Engineer II, Quality

Remote Eligible: 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 the role:
The Quality Engineer II will provide Quality Engineering support for Arden Hills Sterile Pack, Final Pack, Sterilization area 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.
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.

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
• Minimum of 2 years of relevant experience

Preferred qualifications:

• Knowledge of basic Quality Systems and good documentation practices
• Prior interactions with the following disciplines: manufacturing engineering, post market complaints, CAPA, risk management, supplier quality, and process engineering
• Knowledge of problem solving and statistical analysis techniques
• Familiarity with product documentation, inspection and testing, and Manufacturing Execution
• Medical device experience preferred

Requisition ID: 562720

As a leader in medical science for more than 40 years, we are committed to solving the challenges that matter most – united by a deep caring for human life. Our mission to advance science for life is about transforming lives through innovative medical solutions that improve patient lives, create value for our customers, and support our employees and the communities in which we operate. Now more than ever, we have a responsibility to apply those values to everything we do – as a global business and as a global corporate citizen.

So, choosing a career with Boston Scientific (NYSE: BSX) isn’t just business, it’s personal. And if you’re a natural problem-solver with the imagination, determination, and spirit to make a meaningful difference to people worldwide, we encourage you to apply and look forward to connecting with you!

At Boston Scientific, we recognize that nurturing a diverse and inclusive workplace helps us be more innovative and it is important in our work of advancing science for life and improving patient health. That is why we stand for inclusion, equality, and opportunity for all. By embracing the richness of our unique backgrounds and perspectives, we create a better, more rewarding place for our employees to work and reflect the patients, customers, and communities we serve. Boston Scientific is proud to be an equal opportunity and affirmative action employer.

Boston Scientific maintains a drug-free workplace. Pursuant to Va. Code § 2.2-4312 (2000), Boston Scientific is providing notification that the unlawful manufacture, sale, distribution, dispensation, possession, or use of a controlled substance or marijuana is prohibited in the workplace and that violations will result in disciplinary action up to and including termination.

Please be advised that certain US based positions, including without limitation field sales and service positions that call on hospitals and/or health care centers, require acceptable proof of COVID-19 vaccination status. Candidates will be notified during the interview and selection process if the role(s) for which they have applied require proof of vaccination as a condition of employment. Boston Scientific continues to evaluate its policies and protocols regarding the COVID-19 vaccine and will comply with all applicable state and federal law and healthcare credentialing requirements. As employees of the Company, you will be expected to meet the ongoing requirements for your roles, including any new requirements, should the Company’s policies or protocols change with regard to COVID-19 vaccination.