Additional Location(s):US-CA-Valencia; Canada-ON-Mississauga; Ireland-Clonmel; Ireland-Cork; Ireland-Galway; Netherlands-Kerkrade; US-IN-Spencer; US-MA-Marlborough; US-MA-Quincy

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 Principal Quality Systems Compliance Engineer will be part of our growing Global Capital Equipment Quality Assurance team supporting BSC's high growth Medical Electrical Equipment [commonly referred to as Capital Equipment (CE)] portfolio. The individual will work closely with CE responsible teams across the product lifecycle to ensure design of agile and compliant processes. The role will also be responsible for partnering with teams on CE acquisitions and integrations to ensure compliant integration into BSC processes. This role will be collaborating with divisional, global and local Regulatory and Quality Systems compliance teams to help BSC achieve its goals while meeting external expectations.

This role will allow the incumbent to be exposed to all divisions and regions within BSC; and develop a global perspective and network. The incumbent will have opportunities to understand and impact processes that directly influence BSC's customer experience and meet global quality systems compliance expectations.

This role can be located in multiple BSC locations: USA (Valencia, Arden Hills, Maple Grove, Spencer, Marlborough, Quincy), Mississauga, CAN; BSC Brazil; BSC Argentina; Ireland (Clonmel, Galway, Cork); Kerkrade, NL

Key responsibilities will include:

• Understand BSC's Quality System and key external regulations and laws (including but not limited to relevant CFR, MDR, ISO 13485)
• Understand the CE product lifecycle processes (design, risk management, configuration management, design transfer, manufacturing, distribution and service) and their connectivity
• Understand CE Post Market processes including but not limited to product feedback, customer experience, compliant reporting and complaint investigation.
• Develop an understanding of external Quality Systems and compliance related regulations.
• Develop an understanding of outside-in perspectives held by regulators and incorporate that perspective into internal decision making.
• Partner with CE Process SMEs to interpret laws, regulations, standards and guidance and drive improvements and/or clarifications in BSC Quality System
• Help organization make decisions regarding process design and improvements with an understanding of big picture CE product lifecycle processes
• Partner with team on matters of addressing activities in Service Lifecycle, Post market feedback.
• Partner with acquisitions integration team on matter of CE related integrations to provide advice on Quality Planning, integration strategy & alignment and any subsequent adjustments strategies.
• Support audits related to Capital Equipment
• Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues as related to position responsibilities.
• Contribute actively to relevant internal BSC global Communities of Practice
• Work across the globe with flexible working hours to support BSC teams across the globe.
• Support and lead improvement projects to sustain Best4 Quality Strategy, ensuring Best Culture, Best Agility, Best Performance and Best Compliance.

Required qualifications:

• Bachelor's degree
• Minimum of 6 years of related work experience
• Demonstrated skills in understanding and interpreting laws, regulations, standards and guidance

Preferred qualifications:

• Experience working for FDA or other notified bodies
• Medical Device Capital Equipment experience
• Demonstrated skills in connecting big picture and applying the knowledge to decision making
• Must be proactive and able to work independently with minimal supervision; strong collaboration skills are essential
• Working knowledge of Medical Device Quality system experience
• Strong verbal and written communication, project management, and organizational skills
• Ability to influence and indirectly lead including in challenging situations.
• Proficient in use of PowerPoint

Requisition ID:579137

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 * 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.