Quality Technician

REQ Solutions; Saint Paul (MN); On-site; USD 42,000 - 58,000; Full time

Job summary

REQ Solutions is seeking a Quality Technician II (Medical Device) for an onsite, first shift role in Saint Paul, MN. The position focuses on processing and trending return product complaints for Cardiac Rhythm Management devices, with investigations of returned pacemakers and cross-functional collaboration.

The role requires a HS diploma/GED, 1+ year of related experience, and strong MS Word/Excel/Outlook skills along with solid technical writing capabilities.

Qualifications

• HS diploma or GED required.
• 1+ year of related experience.
• Proficient in Microsoft Word, Excel, and Outlook.
• Solid technical writing skills.

Responsibilities

• Process and trend cardiac rhythm management return product complaints.
• Investigate returned pacemakers and conduct analyses.
• Collaborate with a cross-functional team including R&D and Manufacturing.
• Maintain compliance with quality requirements and training.
• Enter complete, accurate information into the GCMS complaint database.
• Ensure product traceability for all products received and analyzed.
• Assist in updating returned product test procedures.
• Identify opportunities to improve complaint-handling processes and procedures.
• Maintain lab cleanliness and comply with procedures and standards.

Skills

Technical writing

MS Office proficiency

Electrical basics understanding

Education

HS diploma/GED

Tools

GCMS Trackwise

Job description

Job Title: Quality Technician II (Medical Device)

Duration: 12+ Months (Possible temp to hire)

Onsite Role

1st Shift (6:00AM - 2:30PM)

Responsibilities:

• The primary purpose of the position is to ensure Cardiac Rhythm Management return product complaints are processed, reported and trended timely and accurately.
• The primary responsibility of this role is to investigate returned pacemakers and conduct analyses based on the reported complaint.
• Will collaborate with a broader group of approximately 20 individuals, including an immediate team of about 10.
• Maintain compliance with applicable quality requirements, including completing required training and documenting training as needed.
• Receive and verify returned product complaints; perform initial investigation and root-cause testing; and enter complete, accurate information into the GCMS complaint database.
• Ensure product traceability for all products received and analyzed.
• Partner with cross-functional groups (e.g., R&D and Manufacturing) to obtain information needed to complete investigations.
• Assist in maintaining and updating returned product test procedures.
• Identify opportunities and recommend improvements to complaint-handling processes and procedures.
• Maintain lab cleanliness and operate in compliance with corporate procedures and standards.

Education/Experience:

• HS diploma/GED is required.
• 1+ year of related experience.
• Proficient in Microsoft Word, Excel, and Outlook
• Solid technical writing skills

Preferred:

• Experience working in a regulated quality environment (e.g., complaint handling, investigations, and documentation).
• Experience using complaint management system (e.g. GCMS Trackwise)
• Understanding of basic electrical principles