02 NovRole Responsibilities Include:
- Manages investigations support for product NCMRs, CAPAs and Complaints.
- Managing daily quality control operations in support of manufacturing goals and company objective, including oversight of post-market regulatory review, and reporting to the appropriate regulatory bodies for escalated complaints.
- Ensures accurate documentation of the complaint evaluation and investigation results within assigned complaint records
- Manage QC testing, QC Analyst and Product Support departments
- Support developing quality systems to ensure new systems and system changes are up to date for improvements
- Responsible for meeting production schedules, supporting product transfers and V&V activities
- Ensures that investigations into product performance are compliant with all required FDA, ISO and other applicable regulatory agency standards and documentation
- Develops and initiates policies and/or procedures for continuous improvement of quality metrics
- Act as an SME for QC responsibilities in both external and internal regulatory audits.
- Ensures that the test processes are set-up and operating
Primary lead in investigations from complaints including analysis of Quality System documents and process, final review, and generate/submit reports to appropriate notified bodies
Primary lead in managing internal audit process, including performing distributor audits according to requirements and regulations
Managed the product stability program using quality metrics and performance trending activities
Provide leadership to assigned staff and supervisors by communicating and providing guidance towards achieving department objectives
- Bachelor's degree in Chemistry, Biology, Engineering, or any Life Sciences degree
- 8+ years of testing, analysis, compliant investigation, or quality control/assurance experience required
- 5+ years of experience in a supervisory/management role in laboratory environment highly preferred
- Full Knowledge/understanding of FDA regulated industry- such as ISO 13485, ISO 14971, 21 CFR Part 820, and other applicable regulations and standards
- Experience in working with semi-automated equipment
- Ability to perform laboratory operations with a high degree of skill, efficiency, and professionalism
- Understanding of manufacturing systems (documentation, compliance, inventory control, production scheduling/controls, etc.).
- Excellent written and verbal communication skills
- Understands functionality of manufacturing equipment and operating systems