Provides leadership and support for maintaining effective CAPA process, Internal Audit Process, Failure Investigation process, management reviews as well as management of control of external standards.
- Ensure that the Quality System is run by current regulation 21 CFR 820, 803, 806 and ISO 13485 requirements and other applicable standards and regulations.
- Management and administration of Management Review Committee (MRC) meetings.
- Responsible for Failure Investigation Process. Ensure that Failure Investigations are issued as required, properly conducted, documented, and linked to the CAPA process as appropriate
- Responsible for managing compliance to applicable External Standards, technical specifications and codes. Ensure that applicable Standards Assessments are conducted, documented and completed on time.
- Lead the development, maintenance and rolling review of compliance systems. Ensure compliance to Global Quality procedures.
- Coordinates Maquet-Wayne’s response to External Audits, i.e. FDA Inspection, Corporate Audits, etc.
- Provides leadership and guidance to direct reports.
- This is not an inclusive list of job responsibilities.
Required Skills and Abilities:
- A Bachelor’s degree in Engineering, Science or related field is required. A Master’s of Science in Engineering, Science or related field is preferred. CQE (Certified Quality Engineer) or CQA (Certified Quality Auditor) is desirable.
- A minimum of five years’ experience in quality assurance, quality engineering or related functions or a M.S. plus 3 years’ experience is required. Prior experience in a FDA regulated industry or ISO certified organization
Experience and Education Requirements:
- Must have demonstrated proficiency in statistical analysis, the ability to analyze and solve complex problems, and the ability to communicate effectively across departments.
- Working knowledge of quality systems is required. Familiarity with analytical software applications is preferred.
- Project management and leadership experience is required. Previous experience supervising technicians and conducting and participating in FDA/customer/corporate audits is preferred.
- Must demonstrate effective influencing and change management skills and demonstrated achievements in process improvements.
- Ability to use Microsoft Office Products such as Word and Excel or equivalent software applications is preferred.