Quality Engineer



Advert ID



Lake Forest

Job Type




Salary Range

Based on Experience

No. of Openings


Branch Information

Southern California Engineering - (USA) 2100 Main Street 4th Floor CA Irvine , CA 92614



Job Description

Manpower Engineering is seeking candidates for the permanent opportunity of a Quality Engineer for our client who is an innovative developer and manufacturer of medical devices for more than 30 years in Lake Forest, California.

What you will be doing:

* Initiate and lead the development and review of validation policies, master plans and schedules, and protocols and quality engineering issues.

* Support site production and engineering functions in process quality improvement activities.

* Preparation of audit schedule and audit assignments, training auditors, conducting audits, and monitoring the performance of the audit process, as appropriate.

* Perform internal and supplier audits as required.

* Support the risk documentation process, ensuring that product FMEAs, Hazard assessments, etc. are regularly updated as required.

* Contribute in the investigation process, technical troubleshooting, FMEA, hazard, or other risk analysis, determining root cause and recommending CAPA/SCRs.

* Participate in Design Control on New Product development teams including advising the team on design control requirements and then develop, review and approve design control deliverables related to quality engineering and validations.

What you will need:

* Bachelor's degree in Engineering or sciences or equivalent combination of education and experience. Advanced degree preferred.

* 3+ years of experience in validation in the medical device or pharmaceutical industries including the use of FDA Quality System Regulation and ISO 13485.

* Understanding of manufacturing processes such as injection molding, assembly, packaging, and sterilization required.

* Knowledgeable about regulatory/compliance/validation issues, be self-motivated, intelligent and reliable.

* Experience in writing technical documents, especially compliance, validation and quality assurance documents and protocols will be required.