Quality Engineer II

Work mode: Onsite

Onsite Location(s): Arden Hills, MN, US, 55112

Additional Location(s): N/A

Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - High Performance

At Boston Scientific, we'll give you the opportunity to harness all that's within you by working in teams of diverse and high-performing employees, tackling some of the most important health industry challenges. With access to the latest tools, information and training, we'll help you in advancing your skills and career. Here, you'll be supported in progressing whatever your ambitions.

About This Role:

The Quality Engineer II will provide Quality Engineering support for Arden Hills Manufacturing lines and New Products Introduction ensuring delivery of the highest quality result to the customer while supporting continuous improvement projects and quality initiatives. He/she/they will partner with manufacturing engineers for line support activities and with product development teams to ensure development of robust new products.

In a fast-paced and dynamic environment, the Quality Engineer II will be responsible for several manufacturing processes on the manufacturing line, working cross-functionally with manufacturing engineering and production teams to achieve business unit goals. He/she/they will be comfortable interfacing with downstream internal customers and providing quality leadership to a production team.

At Boston Scientific, we value collaboration and synergy. This role follows an work model requiring employees to be in our local office five 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.

Your Responsibilities Will Include:

• Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.
• Collaborate with technicians and manufacturing engineers in dispositioning non-conforming material, assisting in identification of manufacturing process defects, identification of primary root causes, and understanding corrective and preventative actions. May be responsible for working with process owners to bound product and document release criteria.
• Perform process validation and verification activities and generate/review related documentation
• Identifies possible sources of manufacturing defects and devises methods to reduce process variation to reduce/eliminate the cause of defects.
• Collects and analyzes process defect data for product/process improvement efforts (e.g. scrap, nonconforming product, customer complaints)
• Evaluates the adequacy and compliance of systems, operations, and practices against regulations and company documentation.
• Acts as an effective leader or team member in supporting quality disciplines, decisions, and practices.
• Participates in team decision making and displays team problem solving/communication skills.
• Proactively investigates, identifies, and implements best-in-class Quality Engineering practices.

Required Qualifications:

• Minimum of a bachelor's degree (STEM)
• Minimum of 2 years of relevant experience in the manufacturing of medical devices
• Knowledge of problem solving and statistical analysis techniques
• Knowledge of basic Quality Systems and good documentation practices

Preferred Qualifications:

• Certified Quality Engineer (ASQ CQE)
• Prior interactions with the following disciplines: manufacturing engineering, process development engineering, new product introduction, R&D and/or Design Assurance.
• Familiarity with product documentation, inspection and testing, and Manufacturing Execution preferred.