Quality Engineer II
Listed on 2026-08-10
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Business
Regulatory Compliance Specialist
Urology Complaint Investigation Site Role
Join the Urology Complaint Investigation Site (CIS) department responsible for monitoring, identifying, investigating, and escalating product performance signals for the Urology division supporting our Axonics products. This is an exciting opportunity within the Post Market organization, where we are committed to transforming customer experiences into actionable insights that improve the lives of patients around the world.
In this role, you will collaborate across divisions and functions with Design Assurance, Research and Development (R&D), Supplier Engineering and Manufacturing teams to ensure a comprehensive understanding of product performance and help improve patient outcomes. This position is based in Arden Hills, Minnesota.
Your responsibilities will include:
- Provide technical insight into capital equipment products by partnering with cross-functional teams and the internal complaints organization to improve product investigations and reduce complaint trends.
- Provide technical guidance to identify and resolve quality issues using engineering fundamentals, structured problem-solving methodologies and investigative tools while expanding team utilization of investigative equipment.
- Partner with cross-functional teams to develop and implement streamlined, sustainable Complaint Investigation Site processes that meet organizational and regulatory requirements.
- Champion continuous improvement initiatives by leading and supporting projects across local and global Post Market organizations.
- Foster an inclusive work environment that enables employees to contribute to their fullest potential while supporting organizational objectives.
- Demonstrate a strong commitment to patient safety and product quality by maintaining compliance with the Quality Policy and all documented quality processes and procedures.
Qualifications:
Required qualifications:
- Bachelor's degree in Engineering, Science or a related technical discipline.
- Minimum of 2 years' experience in an engineering, quality or related technical role.
Preferred qualifications:
- Strong verbal and written communication skills with the ability to communicate effectively with both technical and nontechnical audiences.
- Strong decision-making, collaboration and negotiation skills in both individual and team settings.
- Experience managing multiple projects across diverse functional organizations.
- Experience working in a regulated industry, preferably within the medical device industry.
- Experience supporting complaint investigations, product performance analysis, quality engineering or post-market surveillance activities.
Boston Scientific transforms lives through innovative medical technologies that improve the health of patients around the world. As a global medical technology leader for more than 45 years, we advance science for life by providing a broad range of high-performance solutions that address unmet patient needs and reduce the cost of healthcare. Our portfolio of devices and therapies helps physicians diagnose and treat complex cardiovascular, respiratory, digestive, oncological, neurological and urological diseases and conditions.
Boston Scientific Corporation has been and will continue to be an equal opportunity employer. To ensure full implementation of its equal employment policy, the Company will continue to take steps to assure that recruitment, hiring, assignment, promotion, compensation, and all other personnel decisions are made and administered without regard to race, religion, color, national origin, citizenship, sex, sexual orientation, gender identity, gender expression, veteran status, age, mental or physical disability, genetic information or any other protected class.
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