales of more than EUR 1.2 billion in the financial year 2023. Your Role * Perform inspections, basic data analysis, documentation, and response to nonconforming conditions * Read control plans, blue prints, and product specifications to determine product quality requirements * Full understanding of all quality requirements of the product and is responsible to maintain quality * Full understanding of work instructions related to appearance guidelines for painted parts to make decisions based on the guidelines * Communicate customer and internal concerns and follow up with quality alerts with the team * Responsible for safe launch activities including performing inspections, tests, and data analysis to detect defects and ensure products meet defined requirements * Perform visual inspection of painted product to identify cosmetic defects and color matching * Responsible for training metric for all associates along with maintaining the training records * Monitor all assembly and paint line and provide coaching to the associates on viewing and training * Analyze quality data and contribute to the continuous improvement of overall product quality Your Skills * High School Diploma/ General Education Degree (GED), Two year degree preferred * Excellent math and reading skills * Good Computer literacy (Microsoft Word, Excel, required; PowerPoint preferred) * Excellent attendance and work habits * Ability to work independently and make consistent decisions * Prior paint viewing experience preferred * Bilingual (Spanish) preferred but not mandatory * Experience with methods of 8D and 5 Whys What we offer * Full comprehensive health insurance, dental, vision, flexible spending account * Disability insurance * 401(k) with company match * Paid Time Off Huf celebrates diversity, supports inclusiveness and encourages individual expression in our workplace. We do not tolerate the harassment or discrimination toward any of our applicants or employees. We are an equal opportunity employer. Huf North America Automotive Parts Manufacturing, Corp. Michelle Myers

Company / Location Information A.O. Smith is a global leader applying innovative technologies and energy-efficient solutions to products manufactured and marketed worldwide. The company is one of the world's leading manufacturers of residential and commercial water heating equipment and boilers, as well as a manufacturer of water treatment products for residential and light commercial applications. A. O. Smith is headquartered in Milwaukee, Wisconsin, with approximately 12,000 employees at operations in the United States, Canada, China, India, Mexico, the Netherlands, and the United Kingdom. Primary Function The Quality Engineering Early Career program offers individuals the opportunity to gain comprehensive experience and knowledge within A. O. Smith's quality engineering disciplines that support the business. The program spans approximately 15 - 18 months, providing hands-on experience through rotations in key quality functional areas. Each rotation lasts around 5 - 6 months, though the duration may vary based on the role and skills being developed. Participants will engage in a mentoring program with functional leaders and present their progress to the leadership team at the end of each rotation. Upon successful completion, participants will transition into a quality engineering role that aligns with their skills, career goals, and business needs. Growth & Development: The program is designed to equip candidates with the tools necessary to fast-track their career growth and become a valued member of A.O. Smith. Through extensive exposure to various quality engineering disciplines, participants will gain unique skills, understand the business, and build a broad network across the company to maximize their potential. Participants will also benefit from additional career development and support through the following opportunities: Mentor Program: The candidate will be partnered with a dedicated mentor that will provide coaching and guidance throughout the program. Professional Development: The candidate will benefit from various professional development opportunities, including: * Presenting to business leadership at the end of rotations, highlighting completed projects, acquired skills, and key lessons learned * Participating in formal classroom training on topics such as project management, presentation skills, quality management systems, quality engineering techniques, and more * Gaining product / process knowledge and an understanding of product applications Responsibilities * Performs routine quality engineering tasks using standard techniques under supervision. * Provides entry level support to the senior engineer / supervisor. * Performs a supervised role in ensuring that the company's and customers' requirements are met on assigned products, programs, areas, or functions. * Develop competence in quality engineering methods by performing structured work assignments. * Monitor and assist in the implementation of internal quality controls and testing to meet quality procedures and norms. * Participate in Quality System assessments / audits (1st / 2nd / 3rd party) as assigned. * Prepare quality analysis and provide input to recommend necessary changes to quality procedures. * Participate in root cause analysis to determine the cause of quality problems and implement corrective and preventative actions under supervision. * Perform any other activities as needed or as directed. * Exemplify professional conduct in accordance with AOS Values Qualifications Minimum Qualifications: * B.S. in Engineering or Engineering Technology (seeking upcoming / recent graduates): Mechanical Engineering, Industrial Engineering, Engineering Technology, and Mechatronics Engineering preferred. * 0-2 years of applicable experience in or exposure to manufacturing, quality, and technical environments (would consider intern/co-op experience) * Cumulative GPA of 3.0 or higher * Strong communication and leadership abilities * Must be open to relocation within the United States * Travel may be required (up to ~40%) as necessary. * Ability to work independently and as a team to meet deadlines and goals Preferred Qualifications: * Prior internship / co-op experience in a manufacturing setting strongly preferred * Exposure to blueprint interpretation and metrology methods are a plus * Knowledge of statistical analysis methods a plus * Exposure to Minitab (equivalent statistical analysis software) and Microsoft Office a plus We Offer Competitive compensation package and comprehensive benefits plans which include medical and dental insurance, company-sponsored life insurance, retirement security savings plan, short- and long-term disability programs and tuition assistance. #LI-Onsite #LI-AO ADA Statement & EEO Statement In developing this job description care was taken to include all competencies needed to successfully perform in this position. However, for Americans with Disabilities Act (ADA) purposes, the essential functions of the job may or may not have been described for purposes of ADA reasonable accommodation. All reasonable accommodation requests will be reviewed and evaluated on a case-by-case basis. We consider all applicants for employment without regard to race, color, religion, gender, sexual orientation, national origin, age, disability, gender identity and expression, marital or military status. We also provide reasonable accommodations to qualified individuals with disabilities in accordance with the Americans with Disabilities Act and applicable state and local law. Nearest Major Market: Asheville Nearest Secondary Market: Knoxville Job Segment: Statistics, Quality Engineer, Wastewater, Water Treatment, Manufacturing Engineer, Data, Engineering

This role is designed to support the APQP incorporation within GE West Jefferson. The role includes Advance Product Quality Planning, First Article Inspection, Preparation of Master Specs per S-043, Problem solving, and general shop quality tasks. Job Description Roles and Responsibilities * Ownership of Quality for an entire business unit and all associated hardware; Blisk, HPT, Spools, or Venture. The quality team will convene to determine the best location depending on candidate experience * Ownership includes both quality assurance and quality control. Includes quality assurance of products, services, manufacturing processes. Includes conformance in manufacturing, incoming goods control, product inspection, witness points, etc. * Participation in Lean transformation events to support the culture transformation currently under way within the shop * Understanding of key business drivers; uses this understanding to accomplish own work. Good understanding of how work of own team integrates with other teams and contributes to the area. * May have some autonomy to make decisions within a defined framework. Resolves issues in situations that require good technical knowledge and judgment within established procedures. Consults more senior team members for issues outside of defined instructions/parameters. * A job at this level requires good interpersonal skills and will be required to provide technical leadership to a cross-functional team * APQP incorporation Required Qualifications * Bachelor's Degree accredited college or university (or a high school diploma / GED with a minimum of 4 years of experience in quality Engineering and Manufacturing experience) + Minimum of 3 years of quality Engineering and Manufacturing experience Desired Characteristics * Demonstrated competence in MS Office * Previous Quality experience minimum 5 years * Familiar with Six Sigma practices * Experience with APQP * Experience with FAI and Quality Inspection Plans * Experience with AS9100 * Familiarity with inspection equipment * Experience with Lean practices * Experience with Root Cause Analysis * Strong oral and written communication skills. Ability to document, plan, market, and execute programs. * Humble: respectful, receptive, agile, eager to learn * Transparent: shares critical information, speaks with candor, contributes constructively * Focused: quick learner, strategically prioritizes work, committed * Leadership ability: strong communicator, decision-maker, collaborative * Problem solver: analytical-minded, challenges existing processes, critical thinker GE Aerospace offers comprehensive benefits and programs to support your health and, along with programs like HealthAhead, your physical, emotional, financial and social wellbeing. Healthcare benefits include medical, dental, vision, and prescription drug coverage; access to a Health Coach from GE Aerospace; and the Employee Assistance Program, which provides 24/7 confidential assessment, counseling and referral services. Retirement benefits include the GE Aerospace Retirement Savings Plan, a 401(k) savings plan with company matching contributions and company retirement contributions, as well as access to Fidelity resources and planning consultants. Other benefits include tuition assistance, adoption assistance, paid parental leave, disability insurance, life insurance, and paid time-off for vacation or illness. GE Aerospace (General Electric Company or the Company) and its affiliates each sponsor certain employee benefit plans or programs (i.e., is a "Sponsor"). Each Sponsor reserves the right to terminate, amend, suspend, replace or modify its benefit plans and programs at any time and for any reason, in its sole discretion. No individual has a vested right to any benefit under a Sponsor's welfare benefit plan or program. This document does not create a contract of employment with any individual. This role requires access to U.S. export-controlled information. Therefore, employment will be contingent upon the ability to prove that you meet the status of a U.S. Person as one of the following: U.S. lawful permanent resident, U.S. Citizen, have been granted asylee or refugee status (i.e., a protected individual under the Immigration and Naturalization Act, 8 U.S.C. 1324b(a)(3)). Additional Information GE Aerospace offers a great work environment, professional development, challenging careers, and competitive compensation. GE Aerospace is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status or other characteristics protected by law. GE Aerospace will only employ those who are legally authorized to work in the United States for this opening. Any offer of employment is conditioned upon the successful completion of a drug screen (as applicable). Relocation Assistance Provided: Yes

Full-time Asheville, NC (On-site) $95,000 - $120,000 salary + benefits About Us The Ammortal Chamber brings together multiple scientifically backed technologies into one experience. It is a healing technology that can be utilized by wellness clinics and inside the home. Our clients include specialty spas and clinics, sports teams, and individuals who are biohackers or athletes. We are a small team with a startup culture. After our first full year shipping a finished product on the market, we've shown strong growth. Our team is made up of engineers, health professionals, and startup entrepreneurs. As we continue expanding, this role offers hands-on experience, opportunities to grow into leadership, and the chance to make a tangible impact by developing and delivering cutting-edge wellness technology. You'll collaborate across disciplines to innovate and shape technologies that enhance well-being for our clients. What is this role and why does it exist? The Sustaining Quality Engineer exists to ensure the long-term reliability, quality, and performance of the Ammortal Chamber once it's in the field. As we scale and deploy more systems worldwide, maintaining consistency and solving the root cause of field issues is essential to our mission of helping people unlock their potential. This role owns the root cause and corrective action process (RCCA), drives and simplifies our Engineering Change Request (ECR) and Engineering Change Order (ECO) system, and provides on-call technical support for our field service technicians. The Sustaining Quality Engineer acts as a key bridge between Manufacturing, Engineering, and Operations-ensuring lessons from the field translate into continuous improvement in design and production. Responsibilities On-Call Technical Support - Provide troubleshooting and guidance for internal teams and customer units in the field when issues arise. Root Cause Analysis & Corrective Actions - Lead investigations of product issues in the field, drive containment, and implement robust corrective actions that prevent recurrence. ECR/ECO Process Support - Validate and trial engineering changes before release, provide manufacturability and reliability feedback, initiate ECRs based on issues or observations, and ensure all approved changes are properly documented and reflected in controlled systems. Final Product QC - Perform final quality inspections to verify each Chamber meets all specifications, functionality requirements, and shipment-ready standards before release. Cross-Functional Collaboration - Work directly with Manufacturing, Engineering, and Operations to ensure smooth communication and alignment between field data and internal improvements. Sustaining Engineering - Maintain released designs, support product updates, and support lifecycle quality improvements. Skills to Excel Technical Communication: Can clearly document findings, ECR/ECOs, and communicate resolutions to both technical and non-technical audiences. Calm Under Pressure: Able to triage and respond quickly and calmly during urgent field issues, balancing precision and speed. Analytical Problem Solving: Expert at diagnosing technical failures and implementing data-driven root cause and corrective actions. Cross-Functional Collaboration: Works fluidly with Engineering, Manufacturing, and Operations to close the loop on field feedback. Process Ownership: Drives change control and documentation rigor with attention to detail and consistency. Requirements Qualifications (Must Haves) 3+ years in a sustaining, quality, or reliability engineering role within an electro-mechanical or hardware manufacturing environment. Proven experience leading root cause investigations and implementing corrective actions (8D, DMAIC, Fishbone, etc.). Experience with ECR/ECO systems and documentation management. Strong communication and organizational skills. Based in or willing to relocate to Asheville, NC and work onsite full time. Qualifications (Nice to Haves) Experience working with Contract Manufacturers and field service teams. Exposure to ISO 9001 or other Quality Management Systems. Familiarity with ERP/MRP systems for traceability and change control. Understanding of electronics or mechatronic systems. What Technical Knowledge Do You Need to Perform in This Role? Required Root Cause and Corrective Action methodologies (8D, 5 Whys, Fishbone). Understanding of mechanical and electrical troubleshooting principles. Experience managing ECR/ECO workflows and documentation tools. Preferred Familiarity with SolidWorks, Altium, or similar CAD systems for design review. Experience with quality and reliability tracking tools (SPC, FMEA). Exposure to regulatory or safety compliance standards (UL, CE). Benefits Pay, Location, Hours Pay Range: $95,000 - $120,000 Benefits: 80% healthcare, dental, and vision covered Location: Onsite at Ammortal HQ - Mars Hill, NC (right outside of Asheville) Relocation Assistance: If you are not local or within commuting distance, we offer a $3,000 relocation stipend

Job Description Full-time Asheville, NC (On-site) $95,000 - $120,000 salary + benefits About Us The Ammortal Chamber brings together multiple scientifically backed technologies into one experience. It is a healing technology that can be utilized by wellness clinics and inside the home. Our clients include specialty spas and clinics, sports teams, and individuals who are biohackers or athletes. We are a small team with a startup culture. After our first full year shipping a finished product on the market, we've shown strong growth. Our team is made up of engineers, health professionals, and startup entrepreneurs. As we continue expanding, this role offers hands-on experience, opportunities to grow into leadership, and the chance to make a tangible impact by developing and delivering cutting-edge wellness technology. You'll collaborate across disciplines to innovate and shape technologies that enhance well-being for our clients. What is this role and why does it exist? The Sustaining Quality Engineer exists to ensure the long-term reliability, quality, and performance of the Ammortal Chamber once it's in the field. As we scale and deploy more systems worldwide, maintaining consistency and solving the root cause of field issues is essential to our mission of helping people unlock their potential. This role owns the root cause and corrective action process (RCCA), drives and simplifies our Engineering Change Request (ECR) and Engineering Change Order (ECO) system, and provides on-call technical support for our field service technicians. The Sustaining Quality Engineer acts as a key bridge between Manufacturing, Engineering, and Operations-ensuring lessons from the field translate into continuous improvement in design and production. Responsibilities On-Call Technical Support - Provide troubleshooting and guidance for internal teams and customer units in the field when issues arise. Root Cause Analysis & Corrective Actions - Lead investigations of product issues in the field, drive containment, and implement robust corrective actions that prevent recurrence. ECR/ECO Process Support - Validate and trial engineering changes before release, provide manufacturability and reliability feedback, initiate ECRs based on issues or observations, and ensure all approved changes are properly documented and reflected in controlled systems. Final Product QC - Perform final quality inspections to verify each Chamber meets all specifications, functionality requirements, and shipment-ready standards before release. Cross-Functional Collaboration - Work directly with Manufacturing, Engineering, and Operations to ensure smooth communication and alignment between field data and internal improvements. Sustaining Engineering - Maintain released designs, support product updates, and support lifecycle quality improvements. Skills to Excel Technical Communication: Can clearly document findings, ECR/ECOs, and communicate resolutions to both technical and non-technical audiences. Calm Under Pressure: Able to triage and respond quickly and calmly during urgent field issues, balancing precision and speed. Analytical Problem Solving: Expert at diagnosing technical failures and implementing data-driven root cause and corrective actions. Cross-Functional Collaboration: Works fluidly with Engineering, Manufacturing, and Operations to close the loop on field feedback. Process Ownership: Drives change control and documentation rigor with attention to detail and consistency. Requirements Qualifications (Must Haves) 3+ years in a sustaining, quality, or reliability engineering role within an electro-mechanical or hardware manufacturing environment. Proven experience leading root cause investigations and implementing corrective actions (8D, DMAIC, Fishbone, etc.). Experience with ECR/ECO systems and documentation management. Strong communication and organizational skills. Based in or willing to relocate to Asheville, NC and work onsite full time. Qualifications (Nice to Haves) Experience working with Contract Manufacturers and field service teams. Exposure to ISO 9001 or other Quality Management Systems. Familiarity with ERP/MRP systems for traceability and change control. Understanding of electronics or mechatronic systems. What Technical Knowledge Do You Need to Perform in This Role? Required Root Cause and Corrective Action methodologies (8D, 5 Whys, Fishbone). Understanding of mechanical and electrical troubleshooting principles. Experience managing ECR/ECO workflows and documentation tools. Preferred Familiarity with SolidWorks, Altium, or similar CAD systems for design review. Experience with quality and reliability tracking tools (SPC, FMEA). Exposure to regulatory or safety compliance standards (UL, CE). Benefits Pay, Location, Hours Pay Range: $95,000 - $120,000 Benefits: 80% healthcare, dental, and vision covered Location: Onsite at Ammortal HQ - Mars Hill, NC (right outside of Asheville) Relocation Assistance: If you are not local or within commuting distance, we offer a $3,000 relocation stipend

The Quality Assurance Manager, Contract Manufacturers (CMOs) oversees all quality-related activities for external manufacturing partners producing OTC semisolid drug products. This includes compliance with FDA 21 CFR Part 210/211, CHPA guidelines, ICH Q7/Q9/Q10, supplier quality expectations, and internal QMS requirements. Reporting to: Director, Quality Services Location: Johnson City, TN - onsite Responsibilities/Essential Duties: Provide quality oversight of CMOs producing OTC semisolid products. Develop and maintain Quality Agreements. Plan and execute GMP audits; support regulatory inspections. Review batch documentation, deviations, and OOS/OOT investigations. Provide technical QA oversight for semisolid manufacturing processes. Oversee complaint investigations, CAPA management, and effectiveness checks. Evaluate and approve change controls from CMOs. Oversee stability program execution and data review. Manage supplier and material quality, including qualification, requalification, and specification control. Ensure supplier notifications, investigations, and raw material issues are managed per GMP. Support continuous improvement and QMS enhancements. Office-based with travel to CMOs and supplier sites. Ability to wear PPE as required. Basic Qualifications: Bachelor's degree & 5+ years' directly related experience. Preferred Qualifications: Bachelor's degree in scientific or engineering field. 5-10 years' QA experience in pharmaceuticals, OTC, or semisolid manufacturing. Experience managing CMOs and suppliers. Knowledge of FDA 21 CFR 210/211 and ICH Q guidelines. Technical expertise in semisolid manufacturing quality standards. Strong auditing and communication skills. Proficiency with electronic QMS platforms. Company Summary: Crown is a proud member of the Revance Portfolio of skincare offerings. Revance is a fast-growing global aesthetics and skincare company focused on providing innovative aesthetics and market-leading skincare offerings throughout every stage of life. With a differentiated portfolio of products spanning 60 countries, Revance meets the evolving needs of patients and consumers worldwide through continued innovation and commercialization of new products and treatments. What Revance invests in you: Competitive Compensation including base salary and annual performance bonus. Flexible PTO, holidays, and parental leave. Generous healthcare benefits, HSA match, 401k match, employer paid life and disability insurance, pet insurance, wellness discounts and much more! This section of the is required by the American with Disability Act (ADA). The ADA requires that job descriptions reflect the physical and mental demands required to effectively perform the essential duties of the job. The ADA prohibits employers from discriminating against a “qualified individual with a disability” in all aspects of the employment relationship. A “qualified individual with a disability” is “an individual who meets the education, experience, skill, and other job-related requirements of a position held or desired, and who, with reasonable accommodation, can perform the essential functions of a specified job.” Revance is an Equal Opportunity employer. All qualified applicants will receive consideration for employment based on merit, without regard to race, color, religion, sex, national origin, disability, protected Veteran Status, or any other characteristic protected by applicable federal, state, or local law.

Comprehensive relocation assistance is provided to the qualified candidate! Our award-winning client is seeking a Quality Engineering Lead to join their team. Our award-winning global leader in high-performance battery separators seeks a passionate Quality Lead to join their team. Responsibilities: Spearhead IATF 16949 certification for our lithium-ion battery separator expansion project, ensuring the highest quality standards. Maintain company accreditations (ISO 9001, IATF 16949), guaranteeing compliance and exceeding industry benchmarks. Lead internal and customer quality audits to identify and address any potential issues. Champion continuous improvement by managing internal QMS audits and layered process audits. Develop and refine quality management system processes for optimal efficiency. Report key performance indicators (KPIs) to senior management, providing actionable insights. Foster a culture of quality awareness by effectively communicating customer requirements throughout the organization. Required Qualifications: A bachelor's degree in a relevant field is required. (e.g., Engineering, Quality Management). 5+ years of experience with IATF 16949 Quality Management Systems. Project management experience in the battery industry is a plus. IATF certification auditor certification preferred. Strong communication, collaboration, and customer service skills. Experience working across departments (Sales, R&D, Operations). Excellent written, verbal, and listening skills. Ability to work independently and manage multiple priorities.

Apply now " Company: Dentsply Sirona, Inc Dentsply Sirona is the world's largest manufacturer of professional dental products and technologies, with a 130-year history of innovation and service to the dental industry and patients worldwide. Dentsply Sirona develops, manufactures, and markets a comprehensive solutions offering including dental and oral health products as well as other consumable medical devices under a strong portfolio of world class brands. Dentsply Sirona's products provide innovative, high-quality and effective solutions to advance patient care and deliver better and safer dentistry. Dentsply Sirona's global headquarters is located in Charlotte, North Carolina. The company's shares are listed in the United States on NASDAQ under the symbol XRAY. This position is located in Johnson City which is the largest city in the Tri-Cities area, located in the north eastern region of Tennessee at the foothills of the Appalachian Mountains. The city is a growing metropolis with invigorating music, enchanting culture, and exhilarating mountain adventures. Its natural beauty and fresh mountain air combined with amenities that are often only available in larger cities make Johnson City the perfect location. Bringing out the best in people As advanced as dentistry is today, we are dedicated to making it even better. Our people have a passion for innovation and are committed to applying it to improve dental care. We live and breathe high performance, working as one global team, bringing out the best in each other for the benefit of dental patients, and the professionals who serve them. If you want to grow and develop as a part of a team that is shaping an industry, then we're looking for the best to join us. Working at Dentsply Sirona you are able to: Develop faster - with our commitment to the best professional development. Perform better - as part of a high-performance, empowering culture. Shape an industry - with a market leader that continues to drive innovation. Make a difference -by helping improve oral health worldwide. Our Johnson City, TN Location is looking for someone to join our team as a Quality Engineer / Microbiological Specialist. We offer competitive wages and a full menu of benefits including health (3 options), dental (provided), vision, life (provided) + extra life, short-term and long-term disability (provided), 401k (retirement) with company matching, 10 holidays and paid time off. SCOPE The Quality Engineer / Microbiological Specialist is responsible for establishing, maintaining, and continuously improving all validation, sterilization, and microbiological control activities at the Johnson City site. This role serves as the site Subject Matter Expert (SME) for gamma sterilization, microbiological testing, environmental monitoring, and equipment and process validation across all manufacturing and support processes. The position ensures compliance with applicable standards and regulations (ISO 13485, ISO 11137, ISO 11737, and FDA 21 CFR 820), supports audit readiness, and drives risk-based improvements to maintain validated and controlled processes that ensure product quality and patient safety. KEY RESPONSIBILITIES * Sterilization Validation & Oversight * Lead and maintain sterilization validation programs for products sterilized by gamma radiation, ensuring full compliance with ISO 11137-1/-2/-3 and FDA 21 CFR 820.75. * Develop and execute sterilization validation protocols (IQ/OQ/PQ) and periodic requalification per the Dentsply Sirona global validation procedure. * Manage dose audit and bioburden monitoring programs, analyzing trends and escalating deviations through the QMS. * Support supplier qualification and change control related to contract sterilization facilities. * Collaborate with R&D and Manufacturing Engineering to ensure new or transferred products are compatible with established sterilization parameters. B. Microbiological Controls & Test Method Validation * Lead and maintain test method validations and verifications for microbiological assays (bioburden, sterility, bacterial endotoxins) in compliance with ISO 11737 parts 1, 2 and 3 and USP-NF 2024. * Oversee periodic method suitability testing and recovery studies with external laboratories. * Review and approve microbiological test reports, ensuring data integrity and traceability in SmartSolve. * Evaluate and approve laboratory control changes, ensuring continued suitability for intended use. C. Environmental & Cleanroom Monitoring * Own and maintain the environmental monitoring (EM) program for controlled areas and cleanrooms used for product assembly and packaging, ensuring compliance with ISO 14644 and ISO 14698. * Review EM trending data, initiate and lead investigations for out-of-limit (OOL) or alert-level events, and ensure CAPAs are properly documented in SmartSolve. * Support cleanroom qualification/requalification and pressure cascade verification activities in partnership with Facilities and Engineering. * Provide technical guidance to operations on aseptic practices, gowning, and material flow to prevent contamination. D. Compliance & Continuous Improvement * Ensure alignment with the Global Quality System (GQS) and local SOPs for sterilization, environmental control, and microbiological testing. * Author, review, and maintain SOPs, work instructions, and validation reports related to sterilization and microbiological processes. * Represent the site during internal and external audits (FDA, BSI, TÜV, MDSAP) as the sterilization and microbiology SME. * Identify opportunities for process improvements, risk reduction, and enhanced contamination control. E. Cross-Functional and Global Collaboration * Work closely with R&D, Manufacturing Engineering, Regulatory Affairs, and Supplier Quality to ensure robust microbiological control throughout the product lifecycle. * Support global DS projects involving sterilization or microbiological validation * Provide technical training and mentoring for manufacturing and quality teams on sterilization and microbiological principles. F. Equipment and process Validation * Serve as the site owner for equipment and process validation activities across all manufacturing and supporting processes, in alignment with ISO 13485:2016, 21 CFR 820.70 / 820.75, and Dentsply Sirona's Global Validation Policy. * Develop, execute, and maintain validation protocols (IQ/OQ/PQ) for production and laboratory equipment, utilities, and automated systems used in manufacturing, packaging, or testing. * Partner with Engineering and Manufacturing to ensure new or modified processes are validated before release for routine production. * Ensure validation master plans, schedules, and revalidation requirements are up to date and aligned with global QA standards. * Lead or support process characterization, risk assessments, and statistical capability studies (CpK, Ppk) during validation planning and execution. * Review and approve validation documentation prepared by other functions to ensure consistency, technical adequacy, and regulatory compliance. * Maintain validation traceability and control through SmartSolve or other designated QMS systems. * Act as the primary site interface for internal and external audits regarding validation programs, ensuring readiness and documentation integrity. * Provide technical guidance and training to engineers and production teams on validation principles, documentation, and lifecycle management. EDUCATION: Bachelor's or Master's degree in Microbiology, Biology, Biomedical/Quality Engineering, or a related discipline is preferred, or an equivalent combination of experience and education. CERTIFICATIONS/LICENSING * Six Sigma is preferred * American Society of Quality - Engineer preferred * Professional Engineering Certificate preferred Years and Type of Experience: 3-5+ years of experience in sterilization validation and microbiological quality systems in the medical device or pharmaceutical industry. Key Required Skills, Knowledge and Capabilities: * Strong knowledge of ISO 13485, ISO 11137, ISO 11737, ISO 14644, and FDA 21 CFR 820. * Experience with gamma sterilization validation and environmental control programs required. * Hands-on experience with SmartSolve, TrackWise, or equivalent electronic QMS preferred. * Strong analytical, documentation, and cross-functional communication skills. * Understanding of Good Manufacturing Practices, Quality Systems, Regulatory requirements, validation principles and manufacturing methods in Medical Device regulated environment. * Understanding of inputs, outputs, raw materials, waste, quality control, costs, and techniques for maximizing the manufacture and distribution of goods. * Creative problem solving, flexibility and sound negotiation skills. * Strong project management skills as well as an ability to multi-task. * Ability to work with mathematical concepts such as probability and statistical inference, and fundamentals of plane and solid geometry and trigonometry helpful. * Ability to apply concepts such as fractions, percentages, ratios, and proportions to practical situations. * Ability to analyze, estimate and evaluate data. * Ability to apply principles of logical or scientific thinking to a wide range of intellectual and practical problems. * Ability to deal with nonverbal symbolism (formulas, scientific equations, graphs, etc.) in its most difficult phases. * Ability to deal with a variety of abstract and concrete variables. * Ability to read, analyze and interpret common scientific and technical journals, financial reports and legal documents. * Ability to write reports, business correspondence and procedure manuals. * Ability to respond internally to common inquires or complaints from customers, regulatory agencies, or members of the business community. Ability to effectively present information to top management, groups and /or boards of directors. Dentsply Sirona is an Equal Opportunity/ Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, age, sexual orientation, disability, or protected Veteran status. We appreciate your interest in Dentsply Sirona. If you need assistance with completing the online application due to a disability, please send an accommodation request to **************************. Please be sure to include "Accommodation Request" in the subject. For California Residents: We may collect the following categories of personal information in connection with the submission of your resume or application materials to us for employment, and if hired, your employment with us: identifiers (e.g., name, address, email address, birthdate); personal records (e.g., telephone number, signature, education information, criminal background information, passport number and visa information); consumer characteristics (e.g., sex, marital status, veteran status, race, disability, sexual orientation); professional or employment information (e.g., resume, cover letter, employment history, background check forms, references, certifications, transcripts and languages spoken); and inferences from personal information collected (e.g., a profile reflecting abilities and aptitudes). The above categories of personal information are collected for the following business purposes: performing recruitment and hiring services; processing interactions and transactions (e.g., to comply with federal and state laws requiring us to maintain certain records, managing the workforce); and security (e.g., detecting security incidents, protecting against fraudulent or illegal activity). For additional details and questions, contact us at **************************

This role is designed to support the APQP incorporation within GE West Jefferson. The role includes Advance Product Quality Planning, First Article Inspection, Preparation of Master Specs per S-043, Problem solving, and general shop quality tasks. **Job Description** **Roles and Responsibilities** + Ownership of Quality for an entire business unit and all associated hardware; Blisk, HPT, Spools, or Venture. The quality team will convene to determine the best location depending on candidate experience + Ownership includes both quality assurance and quality control. Includes quality assurance of products, services, manufacturing processes. Includes conformance in manufacturing, incoming goods control, product inspection, witness points, etc. + Participation in Lean transformation events to support the culture transformation currently under way within the shop + Understanding of key business drivers; uses this understanding to accomplish own work. Good understanding of how work of own team integrates with other teams and contributes to the area. + May have some autonomy to make decisions within a defined framework. Resolves issues in situations that require good technical knowledge and judgment within established procedures. Consults more senior team members for issues outside of defined instructions/parameters. + A job at this level requires good interpersonal skills and will be required to provide technical leadership to a cross-functional team + APQP incorporation **Required Qualifications** + Bachelor's Degree accredited college or university (or a high school diploma / GED with a minimum of 4 years of experience in quality Engineering and Manufacturing experience) + Minimum of 3 years of quality Engineering and Manufacturing experience **Desired Characteristics** + Demonstrated competence in MS Office + Previous Quality experience minimum 5 years + Familiar with Six Sigma practices + Experience with APQP + Experience with FAI and Quality Inspection Plans + Experience with AS9100 + Familiarity with inspection equipment + Experience with Lean practices + Experience with Root Cause Analysis + Strong oral and written communication skills. Ability to document, plan, market, and execute programs. + Humble: respectful, receptive, agile, eager to learn + Transparent: shares critical information, speaks with candor, contributes constructively + Focused: quick learner, strategically prioritizes work, committed + Leadership ability: strong communicator, decision-maker, collaborative + Problem solver: analytical-minded, challenges existing processes, critical thinker GE Aerospace offers comprehensive benefits and programs to support your health and, along with programs like HealthAhead, your physical, emotional, financial and social wellbeing. Healthcare benefits include medical, dental, vision, and prescription drug coverage; access to a Health Coach from GE Aerospace; and the Employee Assistance Program, which provides 24/7 confidential assessment, counseling and referral services. Retirement benefits include the GE Aerospace Retirement Savings Plan, a 401(k) savings plan with company matching contributions and company retirement contributions, as well as access to Fidelity resources and planning consultants. Other benefits include tuition assistance, adoption assistance, paid parental leave, disability insurance, life insurance, and paid time-off for vacation or illness. GE Aerospace (General Electric Company or the Company) and its affiliates each sponsor certain employee benefit plans or programs (i.e., is a "Sponsor"). Each Sponsor reserves the right to terminate, amend, suspend, replace or modify its benefit plans and programs at any time and for any reason, in its sole discretion. No individual has a vested right to any benefit under a Sponsor's welfare benefit plan or program. This document does not create a contract of employment with any individual. _This role requires access to U.S. export-controlled information. Therefore, employment will be contingent upon the ability to prove that you meet the status of a U.S. Person as one of the following: U.S. lawful permanent resident, U.S. Citizen, have been granted asylee or refugee status (i.e., a protected individual under the Immigration and Naturalization Act, 8 U.S.C. 1324b(a)(3))._ **Additional Information** GE Aerospace offers a great work environment, professional development, challenging careers, and competitive compensation. GE Aerospace is an Equal Opportunity Employer (****************************************************************************************** . Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status or other characteristics protected by law. GE Aerospace will only employ those who are legally authorized to work in the United States for this opening. Any offer of employment is conditioned upon the successful completion of a drug screen (as applicable). **Relocation Assistance Provided:** Yes GE Aerospace is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status or other characteristics protected by law.

The QA Coordinator - Investigations & CAPA supports site Quality Systems by executing and managing deviations, and CAPAs, compliance with FDA 21 CFR 210/211/11 and ICH Q10. This role drives timely, thorough investigations, applies root cause analysis, ensures effective CAPA implementation, Effectiveness and maintains inspection-ready documentation to uphold product quality and data integrity Reporting to: QA Supervisor Location: Plant Hours: Monday - Friday: 8:00am - 4:00pm Responsibilities/Essential Duties: Investigations and CAPA Management Leads or supports investigations for deviations, OOS/OOT events, nonconformances, and complaints to ensure timely, complete, and compliant documentation per 21 CFR 211.192 and ICH Q9/Q10. Performs structured Root Cause Analysis (5-Why, Fishbone, FMEA) to identify true root causes and prevent recurrence. Develops and manages Corrective and Preventive Actions (CAPAs) that are specific, measurable, and linked to verified root causes, ensuring implementation, verification, and documented effectiveness within defined timelines. Analyzes and trends investigation and CAPA data to identify systemic issues, recommends process or procedural improvements, and reports performance metrics to Quality leadership. Ensures all records meet ALCOA+ data-integrity standards and are inspection-ready. Promotes a culture of investigative rigor, continuous improvement, and accountability across Manufacturing, QC, and Engineering functions. Qualifications: Education & Experience Bachelor's degree in Life Sciences, Engineering, or related technical field required. Minimum 1-4 years of Quality Assurance experience in a cGMP-regulated pharmaceutical, OTC, or medical device environment. Demonstrated expertise in managing deviations and CAPAs, Experience with FDA inspections and supporting regulatory audits is highly preferred. Technical Skills In-depth knowledge of 21 CFR Parts 210, 211, 11, ICH Q7-Q10, and relevant USP chapters. Proficiency in root cause analysis tools and Six Sigma methodologies. Experience using electronic Quality Management Systems (eQMS) such as MasterControl, Veeva, or ETQ Reliance. Familiarity with data integrity requirements and ALCOA+ compliance. Key Competencies Investigative Rigor: Executes high-quality, inspection-ready investigations with accurate root cause identification. CAPA Execution: Ensures timely, effective, and risk-based corrective actions. Compliance Stewardship: Upholds data integrity and documentation standards across all QA systems. Collaboration: Works effectively across departments to align investigation outcomes with operational needs. Accountability: Tracks and deliveries on commitments with minimal supervision. Working Conditions: Primarily office-based with routine interaction in manufacturing and laboratory environments. May require off-shift or weekend support during audits, investigations, or operational escalations. Occasional travel may be required for training or supplier quality support Company Summary: Crown is a proud member of the Revance Portfolio of skincare offerings. Revance is a fast-growing global aesthetics and skincare company focused on providing innovative aesthetics and market-leading skincare offerings throughout every stage of life. With a differentiated portfolio of products spanning 60 countries, Revance meets the evolving needs of patients and consumers worldwide through continued innovation and commercialization of new products and treatments. What Revance invests in you: Competitive Compensation including base salary and annual performance bonus Paid time off, holidays, and floating holidays that can be used for whatever you choose Generous healthcare benefits, Employer HSA match, 401k match, wellness discounts and much more This section of the is required by the American with Disability Act (ADA). The ADA requires that job descriptions reflect the physical and mental demands required to effectively perform the essential duties of the job. The ADA prohibits employers from discriminating against a “qualified individual with a disability” in all aspects of the employment relationship. A “qualified individual with a disability” is “an individual who meets the education, experience, skill, and other job-related requirements of a position held or desired, and who, with reasonable accommodation, can perform the essential functions of a specified job.” Revance is an Equal Opportunity employer. All qualified applicants will receive consideration for employment based on merit, without regard to race, color, religion, sex, national origin, disability, protected Veteran Status, or any other characteristic protected by applicable federal, state, or local law.