The Quality Engineer candidate will ensure compliance with FDA regulations and review U.S. based processes including inventory purchasing, processing of product at contract companies, warehousing, shipping, distribution, service and repair. Additionally, this individual with oversee any non-conforming product events, assist in the management and processing of any customer complaints and verify that the company and suppliers are complying with requirements.
- Ensure processes and procedures are in place to meet quality, business, and quality system requirements.
- Ensure generated documents, forms, reports, and processing records are properly completed.
- Conduct internal and supplier audits as required.
- Completes supplier evaluation forms and updates the ASL (Approved Suppliers List), as needed.
- Ensures QMS requirements are understood and followed by US personnel.
- As the liaison for US based customer complaints, incumbent gathers all relevant data and information, collaborates with cross-functional team for root cause analysis, corrective, and preventive actions, and ensures closed loop communication occurs with customers.
- Ensure non-conforming materials and/or products are processed and dispositioned in proper manner including conducting root cause analysis as necessary, participating in risk analysis reviews and inventory disposition decisions.
- Develop and conduct a post-market surveillance plan.
- Write, implement, and update Standard Operating Procedures and Risk Management Plan
- Conduct or participate in risk analysis activities.
- Review and update labeling, including product Instructions for Use (IFU) and related labeling.
- Oversee and ensure US based employees are trained and up to date on training requirements.
- Create, review and approve applicable Engineering Change Orders (ECO’s).
- Review service, maintenance and repair records to ensure effectiveness and compliance.
- Excellent written and oral communication skills, a positive attitude, and a proven ability to communicate effective within all levels of the organization.
- Ability to speak, read and write proficiently in English.
- Proficient in MS Office (Outlook, PowerPoint, Excel, Word).
- Ability to effectively manage time.
- Valid driver license/dependable vehicle.
- Authorized to work in the United States.
Preferred Skills & Experience
- Bachelor’s degree in Engineering or another scientific discipline.
- Minimum of three years of work experience as a Quality Engineer in the medical device industry.
- Able to lift 50 lbs (occasionally)
- Able to work in the Irvine, California office.
- Able to travel, as required.
Reports to: QA/RA Director, dotted lined to US Head of Operations
Location: Orange County, CALIFORNIA, US