Quality Manager – Morristown, Tennessee

(On-Site Position)

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

More specifics about the role’s requirements:

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 needs
  • Ensures adherence to Standard Operating Procedures and Work Instructions
  • Creates/updates procedures, work instructions and forms
  • Dispositioning non-conforming product and customer returns
  • Performs audits of sister sites and other departmental areas
  • Trending and reporting complaints, non-conformances and manufacturing data related to nonconforming product and waste
  • Reporting KPI’s and implementing processes to ensure KPI targets are met
  • Leads Customer and third-party audits at respected plant
  • Performs Mock Recalls
  • Create/provide training for plant personnel
  • Prepares reports and other documentation required by regulatory agencies and the head of quality
  • Maintain Change Management program, performing risk analysis and ensuring changes are documented and approved
  • Oversee Pest Management program
  • Maintain Quality records both electronically and in hard copy, as required
  • Perform/Assist with Machine Qualifications (IQ/OQ/PQ) and Process Validations
  • Maintain nonconformance log and associated trending and charting
  • Maintains a positive attitude and acts as cultural change agent
  • Demonstrated ability to work independently with limited direction
  • Address personnel issues, enlisting assistance as needed or required
  • Make recommendations on employment decisions (e.g., hiring, disciplinary action, termination)
  • Effectively communicate at all levels
  • Maintain good attendance
  • Perform 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/Investigations
  • Ability 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 control
  • Excellent communication skills, working with internal and external customers, suppliers, and auditors
  • High proficiency in Microsoft Office suite (Excel, Word, PowerPoint)

Education / Experience Required:

  • Bachelor’s degree in Chemistry, Biology, related science or Engineering discipline
  • Three years’ experience managing Quality Management Systems
  • Proven record of performance to job requirements
  • Experience with FDA audits, regulatory agency interaction, and/or ISO certification processes
  • ASQ Certifications (e.g. LSSGB, CIA, CQA, CQM, etc.) – preferred

What We Offer At TEAM

At TEAM, your benefits package includes:

  • Base compensation as well as commissions.
  • Car allowance.
  • Company provided laptop, computer and cell phone.
  • Reimbursement for all travel expenses including airfare, hotel, meals, tolls, parking, and car rental.
  • Paid Time Off (PTO).
  • Group Insurance; Medical, Dental, and Vision.
  • Company paid Basic Life Insurance.
  • Company paid Long-Term Disability Insurance.
  • Access to other voluntary benefits such as life Insurance for you and your family and short-term disability insurance.
  • 401(k) Savings Plan with employer match.
  • Employee Assistance Program (EAP).
  • Company training programs.
  • Career opportunities across the United States.

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The statements in this job description reflect general details as necessary to describe the principal functions of this job, the level of knowledge and skill typically required and the scope of responsibility. It should not be considered an all-inclusive listing of work requirements. Individuals may perform other duties as assigned, including work in other functional areas to cover absences of relief, to equalize peak work periods or otherwise to balance workload. This classification specification does not constitute an employment agreement between Team Technologies, Inc. and employee. It is subject to change as the needs and requirements of the position change.

TEAM is proud to be an Equal Employment Opportunity and Affirmative Action employer. We do not discriminate based upon race, religion, color, national origin, gender (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, gender expression, age, status as a protected veteran, status as an individual with a disability, or other applicable legally protected characteristics.

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