Quality Assurance Supervisor

  * This position may be available at other SRI locations

 

 

 

SUMMARY

Key member of management team will manage total quality program, policies, and initiatives. Responsible for identifying, analyzing, reporting, and developing improvement in productivity, quality and customer relationships, and customer service.



JOB FUNCTIONS

1. Perform final quality assurance review and release of all products manufactured, assembled, and/or distributed by the facility.



2. Guide and direct Quality Assurance Technicians, conduct employee performance reviews and recommend wage adjustments.



3. Monitor and ensure compliance with quality assurance program established by the company to meet FDA and other applicable regulatory guidelines.



4. Maintain Product Complaint System at facility level. Responsible for communicating corrective action responses to customers.



5. Complete and maintain accurate records of all Quality Assurance programs required by GMP and established company procedures.



6. Document and investigate non-conformance issues at the facility, ensuring that appropriate corrective measures are implemented.



7. Interface with Operations and Engineering to assure Q. A. aspects are addressed with equipment changes/modifications.



8. Conduct GMP and other training programs as required.



9. Performs periodic Quality Systems audits, and generates audit reports.



10. Generates reports and data analysis as required by Director of RA/QA.



11. Other duties as assigned.



QUALIFICATION REQUIREMENTS

Education:

B.S. degree desired. Sufficient experience in Medical device, pharmaceutical, food/beverage Q. A. or other FDA regulated industries may be considered a substitute for education.



Experience:

Two years experience working in a Medical device or quality related field required. Experience working with device GMP preferred. Proficient with word processing and spreadsheet programs including some basic charting, graphing and data compilations.



Skills and Abilities:

1. Excellent verbal, written communication and mathematical skills required.



2. Ability to manage time and work under pressure with minimal supervision.



3. Ability to interface with all levels of management.



4. Ability to understand and interpret written requirements to assure adherence to documented procedures.



5. Experience in problem solving and root cause analysis.



6. Ability to interpret and implement device GMP?s.



7. Lean Six Sigma experience preferred.



8. Certified Quality Auditor and or Engineer preferred.



9. Must be a team player.



Physical Activities:

Standing, walking, talking, hearing, sitting, reaching, grasping, pushing, and pulling.