Senior Quality Engineer
Lake Forest, CA
• Develop, implement and maintain procedures for compliance to regulatory requirements, internal procedures, inspection & sampling documents.
• Develops and implements systems to improve the detection and prevention of quality failures.
• Process improvements; analyze nonconforming product/process/material issues.
• Provides guidance and training to Quality personnel and employees of the company regarding the Quality System.
• Receive, analyze and respond to customer complaints.
• Analyze complaint patterns and categories to develop strategies for company wide improvements. Participates in Quality planning- facilities and products: requirements, documentation and completion (overview/monitoring).
• Project planning/product manufacture development.
1. 1.Develop quality procedures for QMS as well as new products/processes.
2. Assist in the development of new inspection and test methods.
3. Provide feedback to QA, Operations and R&D on quality issues.
4. Assist product development team members in initiating document changes.
5. Perform gap analysis of external standards (e.g. ISO 13485)
6. 6.Integral part of project team to launch new products.
7. Lead supplier audits based on risk management process
8. Create and/or review quality and regulatory documents including protocols, reports, test methods, inspection methods, design dossier, submissions, and procedures.
9. Serve as the deputy management representative
10. Assist in submission of Medical Device Reports and Vigilance Report
1. Inspection techniques, understanding technical documentation including mechanical drawings.
2. Written and oral communications.
3. Reading technical documentation.
4. Working in controlled environments (clean rooms).
5. Good intra-personal skills.
6. Knowledge of Quality Systems for medical device manufacturing and requirements for inspection and testing.
7. Plan, document (protocol and reporting) product/process validations.
8. Performs audits of the Quality Systems, both internal and vendor. Internal audit planning, conducting, reporting (including development and completion of corrective action plans). Participate in supplier qualification activities and audits.
9. Initiates and/or verifies corrective and preventative actions resulting from NCMR’s, audit findings and customer complaints.
10. Develop and complete qualifications for new or changed materials and processes.
11. Identify/evaluate quality inspection/test equipment requirements.
12. Lead Quality Circles for process improvement/problem solving.
1. Degree in engineering related field or equivalent.
2. Minimum 5-10 years in quality control for medical device manufacturing.
3. Use of video inspection equipment (desirable) and other inspection tools.
4. Inspection sampling plans.