Engineer II, Quality

Engineer II, Quality

Remote Eligible: Remote Global

Location: Marlborough, MA, US, 01752

Additional Location(s): US-MN-Arden Hills; Ireland-Galway; US-MN-Maple Grove

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.

Quality System Engineer II

About the role:
The Quality System Engineer II will serve as a Quality representative to improve awareness, visibility and communication on Global quality initiatives and objectives as well as support assigned departmental, functional, site, divisional and corporate quality goals, and priorities. He/she/they will support quality initiatives ensuring compliance to medical device regulations and BSC Quality System requirements, relating to Customer Related Service sub-process, with a continuous improvement mindset.

This position is 100% remote and is open to candidates located at any Boston Scientific site.

Your responsibilities include:

• Document and communicate internal and external compliance-related information, including changes in regulations, new guidelines, and guidance documents along with other information from regulatory authorities
• Apply effective, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues
• Assure the development and execution of streamlined business systems to effectively identify and resolve quality issues
• Document non-conformances, evaluate impact, and make recommendations for corrective actions
• Communicate non-conformances to owners, managers, directors, and upper management
• Support departmental, functional, divisional, and corporate quality goals and priorities
• Support quality disciplines, decisions, and practices
• Build quality into all aspects of work by maintaining compliance to all quality requirements
• Participate in CAPA and Continuous Improvement project teams as appropriate
• Perform other duties as necessary or required by the department or organization

Required Qualifications:

• Minimum of a Bachelor’s degree
• Minimum of 2 years’ experience in medical device manufacturing, quality, regulatory/compliance, or related field
• Working knowledge of quality system requirements as stated within 21 CFR Part 820 and ISO 13485
• Proficient with Microsoft Office applications (Outlook, Excel, PowerPoint)
• Willingness to travel up 10% internationally

Preferred Qualifications:

• Working knowledge of Windchill and SAP
• Experience with Quality Systems or Country/Distribution QA or experience working in a commercial or supply chain organization
• Ability to work independently and as a member of a team in a dynamic environment with experience writing and reviewing concise technical documents
• Experience communicating, facilitating, and presenting virtually to internal and external stakeholders on complex technical topics
• Strong project management and organizational skills with attention to detail and experience working in cross-functional teams and driving projects to completion

Requisition ID: 565632

Among other requirements, Boston Scientific maintains specific drug testing 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 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.