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Quality Inspector

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Coloplast

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Location:
United States , Minneapolis

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Category:
Quality Control

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Contract Type:
Not provided

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Salary:

46960.00 - 70441.00 USD / Year
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Job Description:

Supports Value Stream by performing inspections of incoming, in-process and finished goods for implantable medical devices. Responsible for preparation and release of Surgical sterile loads. Ensure documentation and DHRs meet FDA QMSR and ISO 13485 requirements.

Job Responsibility:

  • Perform visual and dimensional inspections of materials including incoming, in-process assemblies and finished goods
  • Perform product and incoming tests, mechanical and electrical, using equipment including calipers, micrometers, microscopes, visual measurement systems, etc.
  • Responsible for inspection of electrical components including PCBA boards for visual, continuity, and functional features
  • Assist with reviewing and ensuring drawings and procedures are current
  • Verify production records for completeness and accuracy and records required for inspections, audits, and corrective actions (including device history records (DHRs) and non-conformance reports (NC))
  • Prepare and release sterile products
  • pull pyrogen and bioburden samples as required
  • Perform release of incoming materials and finished goods in ERP system
  • Segregate and disposition quarantined materials (reworks/sorts) and complete necessary documentation
  • Place material on quarantine in ERP when appropriate
  • Re-inspect quarantined material and process rejected materials and complete necessary documentation
  • Effectively work with engineers and operators to investigate and resolve production or quality issues
  • Assist production, quality, and purchasing with resolution of issues regarding incoming or in-process materials
  • Assist with calibration activities - including ensuring equipment is appropriately calibrated and out-of-calibration issues are properly addressed
  • Aid in maintaining and appropriate file records of testing and sterilization
  • Create and provide CoC’s for finished goods as requested by sales subsidiaries
  • Coloplast employees are required to conduct business to the highest ethical and professional standards
  • comply with applicable laws and regulations, the MedTech Code of Conduct, and company policies
  • Other duties as assigned

Requirements:

  • High School diploma or equivalent qualification required
  • 5+ years of quality inspection experience, preferably in a medical device environment
  • Ability to lift 20 pounds
  • Knowledge of QMSR/ISO 13485 requirements preferred but not required
  • Ability to read and accurately follow written instructions/documents
What we offer:
  • Comprehensive medical, dental, and vision insurance plans
  • Access to company sponsored wellness programs and mental health resources
  • Paid leave of absence for qualifying events
  • Generous paid parental leave for both birthing and non-birthing parents
  • Competitive 401(k) plan with company match that vest immediately
  • Financial planning services
  • Corporate discount programs for goods and services
  • Generous paid time off
  • Flexible work hours
  • Flexible work arrangement options may be available
  • Opportunities for continuous learning and career advancement through training programs, mentorship, and tuition reimbursement
  • Recognition programs to celebrate achievements and contributions, including peer recognition, bonuses, awards, and special events
  • A supportive work environment
  • Participate in team-building activities, volunteer opportunities, and company-sponsored events

Additional Information:

Job Posted:
April 10, 2026

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