A Day in the Life:
- Provides oversight for the development and maintenance of quality programs, systems, processes and procedures that ensure compliance with policies and that the performance and quality of services conform to established standards and agency guidelines.
- Provides expertise and guidance in interpreting policies, regulatory and/or governmental regulations, and agency guidelines to assure compliance.
- Works directly with operating entities to provide process analyses oversight on a continuing basis to enforce requirements and meet guidelines.
- Leads audit and inspection preparation, resolution of audit and inspection findings and liaises with auditing groups and inspectors through all stages of the audits.
- Co-ordinates legal requests in support of government investigations or litigations.
- Ensures the quality assurance programs and policies are maintained and modified regularly.
- Facilitates uniform standards worldwide and enables best practice sharing, thereby fostering the achievement of company's mission globally.
Must Have: Minimum Requirements
- Bachelor's degree
REQUIREDYEARS OF EXPERIENCE:
- 7+ years of quality or manufacturing experience
- 5+ years management experience
- 7+ years experience in GMP medical device environment
- Working knowledge of Quality System Regulation (QSR 21 CFR 820), Canadian Medical Device Regulation (CMDR), EU Medical Device Directive (EU MDD 93/42 EEC), and ISO 13485:2003
- Internal and external auditing
- Corrective Action
- Process Improvement Methodology
- PC skills, work processing, spreadsheets, project management, etc.
- ASQ certification
- Effective verbal and written communication, analytical, influencing and interpersonal skills
- Must be able to communicate at all levels and across company lines
- Advanced degree in business or engineering.
- 3+ years Quality Assurance experience in a QSR (GMP), disposable medical device environment
- Presentation and training expertise