Quality Technician II

Boston ScientificArden Hills, MN
$43,368 - $73,736Hybrid

About The Position

The Urology Complaint Investigation Site (CIS) in Arden Hills is seeking a Quality Technician II 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. The Quality Technician II 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. This is a defined term position for 12 months.

Requirements

  • Minimum of 2 years with High School Diploma and/or equivalent experience, training, or apprenticeships
  • Must work well in a team environment
  • Proficient with Microsoft Office tools such as Outlook, Excel, Word, and PowerPoint
  • Proven experience using critical thinking and root cause analysis methodologies to investigate problems
  • Good oral and written communication skills
  • Ability to maintain a high level of accuracy in documentation, inspections, and data review
  • Strong attention to detail with the ability to collect data accurately while adhering to complex processes

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 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
  • Maintain and calibrate lab equipment

Benefits

  • Health insurance
  • Dental insurance
  • Vision insurance
  • Life insurance
  • Disability insurance
  • 401k
  • Employee stock purchase plan
  • Tuition reimbursement
  • Professional development
  • Wellness programs
  • Employee discount programs
  • Flexible scheduling
  • Paid holidays
  • Relocation assistance
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