Location: Woburn, MA
Responsible for the general management of Operations Quality Assurance function, provides support for the Surgery Business Unit for process/product transfers, supports sustaining engineering activities to promote continuous improvement, and to assure compliance to established regulatory compliance standards and corporate standard operating procedures. Responsible for the planning, development, and implementation of quality management systems that support the Woburn Operation and Surgery Business Unit objectives and resources. Appointed as Management Representative for the site and responsible for communicating the suitability and effectiveness of the quality management system to Sr. Management with executive responsibility.
- Implements compliance program, assesses and communicates QMS risks and drives improvement processes;
- Leads management and readiness of inspections and is the regulatory agency contact for the Woburn site. Hosts and participates in third party audits (i.e. FDA, ISO, MDSAP)
- Designs and executes a periodic Quality Management Review process to assess the suitability and effectiveness of the quality management systems. Takes appropriate action for continuous improvement.
- As Quality Management System (QMS) Representative, reports on the suitability and effectiveness of the quality system to the Executive with Management Responsibility and other relevant management. This includes the authority for key quality sub-systems such as: Quality Audit programs Corrective and Preventive Action System Management of non-conformances involving product or the quality system Participates in the product assessment team and coordinates regarding resultant activities.
- Broad knowledge of quality, regulatory, technical, and business knowledge
- Demonstrated problems solving skills and decision-making acumen
- Thorough understanding of QA/QC systems and manufacturing processes.
- Strong working knowledge of GMP and ISO requirements.
Additional Desirable Qualifications Skills and Knowledge:
National Certification in CQE, CRE, CQA or CQM.
Education and/or Experience:
Bachelor’s degree in Engineering or Technical Sciences.
Minimum of 7 years experience in a federally regulated industry to include Quality Assurance and/or Regulatory Affairs.
Minimum five years supervisory experience.
Relocation assistance available