We are seeking a Post Market Quality Engineer to manage medical device complaint investigations.
This role ensures timely failure investigations, root cause analyses, and risk assessments for product field failures while maintaining compliance with medical device regulations.
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.
Send your resume to emmaemmert@spherion.com for immediate consideration!
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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 Callcenter@spherion.com.
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).