Job Description

READ FIRST! HARD REQUIREMENTS/NON-NEGOTIABLES:

1. MUST have 7+ years of Quality Engineering experience in the  medical device industry
2. No H1B Visa Sponsorship
3. Must be able local to the Irvine, CA area, no relocation support
4. Must have a BS in Engineering, Physical Sciences or equivalent

IF YOU MEET ALL FOUR (4) REQUIREMENTS ABOVE, PLEASE CONTINUE BELOW:



About the Role:

We are seeking a skilled and experienced Senior Product Quality Engineer – NPI to join our Client's team. The ideal candidate will have a minimum of 7 years of quality engineering experience with an emphasis on NPI and Sustaining Engineering in the medical device industry. This role is critical to ensuring the performance, reliability, and sustainability of all devices manufactured by the client.

Essential Duties and Responsibilities:

• Participate in design and manufacturing reviews.
• Generate DFMEAs/UFMEAs and participate in risk analysis discussions.
• Develop inspection strategy and methods to support the development and launch of new products.
• Review and approve design and development documentation.
• Serve as subject matter expert for design quality in ISO and FDA audits.
• Author procedures and work instructions that define and govern the quality system.
• Conduct internal audits of the quality system and other business functions.
• Evaluate nonconforming material and disposition based on cross-functional engineering review.
• Assure compliance to internal and external specifications and standards (i.e. GMP, ISO, FDA, MDD).
• Review trends in device failures associated with customer complaints and nonconforming material.
• Lead and own corrective and preventive actions and complaint investigations.
• Work on complex special projects as assigned.

Education and/or Work Experience Requirements:

• Bachelor's degree in Engineering or Physical Sciences is required.
• 7+ years of experience in the medical device industry.
• Proficient in technical report writing and review.
• Experience with design controls, risk management, statistics, test method validation, and new product development processes.
• Experience with industry regulations such as ISO13485 and FDA QSR’s.
• Advanced knowledge of ISO 14971 and risk management principles.

Additional Requirements:

• Excellent verbal and written communication skills – including the ability to contribute technically to and work within cross-functional team environments.
• High personal/professional integrity, trustworthiness, strong work ethic, and ability to work independently.
• Ability to work in a dynamic and collaborative environment and maintain a results-oriented, positive, “can-do” attitude and ability to work well under pressure.
• Strong organizational and multitasking skills, with a high level of attention to detail and proactive approach to problem-solving.
• Proficiency in Microsoft Office Suite (Outlook, Word, Excel, PowerPoint).

Bonus Points:

• Prior startup or early-stage company experience.
• Familiarity with Microsoft Teams.

Physical Requirements:

• Must be able to lift up to 20 lbs.
• Must be able to work extended amounts of time standing or sitting based on projects and priorities.

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