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Sr Quality Engineer ( Sr Quality Systems Specialist)
2350 West Medtronic Way Tempe, AZ 85281 US
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:
- 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
- Ability to work independently and provide comprehensive feedback on complex issues; support risk assessment processes for manufacturing and development
- 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
Equal Opportunity Employer: We are proud to be an equal opportunity employer. We welcome and encourage applications from all qualified candidates regardless of race, sex, gender identity or expression, disability, age, religion or belief, sexual orientation, or any other characteristic protected by applicable laws and regulations. It is our policy not to discriminate against any applicant or employee, and we are committed to fostering a diverse, inclusive, and respectful work environment across all locations in which we operate. We believe that diversity, equity, and inclusion are fundamental to our mission and enhance our ability to serve clients globally. If you have a disability or require any reasonable accommodations during the application or interview process, please inform your recruiter or contact us directly so that we can explore the appropriate arrangements.
Fraud Alert: Candidate safety is a top priority at Planet Pharma. The 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, never provide banking information during the application process and always double check the email address of the Recruiter to ensure it’s from an official Planet Pharma domain (@planet-pharma.com, @planet-pharma.co.uk, and @ppgadvisorypartners.com) and not a domain with an alternative extension like .net, .org or .jobs.
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