Quality Engineer

About the role

The Quality Engineer supports Electromed’s supplier quality execution, nonconforming material management, complaint processing, complaint investigation support, and product quality trending activities. This role partners closely with suppliers, Operations, Regulatory, Design Assurance, and Document Control to identify, investigate, and resolve quality issues affecting incoming materials, released product, and field performance.

Responsibilities

• Supplier Quality / Incoming Quality:
  • Collaborate with suppliers to resolve root cause(s) of nonconforming material.
  • Administer the MRB (Material Review Board) process for determining disposition of rejected nonconforming material.
  • Maintain supplier quality performance metrics and scorecards.
  • Lead or participate in periodic re-evaluation and audit of suppliers.
  • Support supplier corrective action activities and follow-up, as assigned.
  • Analyze incoming quality data and nonconforming material trends to identify recurring issues, risks, and opportunities for improvement.
  • Support supplier-related investigations and provide technical input when supplier issues may affect field performance or complaint trends.
• Product Quality / Complaint Support:
  • Process customer complaints in accordance with established complaint handling procedures.
  • Review, investigate, analyze, summarize, and report on complaint-related quality issues in partnership with the complaint handling program owner.
  • Evaluate complaint information for potential linkage to supplier quality issues, incoming material issues, or manufacturing-related product quality concerns.
  • Conduct complaint and product quality trend analysis and escalate significant findings to appropriate stakeholders.
  • Participate in root cause investigations, risk evaluations, and corrective action activities arising from complaints and product quality issues.
  • Collaborate with post-market members on complaint-related assessments, reportability support, and follow-up activities, as needed.
  • Support complaint handling and related records during internal and external audits.
• Product Quality / Quality Systems Support:
  • Analyze data obtained from nonconforming material activity, complaints, inspection results, or other quality inputs to identify unfavorable trends.
  • Collaborate with cross-functional teams to support updates to risk management files, as needed.
  • Participate in CAPA, deviation, nonconformance, and quality improvement activities.
  • Create or edit QMS work instructions and related controlled quality documentation, as assigned.
  • Directly participate in notified body, FDA