POST MARKET QUALITY ENGINEER

Spherion Staffing, LLC; Warsaw (IN); On-site; USD 85,000 - 110,000; Full time

Job summary

Spherion Staffing, LLC seeks a Post Market Quality Engineer to manage medical device complaint investigations and ensure regulatory compliance.

The role focuses on cross-functional investigations, root cause analysis, and maintaining documentation aligned with 21 CFR 820, ISO 13485, and ISO 14971. Strong ASQ/ISO certifications are preferred, with 5+ years of relevant experience.

Qualifications

• Bachelor’s degree in an Engineering discipline or equivalent quality experience.
• Strong working knowledge of medical device regulations and standards (e.g., 21 CFR 820, ISO 13485, ISO 14971).
• Proficiency with GD&T, statistical process control (SPC), non-destructive testing, and measuring methods.

Responsibilities

• Investigate device field complaints with cross-functional teams and perform failure analysis using test equipment and software
• Conduct root cause analyses, complete post-market risk assessments, and maintain complaint documentation
• Review internal and external records (e.g., device history records, inspection reports) for compliance
• Maintain and update investigation Job Aids, Work Instructions, and risk management documentation
• Support quality leadership and interface with external auditors as needed

Skills

Medical Device Quality

ISO 13485 Audit Certification

ASQ Certification

Education

Bachelor’s degree in Engineering or equivalent quality experience

High School

Job description

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We are seeking a Post Market Quality Engineer to manage medical device complaint investigations.

What's in it for You?

• Competitive salary and comprehensive benefits package
• Opportunity to work in a collaborative, innovative environment
• Professional growth and skill development in medical device quality systems

Responsibilities

• Investigate device field complaints with cross-functional teams and perform failure analysis using test equipment and software
• Conduct root cause analyses, complete post-market risk assessments, and maintain complaint documentation
• Review internal and external records (e.g., device history records, inspection reports) for compliance
• Maintain and update investigation Job Aids, Work Instructions, and risk management documentation
• Support quality leadership and interface with external auditors as needed

Working hours: 8:00 AM - 5:00 PM

Skills

• 5+ years of Medical Device Quality experience
• ISO 13485 Audit Certification
• ASQ Certification

Education

• High School

Experience

• 1-4 years

Qualifications

• Bachelor?s degree in an Engineering discipline (or equivalent quality role experience)
• Strong working knowledge of medical device regulations and standards (e.g., 21 CFR 820, ISO 13485, ISO 14971)
• Proficiency with GD&T, statistical process control (SPC), non-destructive testing, and measuring methods
• Excellent written/verbal communication skills and analytical problem-solving abilities
• Proficiency in Microsoft Office (Excel, Word, Outlook, PowerPoint)
• Valid driver's license

Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.

At Spherion, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require a reasonable accommodation to make your application or interview experience a great one, please contact [e-mail].

Pay offered to a successful candidate will be based on several factors including the candidate's education, work experience, work location, specific job duties, certifications, etc. In addition, Spherion offers a comprehensive benefits package, including: medical, prescription, dental, vision, AD&D, and life insurance offerings, short-term disability, and a 401K plan (all benefits are based on eligibility).