Quality Systems Specialist: Med Device QA & Compliance

Zeus Company

Arden Hills, Northern (MN, KY)

Hybrid

USD 53,000 - 68,000

Full time

14 days+
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Benefits offered by this job

Competitive pay
Great benefits package
Opportunity to join a family-oriented,

Job summary

Zeus Industrial Products in the US seeks a Quality Assurance Specialist to review deviations, ensure proper dispositioning, and maintain lot history and traceability in the eQMS. You will create parts, link records, and perform audits under Quality management direction.

Ideal candidates have a high school diploma or technical degree with 5+ years in medical device QA, plus strong data handling using Word/Excel and attention to detail for compliance and continuous improvement.

Qualifications

  • High School Diploma or two year technical degree, or 5+ years in medical device QA.
  • Ability to read and interpret documents and use Word/Excel.
  • Excellent attention to detail and organizational skills.
  • Strong problem-solving and ability to apply instructions.

Responsibilities

  • Review and monitor deviations and nonconforming material reports in eQMS.
  • Ensure disposition activities and training are completed timely.
  • Create parts in the eQMS and link to Suppliers/Customers where applicable.
  • Maintain traceability records and SOP-compliant documentation.
  • Perform audits and Gemba walks per Quality management direction.
  • Assist in equipment validation activities including verification testing.
  • Train and mentor Quality Inspectors and Technicians.
  • Ensure compliance with SOPs and CER gowning/ hygiene requirements.
  • Assist MRB for nonconforming materials and manage deviations.
  • Oversee deviations for expiration and update lot history records.
  • Maintain accurate equipment calibration and preventive maintenance program.

Skills

Interpersonal Skills
Oral and Written Communication
Teamwork
Motivation and Planning/Organizing
Professionalism
Quality
Safety and Security
Adaptability
Attendance/Punctuality
Dependability
Initiative
Innovation

Education

High School Diploma or two year technical degree

Tools

Microsoft Word
Microsoft Excel

Job description

Zeus Industrial Products in the US seeks a Quality Assurance Specialist to review deviations, ensure proper dispositioning, and maintain lot history and traceability in the eQMS. You will create parts, link records, and perform audits under Quality management direction.

Ideal candidates have a high school diploma or technical degree with 5+ years in medical device QA, plus strong data handling using Word/Excel and attention to detail for compliance and continuous improvement.

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