A global Medical Device company in Irvine, CA is looking to identify and hire a Quality Engineer who will be working in a dynamic and fast paced environment. The individual is responsible for driving quality engineering processes and quality assurance activities as part of a cross functional team that includes: Sustaining R&D, Manufacturing, Operations, Regulatory Affairs, Marketing and other functions to drive technical decisions, product failure investigations, and project schedule associated with disposable and electronic products. This position will provide opportunities for advancement within our growing organization. We are looking for an individual who has strong technical and communication skills, initiative, and ability to work with cross functional teams.
The Quality Engineer will be responsible for but not limited to:
Skills & Qualifications:
- Making recommendations regarding design control activities for product design and design iteration appreciating cross functional implications.
- Supporting Design Control deliverables for existing products (FMEA's, Risk Management Plan and Report, Design and Project Plan, etc.)
- Maintaining regulatory and quality compliance.
- Leading quality systems maintenance and improvement effort.
- Providing QE support on root cause analysis for complaints, CAPA and other quality related investigations. Support the investigation of product failures, Product disposition, Product Risk Assessment, NCRs, Stop Shipments, RMC, Quality Board, FCA.
- Performing Design of Experiments, analyzing data effectively, and setting direction for new experimentation.
- Leading the team in the use quality systems and statistical techniques.
- Willing to work in a dynamic environment to meet the needs of the business.
- Up to 25% travel
- Bachelor's degree in Engineering and a minimum 3-5 years' experience required OR a Master's degree and minimum of 1 year experience.
- Medical device or Pharmaceutical industry experience required.
- Knowledge and experience in Quality Systems, solutions and processes is required.
- Excellent communication skills, both written and spoken.
- In-depth root cause analysis and technical writing skills.
- Robust statistical skills and analytical thinking.
- Excellent team player.
We are an equal opportunity employer and make hiring decisions based on merit. Recruitment, hiring, training, and job assignments are made without regard to race, color, national origin, age, ancestry, religion, sex, sexual orientation, gender identity, gender expression, marital status, disability, or any other protected classification. We consider all qualified applicants, including those with criminal histories, in a manner consistent with state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance.