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Quality Engineer II

3 months ago

Arden Hills, Minnesota, United States Boston Scientific Full time

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 provideQuality Engineering support for Arden Hills Feedthrough and Coatings component area ensuring delivery of the highest quality result to the customer while supporting continuous improvement projects and quality initiatives.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. 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 assisting in identification of manufacturing process defects, identification of primary root causes, understanding corrective and preventative actions, and dispositioning non-conforming material. May be responsible for working with process owners to bound product and document release criteria.
  • Uses risk analysis tools, including but not limited to, hazard analyses, DFMEA, PFMEA, to evaluate and disposition product quality issues.
  • Perform process validation and verification activities, including test method validation, 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.
  • Leads process improvement efforts by identifying methods to capture quality metric data and by performing appropriate analysis methods to enhance sustaining product design and new product development.
  • Acts as 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.
  • Providesupport and mentorship to area Quality Technicians

What we're looking for in you:

Required Qualifications

  • Bachelor's degree in engineering or science-related field
  • Prior experience using non-conforming material review processes
  • Basic understanding of Test Method Validation methodologies
  • Minimum 2 years experience

Preferred Qualifications

  • Previous experience in regulated industry, preferably medical device industry
  • Familiar with the internal and external auditing process
  • Proficient in Microsoft Office; Word, Excel, and Outlook
  • Experience in writing, reviewing, and revising documentation
  • Highly motivated and a self-starter, capable of working independently and driving projects to completion
  • Capable of managing multiple projects, prioritizing, and meeting timelines
  • Strong organization skills and detailed-oriented
  • Must possess outstanding communication skills, both oral and written
  • Ability to communicate clearly and candidly the scientific concepts and project status
  • Effectively fostercollaborative relationships at all organization levels

Requisition ID:584734

Among other requirements, Boston Scientific maintains specific prohibited substancetesting requirements for safety-sensitive positions. This role is deemed safety-sensitive and, as such, candidates will be subject to a drug test as a pre-employment requirement. The goal of the drug testing is to increase workplace safety in compliance with the applicable law.

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 prohibited substance free workplace. Pursuant to Va. Code * , 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.



Boston Scientific is an Equal Opportunity Employer – Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Disability, Veteran