Job Description
Job DescriptionJob Title: Quality Technician II(Temp to hire)
Job Location: Arden Hills, MN- Onsite
Job Duration: 12 Months+ Possible extension
Shift: 1st Shift (6:00AM - 2:30PM)
Pay Range: $20 - $29/hr. w2
Position Overview:
- The primary responsibility of this role is to investigate returned pacemakers and conduct detailed analyses based on reported product complaints.
- The individual will collaborate with a broader group of approximately 20 team members, including an immediate team of about 10 colleagues.
- Strong attention to detail and the ability to work within a regulated quality environment are essential for success in this role.
Job Purpose:
- The purpose of this position is to ensure that Cardiac Rhythm Management (CRM) returned product complaints are processed, reported, and trended accurately and in a timely manner.
- Working under close to moderate supervision, the incumbent will receive general instructions for routine tasks and detailed guidance for new or complex assignments.
Key Responsibilities:
- Maintain compliance with applicable quality and regulatory requirements, including completing and documenting required training.
- Receive and verify returned product complaints.
- Perform initial investigations and root cause testing.
- Enter complete and accurate investigation data into the GCMS complaint database.
- Ensure full product traceability for all received and analyzed devices.
- Partner with cross functional teams (e.g., R&D and Manufacturing) to obtain necessary information for investigations.
- Follow up with CMC to confirm accurate complaint coding and gather additional information as needed.
- Prepare and route complaint reports for approval once all required documentation is complete.
- Assist in maintaining and updating returned product testing procedures.
- Identify opportunities for process improvements within complaint handling workflows.
- Maintain laboratory cleanliness and operate in compliance with corporate standards and procedures.
Qualifications:
Required Qualifications
- Associate degree (AA) in Electronics or equivalent relevant experience.
- Minimum of 1 year of related experience.
- Proficiency in Microsoft Word, Excel, and Outlook.
- Strong attention to detail.
- Solid technical writing skills.
Preferred Qualifications:
- Experience working in a regulated quality environment (e.g., complaint handling, product investigations, documentation).
- Experience using complaint management systems (e.g., GCMS, TrackWise).
- Understanding of basic electrical principles.
- Proficiency with electrical test equipment such as oscillo Products, digital multimeters, power supplies, spectrum analyzers, and source meters.
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