Quality Manager

ONE TEAM. MANY TECHNOLOGIES.One TEAM. Many Technologies. TEAM is a rapidly growing end-to-end manufacturing solutions provider for our customers. With over 30 years of experience and technology, TEAM provides seamless, turnkey processes proven to positively impact customer's business.Founded in 1988 by three entrepreneurs in Morristown, Tennessee, TEAM began with a single guiding principle: TEAM will grow by partnering with our customers to drive their growth. In the spirit of our founders' guiding principles, we continue to grow by adding new technologies to broaden our capabilities and provide solutions for our customer partners. As ONE TEAM with MANY TECHNOLOGIES, we stand ready to be YOUR PARTNER FOR WHAT'S NEXT . You can find TEAM in fourteen locations across the United States and three international locations.ONE TEAM. MANY OPPORTUNITIES...Quality Manager General Duties:Responsible for maintaining an effective Quality Management System in accordance with FDA Regulations (Medical Device regulations - 21 CFR 820 and/or Pharmaceuticals 21 CFR 210-211) and ISO standards (ISO 13485:2016, ISO 9001:2015) as it pertains to Manufacturing, Engineering, Purchasing, and Customer Service. Supervise, train and assist personnel with inspections, complaint resolutions, documentation control, GMP compliance, risk analysis/mitigation, and product conformity. Working independently, monitor KPI's and implement action plans for Continuous Improvement and Regulatory compliance.Specific Duties:Ensures products are manufactured/packaged in accordance with FDA requirements, ISO standards, Customer Requirements and Supplier Quality Agreements.Review/resolve quality problems by leading Root Cause Analysis (RCA), determining Corrective Actions Preventative Actions (CAPA) and Verifying implementation.Manages Quality Laboratory and ensures testing is performed in support of QMS, regulations and business needsEnsures adherence to Standard Operating Procedures and Work InstructionsCreates/updates procedures, work instructions and formsDispositioning non-conforming product and customer returnsPerforms audits of sister sites and other departmental areasTrending and reporting complaints, non-conformances and manufacturing data related to nonconforming product and wasteReporting KPI's and implementing processes to ensure KPI targets are metLeads Customer and third-party audits at respected plantPerforms Mock RecallsCreate/provide training for plant personnelPrepares reports and other documentation required by regulatory agencies and the head of qualityMaintain Change Management program, performing risk analysis and ensuring changes are documented and approvedOversee Pest Management programMaintain Quality records both electronically and in hard copy, as requiredPerform/Assist with Machine Qualifications (IQ/OQ/PQ) and Process ValidationsMaintain nonconformance log and associated trending and chartingMaintains a positive attitude and acts as cultural change agentDemonstrated ability to work independently with limited directionAddress personnel issues, enlisting assistance as needed or requiredMake recommendations on employment decisions (e.g., hiring, disciplinary action, termination)Effectively communicate at all levelsMaintain good attendancePerform other duties and responsibilities as assigned.Qualifications/Skills Required:Experience in a GMP regulated environment (Medical Device, Pharmaceutical, Cosmetic, Food or the Packaging thereof)Experience leading Root Cause Analysis/InvestigationsAbility to lead and coach various quality, improvement and investigational tools (e.g. 5 why's, Process Mapping, FMEA, Control Plans, Fishbone, Lean Six Sigma, 8D, etc.)Experience or practical training in statistical process controlExcellent communication skills, working with internal and external customers, suppliers, and auditorsHigh proficiency in Microsoft Office suite (Excel, Word, PowerPoint)Education / Experience Required:Bachelor's degree in Chemistry, Biology, related science or Engineering disciplineThree years' experience managing Quality Management SystemsProven record of performance to job requirementsExperience with FDA audits, regulatory agency interaction, and/or ISO certification processesASQ Certifications (e.g. LSSGB, CIA, CQA, CQM, etc.) - preferredTeam Technologies is an Equal Opportunity Employer. All qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, marital status, sexual orientation, gender identity, age, physical or mental disability, or covered veteran status.