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Sr Quality Engineer ( Sr Quality Systems Specialist)

Tempe, AZ 85281

Posted: 04/07/2025 Employment Type: Contract Job Category: Engineering Job Number: 618453 Is job remote?: No Country: United States

Job Description


 

What product line will this person support? Wafer and Sensor Operations and Hybrid product lines

 

In this Sr Quality Systems Specialist for Operations Quality you will have responsibility for the Quality and Compliance of process development and manufacturing of implantable electronic products at the Tempe Campus.

Responsibilities may include the following and other duties may be assigned.
  • Ensure internal quality processes, procedures and systems are compliant to all governing standards.
  • Support manufacturing development and continuous improvement as the Quality team member for process development and validation including Equipment Development, IQ, Process Characterization, OQPQ and Test Method Development and Validation.
  • Use knowledge of statistics on acceptance criteria, DOE and comparison testing to support manufacturing engineers in the development of compliant test plans and reports.
  • Support risk assessment processes for manufacturing and development including process FMEA and design FMEA, ensuring risk assessments are thorough and documentation meets all governing requirements.
  • Support CAPA investigations, improvements, and effectiveness verification testing
  • Lead and/or support investigations of non-conforming product, materials, or processes through the coordination of cross functional teams while simultaneously

 

Top 3 technical  skills that are required for the role:
  1. Strong understanding of operations/manufacturing processes and products; Develop and support solutions for monitoring and reporting as well as taking appropriate action based on quality metrics
  2. Ability to work independently and provide comprehensive feedback on complex issues; support risk assessment processes for manufacturing and development
  3. Strong Communication Skills (verbal and written)

Education Required:  Bachelor’s degree

Years’ Experience Required: 4+ years’ work experience

 
TECHNICAL SKILLS
Must Have
  • Strong background in Equipment Development, IQ, Process Characterization, OQPQ, and Test Method Development and Validation.
  • Strong understanding of regulatory requirements (i.e.: ISO, FDA-GMP, etc.)

Nice To Have
  • Experience with electronics manufacturing including wafer fabs and electronicsassembly.
  • Six Sigma or DRM certification
  • Strong statistical analysis techniques

The staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly and never provide banking information during the application process. Candidate safety is a top priority at Planet Pharma.

Planet Pharma is an equal opportunity employer. It is our practice not to discriminate against any employee or applicant based on any criteria, condition or basis protected by laws or regulations in the locations where we do business. All qualified applicants are encouraged to apply. We celebrate diversity and are committed to providing an environment of mutual respect. We believe that diversity, equity and inclusion enable us to better meet our mission and values while serving our clients across the globe. If you have a disability or handicap and would like us to accommodate you in any reasonable way, please inform your recruiter, or contact us, so that we can discuss the appropriate alternatives available.

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About Tempe, AZ

Ready to take your career to the next level? Explore our job opportunities in the vibrant area surrounding Tempe, Arizona. Known for its dynamic job market, stunning desert landscapes, and year-round sunshine, Tempe is an ideal place for professionals seeking growth and opportunity. Home to Arizona State University, iconic landmarks like Hayden Butte Preserve, and cultural hotspots like the Tempe Center for the Arts, this area offers a blend of outdoor adventures, diverse cuisine, and a thriving arts scene. Whether you're into hiking at Papago Park, catching a show at the Tempe Improv, or cheering on the ASU Sun Devils, Tempe has something for everyone. Don’t miss out on the chance to build your career in this dynamic and thriving region. Explore our listings today and discover your next career move in Tempe!

Although this hasn't been an issue at Planet Pharma, the staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly and never provide banking information during the application process. Candidate safety is a top priority at Planet Pharma.