Quality Technician II

Quality Technician II

The primary responsibility of this role is to investigate returned pacemakers and conduct analyses based on the reported complaint. The candidate will collaborate with a broader group of approximately 20 individuals, including an immediate team of about 10. Strong attention to detail is essential. The primary purpose of the position is to ensure Cardiac Rhythm Management return product complaints are processed, reported and trended timely and accurately. Working under close to moderate supervision, incumbent receives general instructions on routine work and detailed instructions on new assignments.

Key Responsibilities

• 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.
• Follow up with CMC to confirm reported coding is accurate and to obtain additional information when needed.
• Prepare and route complaints for approval after confirming all required analysis and investigation documentation is complete.
• 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.

Qualifications Required Qualifications

• HS diploma/GED is required.
• Associate degree (AA) in Electronics (or equivalent related experience).
• 1+ year of related experience.
• Proficient 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, investigations, and documentation).
• Experience using complaint management system (e.g. GCMS Trackwise)
• Understanding of basic electrical principles
• Proficiency using electrical test equipment (e.g., oscilloscopes, digital multimeter, power supply, spectrum analyzer, source meter)

Working Conditions:

• May on occasion be exposed to loud sounds and distracting noise levels, such as from office equipment.
• The ability to lift up to 30lbs
• Use of computers and technology

Here at Canon Recruiting, People are our priority, and we are committed to Include Diversity in every segment of who we are. It is only through our Diversity we are made a stronger organization, and increase our ability to provide top tier candidates that our clients have come to know Canon for. We have an inclusive environment all employees are celebrated for their unique differences. The different perspectives and experiences of our workforce give us the competitive advantage that is essential for success in an ever-changing market. By promoting inclusion with the same enthusiasm, we devote to quality and competency, and using the experience from a diverse assortment of backgrounds and experiences, Canon is able to improve the services and value we deliver to clients, employees, and customers. At Canon, Diversification and Inclusiveness are much more than a corporate ambition; they are a critical component in our daily corporate life.Canon Recruiting is committed to a diverse and inclusive workplace. Canon Recruiting is an equal opportunity employer and does not discriminate on the basis of race, national origin, gender, gender identity, sexual orientation, protected veteran status, disability, age, or other legally protected pay range for this position is listed above. Base pay information is based on market location. We will consider for employment qualified applicants with arrest and conviction records. Our range of benefits may include health care and 401(k) savings plans.