Job Title —Engineer, at Vastek Inc.
Company —Vastek Inc.
Location —San Diego, California.
Job type —Full-time.
Required Qualification & Experience:
- Create and maintain risk management deliverables (Risk Management Plans/Reports, FMECAs, Post-Market Surveillance Reports, Periodic Safety Update Report, Risk Management Plans/Reports) in compliance to internal and external requirements including new EU MDR requirements.
- Support Regulatory Affairs by providing quality input for Clinical Evaluation Reports, Technical Documentation, and notified body submissions.
- Participates in corrective/preventive action teams to resolve systemic issues. Partners with cross-functional peers to resolve product performance issues (NCRs, CAPAs, deviations, manufacturing process problems etc.) and to assess impact on device quality and product availability..
- Partner with external suppliers to review and assess any design or process changes that may impact the product specifications or overall performance.
- Participates in product development process to include design verification, design validation, process validation and other activities as needed.
- Designing, writing and support implementing a full validation process and Equipment Qualifications (IQ, OQ, PQ)s.
- Developing Master Validation Plan (MVP), Process Failure Mode Effects Analysis (PFMEA), Qualification Documents, Validation Summary Report (VSR) and Requirements Traceability Matrix (RTM).
Vastek requires its applicants to have at least a bachelors degree or higher in an engineering discipline such as industrial engineering, Mechanical engineering, manufacturing engineering, engineering management, or a closely related filed.
Send resume to attn:
Daniella Loza, VAStek, Inc. 1230 Columbia Street, Suite 1180, San Diego, CA 92101(refer to job title).