Quality Tech III - 1st Shift

Boston ScientificArden Hills, MN
19hOnsite

About The Position

The Urology Complaint Investigation Site (CIS) in Arden Hills is seeking a Quality Technician III to support product complaint investigations for urology devices. This role is responsible for performing detailed product analyses on returned devices, authoring clear and thorough investigation reports, and collaborating with internal and external partners to ensure investigations are completed accurately and on time. Quality Technician III may partner closely with engineers to enhance analysis methods, update and maintain work instructions, and participate in continuous improvement initiatives. This position requires the ability to work independently while following established procedures and quality system requirements. A successful candidate demonstrates a strong ability to take direction, manage priorities, and deliver high-quality results with minimal supervision. We are looking for a collaborative team player with a strong desire to learn new skills, take initiative, and contribute proactively to a quality-focused environment.

Requirements

  • 4 years of experience with a high school diploma/degree/equivalent, or an equivalent combination of education/work experience
  • Must work well in a team environment
  • Proficient with Microsoft office tools
  • Good oral and written communication skills

Nice To Haves

  • Knowledge about electrical testing
  • Previous experience within the medical device industry
  • Self-starter with the ability to identify improvement opportunities
  • Able to work independently under limited supervision as well as in a team environment
  • Experience with the Global Complaint Management System (GCMS)

Responsibilities

  • Serve as a subject matter resources for device analysis and quality investigation processes
  • Perform testing, gather data, and analyze results of returned devices to ensure compliance with quality standards
  • Documenting product investigation activities with precise, technical, quality writing
  • Communicate quality concerns effectively to stakeholders through clear, timely emails
  • Assists engineers by reviewing complaint data and identifying issues in returned devices
  • Identify and troubleshoot processes, device failures, and equipment issues
  • Evaluate analysis process and current coding to support continuous improvement initiatives, enhance device investigations, and provide informative data
  • Assists engineers with qualification and validation studies & reports by collecting, compiling, measuring, organizing and recording data, and by writing procedures. May keep lab notebook.
  • May identify non-conformances, support escalations, and conduct additional investigations
  • Assist with NCEP and CAPA activities
  • Working with cross-functional partners to complete different parts of investigations
  • Participating in various continuous improvement projects

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What This Job Offers

Job Type

Full-time

Career Level

Mid Level

Education Level

High school or GED

Number of Employees

5,001-10,000 employees

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