Job Title:  Quality Specialist

Position Summary

The Quality Specialist is responsible for assisting in administration of the quality functions at a site to assure adherence to ISO 9001, ISO 13485, MDSAP, FDA 21 CFR Part 820/211, EU MDR and other applicable regulatory standards. This role coordinates document control transactions, site record retention, calibration and inspection activities. In addition, the Quality Specialist will facilitate Customer complaint investigations, assist in audit coordination, support supplier quality and customer assessments and support risk management activities where appropriate. This role may also track and trend Quality data and support the site Management Review process.

Duties

• Complete document control transactions.
• Manage Customer complaint investigations and complete complaint documentation.
• Facilitate CAPA and NCR investigations and may coordinate investigation documentation.
• Review DHR’s and support batch record release.
• Manage record retention practices within the site.
• Manage site calibration activities and recordkeeping.
• Support site inspection activities and recordkeeping.
• Coordinate internal and external audits.
• Support supplier quality and Customer assessment activities.
• Track and trend site Quality data.
• Support targeted Lean activities.
• Complete other duties as assigned.

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Required Experience

• Minimum of an Associate's Degree, or higher education. 
• Two (2) years of experience in Quality in a regulated industry (i.e. FDA/ISO 13485).

Skills

• Customer Focused: Demonstrates a “Customer first” mindset.  Responds with a sense of urgency.
• Teamwork: Collaborates with others. Works in a professional manner to support team actions. 
• Results: Effectively manages work tasks.  Is detail oriented and strives for continuous improvement.  Ability to analyze technical issues.  Ability to cope with change and shifting priorities.
• Communication: Constructs clear written communication.  Keeps manager and co-workers informed.
• Job Knowledge: PC experience and working familiarity of common desktop applications including Excel and Word.

Work Schedule

• This is an onsite schedule position based in Plymouth, MN. 
• The schedule is M-F, dayshift hours.