Description:
About the role:
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.
Your responsibilities will include:
Serve as a subject matter resource for device analysis and quality investigation processes
Perform testing, gather data, and analyze results of returned devices to ensure compliance with quality standards
Document product investigation activities with precise, technical, quality writing
Communicate quality concerns effectively to stakeholders through clear, timely emails
Assist engineers by reviewing complaint data and identifying issues in returned devices
Identify and troubleshoot processes, device failures, and equipment issues
Evaluate analysis processes 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. Participate in various continuous improvement projects
Maintain and calibrate lab equipment
Required qualifications:
2 years of experience with a 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
Preferred qualifications:
Knowledge of electrical testing and implantable pulse generators
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)
**Manufacturing or investigative background with electrical devices
**Experience with neurostimulators product is a plus