Quality Technician II
$43,368–$43,368 year
HybridArden Hills, Minnesota, United States
Job Summary
Conduct detailed product analyses on returned urology devices, gather data, and troubleshoot failures to ensure compliance with quality standards. Author clear investigation reports, document activities with precise technical writing, and communicate quality concerns to stakeholders via email. Assist engineers by reviewing complaint data, identifying issues, collecting data for qualification studies, and writing procedures. Identify and resolve non-conformances, support escalations, and participate in continuous improvement initiatives to enhance device investigations. Maintain and calibrate lab equipment while adhering to established procedures and quality system requirements. This defined-term 12-month role requires a hybrid schedule with three days in the Arden Hills, MN office.
Required Qualifications
- 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
- Must be able to work independently while following established procedures and quality system requirements
- Must be able to take direction, manage priorities, and deliver high-quality results with minimal supervision
- Must be a collaborative team player
- Must have a strong desire to learn new skills, take initiative, and contribute proactively to a quality-focused environment
- Must be available to work in the Arden Hills, MN office at least three days per week
- Relocation assistance is not available for this position at this time
- Boston Scientific will not offer sponsorship or take over sponsorship of an employment VISA for this position at this time
- Must serve as a subject matter resources for device analysis and quality investigation processes
- Must perform testing, gather data, and analyze results of returned devices to ensure compliance with quality standards
- Must document product investigation activities with precise, technical, quality writing
- Must communicate quality concerns effectively to stakeholders through clear, timely emails
- Must assist engineers by reviewing complaint data and identifying issues in returned devices
- Must identify and troubleshoot processes, device failures, and equipment issues
- Must evaluate analysis process and current coding to support continuous improvement initiatives, enhance device investigations, and provide informative data
- Must assist engineers with qualification and validation studies & reports by collecting, compiling, measuring, organizing and recording data, and by writing procedures
- Must identify non-conformances, support escalations, and conduct additional investigations
- Must assist with NCEP and CAPA activities
- Must work with cross-functional partners to complete different parts of investigations
- Must participate in various continuous improvement projects
- Must maintain and calibrate lab equipment
- Must be subject to a prohibited substance test as a requirement
Desired Qualifications
- 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)
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