Quality Systems Engineer III

Additional Location(s): US-MA-Marlborough; US-MN-Arden Hills; 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.

About This Role:

In support of Global Sourcing, the Quality Systems Engineer will focus on material (supplier) controls and serve as a Quality representative to improve awareness, visibility and communication on quality initiatives and objectives, and will support assigned functional, divisional, site and corporate quality goals and priorities.

Your Responsibilities will Include:

• Leading and participating in cross-functional projects teams and implementing project management best practices to effectively coordinate activities, communicate progress, collaborate on key deliverables and meet critical phase timelines

• Driving continuous improvement and globalization by gaining alignment across all divisions in compliance with BSC policies and regulatory standards

• Engaging and Influencing across the BSC Global Sourcing and Global Quality System organization to deliver long term strategic outcomes

• Conducting ongoing and thorough evaluations of material controls processes and scrutinizing documentation to maintain adherence to global BSC procedures, FDA regulations, ISO 13485, and medical device requirements

• Owning systemic CAPAs that are highly visible on a global scale

• Offering guidance to functional groups and teams in areas of process responsibility, including supplier audit/AVL, material qualification, procurement, supplier changes, and corrective actions

• Identifying and monitoring key material controls metrics and trends to verify the global process's proper implementation and effectiveness

• Engaging in and leading relevant BSC Communities of Practice to ensure that global processes consistently produce outputs that meet BSC standards and external regulatory requirements

• Supporting new business development initiatives, such as digital health technologies and acquisitions

Required Qualifications

• Bachelor's degree in any engineering or science discipline

• Minimum of 3 years of experience in a medical device manufacturing or similarly regulated environment

• Minimum of 3 years of experience in a Supplier Quality, Supplier Engineering, or Quality System organization

• Understanding of quality system requirements as stated within 21 CFR Part 820 and ISO 13485

• Ability to travel 15%

Preferred Qualifications

• Master's Degree

• Certified in Quality Management System Requirements (ISO 13485) and FDA Quality System Regulation (21 CFR Part 820)

• Ability to manage multiple projects and collaborate with cross-functional teams to achieve deliverables

• Strong problem solving, technical writing, and documentation skills

• Proficient in MS office and database/analytics

Requisition ID: 583658

Among other requirements, Boston Scientific maintains specific prohibited substance 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 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.

Nearest Major Market: Boston

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