Careers that Change Lives
Our Class II/III Medical Device Business is looking for a Senior Quality Systems Manager to ensure a mature and compliant quality management system. You will lead a team to manage day to day maintenance of the quality management system but also to develop quality programs that ensure compliance with policies and that the performance and quality of services conform to established internal and external standards and guidelines.
A Day in the Life
Responsibilities may include the following and other duties may be assigned.
- 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 internal and external standards and guidelines.
- Provides expertise and guidance in interpreting policies, regulatory and/or governmental regulations, and internal regulations to assure compliance.
- Works directly with operating entities to provide process analyses oversight on a continuing basis to enforce requirements and meet regulations.
- Leads audit and inspection preparation, resolution of audit and inspection findings and liaises with auditing groups and inspectors through all stages of the audits.
- Prepares reports and/or necessary documentation (ex Corrective and Preventative Actions) and provides to applicable stakeholders, both internal and external.
- 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
- Bachelors degree required
- Minimum of 7 years of relevant experience with 5+ years of managerial experience, or advanced degree with a minimum of 5 years of relevant experience with 5+ years of managerial experience
- Leadership experience - leading people, staff, projects at high levels
- FDA, 21CFR820 (or 21 CFR 820), EU MDR, MDD, MDSAP, ISO 13485, Medical Device experience a must
Nice to Have
- Program Management expertise
Lean six sigma certification