MAIN JOB RESPONSIBILITIES / COMPETENCIES
1. Support site production, operations, and quality and R&D teams by addressing emergent issues that might arise due to the operation processes. Serve as the quality representative during any product or process investigation. Lead investigations including root cause analysis and health risk assessment of the identified product or process nonconformities.
2. Prepare and execute validations, technical studies, test method validations and other studies / reports as required. This includes preparation of protocols, establishment of test methodology and acceptance criteria, training personnel, execution, data analysis, investigation, and writing final reports.
3. Initiate and lead project teams on non-conformance investigations regarding component failures, finished goods failures, and product returns. This includes but is not limited to performing risk analysis, determining root cause and recommending corrective action.
4. Conduct internal audits and supplier audits. This includes preparation of audit plans, audit reports, and verifying corrective actions have been completed and are effective.
5. Initiate and lead project teams on Corrective Action/Preventive Action (CAPA) projects. This includes, but is not limited to, performing risk analysis, root cause analysis; developing a corrective action plan, implementing the plan, and submitting a summary report for project closure and conduct effectively checks (EC).
6. Assist Complaint Handling Department with technical/engineering support regarding customer complaints and product returns. Investigation may involve reviewing manufacturing batch records, vendor component records, MRB records, etc. to determine root cause of product failure.
7. Prepare and report appropriate metrics to executive management.
8. Participate in Design Project Teams as a QA Representative to ensure that input requirements (internal, external, and customer) are clearly defined, risk assessment is performed, output meets input requirements, and objective evidence clearly supports conclusions. Additionally, ensure that quality related issues are adequately addressed. Perform quality related design control activities as assigned by Design Project Team. Partner with production during Design Transfer phase to ensure that products and processes meet all quality requirements.
9. Interface with external auditors (Notified Body, FDA, etc.) during audits at the Monrovia site; participate in the preparation and completion of corrective action plans as needed.
10. Other duties as assigned.
EDUCATION & TRAINING
• A Bachelor of Science (BS) in science or engineering, advanced degree preferred.
• Minimum two year’s experience or advanced degree with one year of experience in quality engineering in the medical device or pharmaceutical industries, including the practical application of FDA Quality System Regulation and ISO 13485 or equivalent. General knowledge of manufacturing processes such as injection molding, assembly, packaging, and sterilization required; experience in the vision care or intraocular lens industry preferred.
• Excellent understanding of quality system regulations applicable to the design, manufacture and global distribution of medical devices or drugs.
• Solid understanding of investigation techniques including design of experiments and root cause analysis.
• Demonstrated understanding and application of Quality System Auditing and Analysis
• Solid grasp of basic statistical techniques with basic understanding of advanced techniques in data analysis.
• Excellent project management, organization, writing and presentation skills required.
• Demonstrated expert knowledge of Windows-based software, including Word, Excel, Access, Project, and Power Point.
• Ability to influence and build consensus across cross-functional groups.
• Must be highly proficient in written and verbal communication.
STAAR Surgical is an Equal Opportunity/Affirmative Action employer and all qualified applicants will receive consideration without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran or disability status, or any other characteristic protected by law.