Summary of Position with General Responsibilities:
The position Quality Assurance Manager will be responsible for the general management of the Woburn Operations Quality Assurance function to assure compliance to established standards of corporate objectives and regulated agencies for industry (ISO and FDA). This individual will also be responsible for the planning, development, and implementation of quality systems that support the Woburn Operations and Davol business objectives and resources. Incumbent will be the appointed ISO management representative and JAPL Engineering Manager for management team.
Essential Job Functions:
- Support the facility as a Quality Management System (QMS) Representative.
- Development, implementation, and maintenance of quality systems to assure FDA, ISO, and JPAL compliance.
- Optimize quality systems to effectively identify measure and reduce cost of quality activities.
- Identify, support, and develop departmental resources to achieve business and quality objectives.
- Coordinate all facility audits (FDA, ISO, JPAL, Corporate, OEM customer).
- Review and approve Engineering changes to product; processes and materials.
- To promote and support multi-discipline teamwork, i.e., activities that support the Woburn/Davol management system inclusive of strategic initiatives and tactical plan.
- Coordinate management review periodically to assess quality system.
- Special projects as assigned.
• Bachelor Degree in Engineering or Technical Science required.
• Minimum of ten years experience in a federally regulated industry to include Quality Assurance and/or Regulatory Affairs.
• Minimum five years supervisory experience.
• Strong working knowledge of GMP and ISO requirements.
• Strong working knowledge of statistical quality tools.
• Strong oral and written communication skills.
• Strong working knowledge of applications related to SPC, Process Validation, and FMEA.
Additional Desirable Qualifications Skills and Knowledge:
- National Certification in CQE, CRE, CQA or CQM.
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