Senior Manager Quality Systems
Senior Manager Quality Systems
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Not Disclosed
Salary Not Disclosed
1 Vacancy
Job Description
- Hosts External Audits demonstrating Nalu quality management system compliance to external regulators for ISOCFR 820 and other countryspecific regulatory requirements.
- Conducts Internal Audits to assess the compliance of Nalu quality management system in accordance with ISOCFR 820 and other countryspecific regulatory requirements.
- Strong knowledge of Corrective Action System leading root cause investigation and corrective action planning in response to external and internal audit observations in collaboration with departmental process owners and subject matter experts.
- Responsible for Training Program and compliance to internal and external requirements.
- Oversee Document Control including change management process.
- Maintains expertise in both current and emerging regulations and standards impacting Nalu medical device products.
- Team member for regulatory compliance assessments to support the decisionmaking in critical business decisions including Product Actions.
- Analyzes & interprets quality system performance metrics presenting to Top Management as part of Management Reviews.
- Program manage initiatives intended to improve the Nalu quality management system.
Qualifications
- Bachelors degree preferably in engineering physical science (e.g. Chemistry) life science (e.g. Microbiology or Biology).
- Minimum of 8 years of industry experience in a medical device regulated environment.
- ISO 13485 Lead Auditor certification by a professional body is preferred.
- Quality Assurance Quality Control or Regulatory background in a medical device regulated environment is required.
- Thorough documented understanding/knowledge of FDA 21 CFR 820 and ISO 13485 standard.
- Regulatory inspection experience preferably with direct agency inspector interaction.
- Strong project management skills.
Required Experience:
Senior Manager
Employment Type
Full Time
