Quality Coordinator

Job Title

Quality Coordinator

Requisition

JR000014663 Quality Coordinator (Open)

Location

Madison, WI

Additional Locations

Job Description Summary

Job Description

The Quality Coordinator oversees the nonconforming material report process, including organizing material review board meetings and managing the status of quarantined and scrapped materials. The Quality Coordinator is responsible for tracking and analyzing nonconforming products to support site metrics and supplier quality assessments. The Quality Coordinator ensures all tasks align with current GMP standards and comply with established procedures to maintain the quality and integrity of the process.

• Associates degree with 3+ years' experience managing complaints and investigations with metrics in pharma/medical device industry - OR - Bachelor’s Degree with 1+ years

• Knowledge of FDA CFR 820 and ISO 13485 requirements medical device manufacturing

• High level of motivation; ability to work independently.

• Ability to communicate well, both verbally and written

• Collaborative with strong levels of engagement with individuals and as a team member

• Participation experience with internal, external and supplier audits

Preferences:

• 3+ years working in medical device industry 

• Strong Statistical background

• Auditor Certification (ASQ CQA or CMDA)

Organizational Relationship/Scope:

Reports to the Quality Control Manager. This position is accountable for delivery of prompt investigative work and detailed reporting. Working across multiple functions, this position collaborates primarily with manufacturing, engineering and quality to assess nonconforming products and support supplier quality issues.

Manufacturing facility of medical devices and accessories. Controlled environmental working conditions.

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