Quality Engineer

About the role

This position is central to maintaining the compliance of various aspects of the Quality Management System (QMS) in close collaboration with a small team. In all actions, this role demonstrates a primary commitment to patient safety and product quality.

Responsibilities

• Supplier Management:
  • Perform supplier controls: performance monitoring and trending, credential reviews, audits, evaluations, and establishing agreements.
  • Set risk-based sampling plans for receipt inspection procedures.
  • Manage Uromedica’s supplier management system.
• Document Coordination, Reviews, and Approvals:
  • Originate, coordinate, and review formal Document Change Reviews (DCRs) in the Grand Avenue Software (GAS) quality management software platform.
• QMS Training Coordination:
  • Coordinate training tasks.
  • Deliver training presentations, collect and grade training quizzes.
• Complaint Handling and Returned Goods Authorizations (RGAs):
  • Manage Uromedica’s complaint handling module including entering, investigating, reporting, and trending complaints.
  • Enter complaint information into post-market surveillance data.
  • Issue and track RGAs, coordinate returns with sales and marketing.
  • Perform returned device evaluations.
• Corrective and Preventative Actions (CAPAs):
  • Perform CAPA investigations, root cause analyses, corrections, corrective/preventative actions, and verifications of effectiveness.
• Non-Conforming Materials (NMRs):
  • Issue and approve NMR dispositions including risk assessments and rework instructions.
• Audits:
  • Participate in notified body, FDA, and internal audits, including audit responses.
• Management Review:
  • Data analysis and summary, slide preparation, and slide delivery.
• Review device history records to ensure records are completely and accurately filled out.
• Perform gap assessments.
• Assist manufacturing/operations projects as needed.
• Field actions: participation with Health Hazard Assessments and execution of Field Action activities.
• Conform with Coloplast Code of Conduct and all local Compliance Standards.
• Conform with Coloplast Q/EHS Policy.
• Other duties as assigned.

Requirements

• B.S. degree in engineering or other applicable discipline or applicable experience/certifications.
• Minimum 1-3 years applicable experience in medical device quality management systems.
• Working knowledge of medical device regulations (Regulation 2017/745 (EU MDR), US 21 CFR Part 820).
• ASQ Certified Quality Engineer preferred.

Skills

• Working knowledge of ISO 13485.
• Experience with Grand Avenue Software (GAS) Electronic Quality Management System (Preferred).
• Capable of independent self-led initiative in a dynamic work environment.
• Demonstrated ability to work in a team environment.
• Proficient knowledge of internet and Microsoft Office Applications (Word, Excel, and PowerPoint required; Access, Project and Visio preferred).
• Excellent attention to detail.
• Excellent oral and written communication skills.

Benefits

• Health and Wellness:
  • 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.
• Financial Security:
  • A competitive 401(k) plan with company match that vests immediately.
  • Financial planning services.
  • Corporate discount programs for goods and services.
• Work-Life Balance:
  • Generous paid time off.
  • Flexible work hours and flexible work arrangement options.
• Professional Development:
  • Opportunities for continuous learning and career advancement through training programs, mentorship, and tuition reimbursement.
• Recognition and Rewards:
  • Recognition programs to celebrate achievements and contributions, including peer recognition, bonuses, awards, and special events.
• Community and Culture:
  • A supportive work environment where everyone feels valued and has a sense of belonging.
  • Team-building activities, volunteer opportunities, and company-sponsored events.
  • Sustainability strategy outlining ambitions for running the company in a more sustainable way.

Pay

The compensation range for this position is $88,372 - $132,558. Actual compensation is influenced by a variety of factors including but not limited to skills, experience, qualifications, and geographic location. Hired candidates may be eligible to receive additional compensation in the form of bonuses and/or incentives.