NEW JOB OPENING
NPI QUALITY ENGINEER - MEDICAL DEVICES
IN Irvine, CA, USA!

 

Date Posted: 07/31/2026
Hiring Organization: Rose International
Position Number: 504985
Industry: Medical Equipment & Supplies
Job Title: NPI Quality Engineer - Medical Devices
Job Location: Irvine, CA, USA, 92620
Work Model: Onsite
Shift: 8:00 AM - 5:00 PM, Monday - Friday
Employment Type: Temporary
FT/PT: Full-Time
Estimated Duration (In months): 7
Min Hourly Rate($): 60.00
Max Hourly Rate($): 70.00
Must Have Skills/Attributes: Inspection, Manufacturing, NPI - New Product Introduction, PFMEA, Quality Assurance, Quality Engineer, Research and Development (R&D), Risk Management
Nice To Have Skills/Attributes: PPAP (Production Part Approval Process)
Experience Desired: Quality Engineering or New Product Introduction (NPI) experience (3+ yrs); Experience collaborating with R&D, Advanced Operations, and Quality teams (3+ yrs); Strong knowledge of Process Risk Management (PFMEA), risk mitigation, and ISO 14971 (3 yrs); Experience developing inspection processes, inspection plans, and First Article Inspections (FAI) (3 yrs); Experience supporting Design Transfer and cross-functional product launches (3 yrs); Validation Quality Approver/Validation Representative experience (0-1 yrs); PPAP and NPI Purchasing Controls experience (0-1 yrs)
Required Minimum Education: Bachelor’s Degree

**C2C is not available**

 

Job Description
Required Education:

• Bachelor's degree in engineering, Physical Sciences, or Statistics required



Required Experience/Skills:

• Minimum 3 years of Quality Engineering or New Product Introduction (NPI) experience

• Experience collaborating with R&D, Advanced Operations, and Quality teams throughout the product lifecycle

• Strong knowledge of Process Risk Management (PFMEA), risk mitigation, and ISO 14971

• Experience developing inspection processes, inspection plans, and First Article Inspections (FAI)

• Experience supporting Design Transfer and cross-functional product launches

• Strong communication, problem-solving, and continuous improvement skills



Preferred Experience/Skills:

• Validation Quality Approver/Validation Representative experience

• PPAP and NPI Purchasing Controls experience

• Experience driving validation activities and process excellence



Job Duties:

• Support Quality Engineering activities for New Product Introduction (NPI) and product lifecycle projects

• Collaborate with R&D, Advanced Operations, and Quality teams to ensure successful product launches

• Lead Process Risk Management activities, including PFMEA, risk assessments, and mitigation plans

• Develop, implement, and improve inspection processes, inspection plans, and First Article Inspection (FAI) strategies

• Support validation activities, Design Transfer, and Process Transfer projects

• Manage PPAP and supplier quality activities for NPI

• Ensure compliance with ISO 14971 and applicable quality standards

• Drive continuous improvement initiatives to enhance quality, efficiency, and manufacturing processes



  • **Only those lawfully authorized to work in the designated country associated with the position will be considered.**

  • **Please note that all Position start dates and duration are estimates and may be reduced or lengthened based upon a client’s business needs and requirements.**


 

Benefits:
For information and details on employment benefits offered with this position, please visit here. Should you have any questions/concerns, please contact our HR Department via our secure website.

California Pay Equity:
For information and details on pay equity laws in California, please visit the State of California Department of Industrial Relations' website here.

Rose International is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex, sexual orientation, gender (expression or identity), national origin, arrest and conviction records, disability, veteran status or any other characteristic protected by law. Positions located in San Francisco and Los Angeles, California will be administered in accordance with their respective Fair Chance Ordinances.

If you need assistance in completing this application, or during any phase of the application, interview, hiring, or employment process, whether due to a disability or otherwise, please contact our HR Department.

Rose International has an official agreement (ID #132522), effective June 30, 2008, with the U.S. Department of Homeland Security, U.S. Citizenship and Immigration Services, Employment Verification Program (E-Verify). (Posting required by OCGA 13/10-91.).

 

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About Rose

  • Founded in 1993
  • Office Locations Across the U.S.
  • 150+ Clients: Corporations and Government Agencies
  • Employee Oriented Company
  • Challenging Assignments Across the U.S.
  • Continuous Professional Development

My on-boarding with Rose was outstanding. The packets of information, the process, and great attention to detail each person gave me allowed me to get started quickly.I appreciated each person's friendly and helpful attitude.

Diana, Consultant

Working for Rose International was the most pleasant assignment I have ever had. They were always on top of situations when necessary, and very helpful. I was very proud to be an employee of Rose International, and would recommend anyone to try to work with them.

Melvon, Consultant

Rose International has been great to me. I thank everyone there for all of their hard work; it has not gone unnoticed.

Melody, Consultant

I had a very positive experience working for Rose. The entire process is very efficient and easy.

Joanne, Consultant

Any time I did have a question and called, the phone was always answered, and my question/concern was immediately resolved.

Sally, Consultant

EMPLOYEE COMMENTS

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