The Director of Quality Assurance – Medical Device directs and coordinates all quality assurance activities within an FDA regulated design and manufacturing plant, including managing a quality assurance team working under ISO 13485. All candidates should have progressive leadership experience with developing quality systems, audit, and IQ, OQ PQ, process validation. Activities will include developing, documenting, and maintaining technical business solutions or audits of data, policies, procedures, and systems to ensure compliance with Medical Device (21CFR 820s) and ISO 13485, ISO 149712 and 21CFR and other worldwide regulations.
Our medical device clients seek quality assurance leaders who are career-driven, have strong management and mentoring skills and a depth of experience in managing complex quality systems. Our companies offer excellent career growth potential and benefits. We have many opportunities – all with top medical device companies seeking on the best in quality assurance leadership.
typical roles and responsibilities for Director Quality Assurance
Responsible for managing quality systems in the successful implementation of highly technical or involved engineering projects in the creation and development of automatic, semi-automatic and manually controlled production processes
Manage corrective action teams and develop individual corrective action plans and systems.
Direct and manage the activities of quality and validation staff
Prioritize quality engineering projects and assignments for completion by the appropriate QA personnel.
Establish systems to document and maintain process validation and drawing compliance.
Responsible for the performance management and career development of direct reports and their subordinates.
Analyze internal quality systems and associated data to assure adherence to QSRs, ISO, and other international standards, Corporate quality standards, and Divisional and Facility quality standards.
Develop, review and maintain quality policies in collaboration with corporate quality
Responsible for the investigation of product and process quality and manufacturing issues.
Perform periodic complaint trend analysis and makes recommendations and reviews associated action plans for complaint reduction.
Keep the site and corporate leadership teams informed about quality-related problems and issues.
Review Corporate and ISO Quality Audit Reports and prepares appropriate corrective action responses.
Ensure compliance with Good Manufacturing Practices (GMP and ISO), safety policies, and good housekeeping and that safety and hazard practices are understood and followed.
Work to assure Quality Assurance requirements are maintained.
Work to assure regulatory compliance with pertinent outside agencies.
Requirements for Director of Quality Assurance
Bachelor’s degree, preferably in engineering or technical discipline
ASC CQE certification
10+ years’ experience in engineering with progressive and extensive experience in medical device quality assurance
Experience with Class II or Class III medical devices
Knowledge of all phases of project management
Expert working knowledge of ISO 13495, ISO 149702 and MDD
Experience managing a comprehensive quality group that includes QA, QC, validation
Lean Six Sigma certification preferred
Excellent analytical and statistical skills
Excellent communications skills and a track record of accomplishment in leading and mentoring a subordinate team