Exciting opportunity for an experienced Quality Engineer to join a growing medical device company in the Irvine area. In this role, you will assist in maintenance of the Quality Management System as well as helping during external audits from the FDA, FDB and Notified Body. May also conduct vendor audits as required.
• Initiates DCOs to update, correct and streamline documents in the QMS and for the manufacturing process. • Suggests, implements projects to streamline product manufacturing and the QMS • Works with QC to improve inspections, documentation. Develops workmanships standards for the product including development of Work Instructions (CWIs). • Works with R&D, Operations, QC, Document Control for overall improvement in product quality and manufacturing operations • Works with suppliers on resolving non-conformances in raw material components, refining specifications, documentation, etc. • Manages supplier files including approval, review, re-evaluation etc. • Manages non-conforming material reports and makes suggestions for disposition, correction, corrective actions, verification of effectiveness, etc. • Determines root cause for NCRs, CAPAs, complaints, product failures, etc. • Manages CAPA system and makes suggestions for corrective actions, corrections, preventive actions, and effectiveness. Documents and closes CAPAs. • Maintains calibration schedule and calibration of equipment. Controls calibration and manages non-conforming equipment. • Reports on metrics related to the Quality Management System • Initiates, investigates complaints from the company’s products. Documents initiation, complaints, corrective action, if required. Manages complaint files. Performs decontamination of products. Handles returns on products. • Performs DHR review of documentation including label verification prior to final release of documentation • May perform or assist in design, product, process, sterilization validations, etc. .
WORK ENVIRONMENT This job operates both in a professional office environment, R&D lab, and cleanroom. This role routinely uses standard office equipment such as computers, phones, photocopiers, filing cabinets, email, etc. Work in a cleanroom or laboratory is also part of the position.
Experience as Quality Engineer in medical devices. (Medical Device start up experience is a plus)
Initiating, implementing, and maintaining a Quality Management System in accordance with ISO 13485, 21 CFR Part 820, and MDD93/42/EEC
Notified Bodies, FDA, Competent Authorities, etc.
Deciding on substantial changes required notification to regulatory authorities
eMDRs, and Vigilance Reports
NCR and CAPA closure
REQUIRED EDUCATION Bachelors or Masters degree in Science, Engineering or related discipline. Degree is a MUST Minimum Five (5) years of related medical device industry experience.