Quality Tech II - 1st Shift
About The Position
The Urology Complaint Investigation Site in Arden Hills is seeking a Quality Technician II to support product complaint investigations for urology devices. The role performs detailed analyses of returned devices, prepares clear and thorough investigation reports, and collaborates with internal and external partners to complete investigations accurately and on time. The technician may work closely with engineers to improve analysis methods, update and maintain work instructions, and take part in continuous improvement initiatives. The role requires independent work in accordance with established procedures and quality system requirements, along with the ability to take direction, manage priorities, and deliver high-quality results with minimal supervision. The successful candidate is collaborative, eager to learn, proactive, and comfortable taking initiative in a quality-focused environment. This role follows a hybrid work model, with employees required to work from the Arden Hills, Minnesota office at least three days per week. Relocation assistance and employment visa sponsorship are not available.
Requirements
- At least 2 years of experience with a high school diploma, equivalent experience, training, or apprenticeships.
- Ability to work well in a team environment.
- Proficiency with Microsoft Office tools, including 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 and ability to collect data accurately while following complex processes.
Nice To Haves
- Knowledge of electrical testing.
- Previous experience in the medical device industry.
- Self-starter who can identify improvement opportunities.
- Ability 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 resource for device analysis and quality investigation processes.
- Test returned devices, gather data, and analyze results to assess compliance with quality standards.
- Document product investigation activities with precise technical and quality writing.
- Communicate quality concerns to stakeholders through clear, timely emails.
- Assist engineers by reviewing complaint data and identifying issues in returned devices.
- Identify and troubleshoot process, device failure, and equipment issues.
- Evaluate analysis processes and current coding to support continuous improvement, enhance investigations, and provide informative data.
- Assist engineers with qualification and validation studies and reports by collecting, compiling, measuring, organizing, and recording data, and writing procedures.
- Identify non-conformances, support escalations, and conduct additional investigations as needed.
- Assist with NCEP and CAPA activities.
- Work with cross-functional partners to complete different parts of investigations.
- Participate in continuous improvement projects.
- Maintain and calibrate laboratory equipment.
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
Education Level
High school or GED
