Senior Quality System Engineer

Additional Location(s):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 the role:

As a Senior Quality System Engineer supporting external audits, the incumbent will be a key Quality representative responsible for driving Audit Excellence at the Maple Grove and Arbor Lakes sites. The incumbent will lead and coordinate efforts around audit readiness, preparation, execution, and closure activities. This includes interfacing with regulatory authorities (e.g., FDA, Notified Bodies, and global agencies), site quality teams, and global stakeholders. This role will also contribute to internal audit execution and support Boston Scientific's participation in the FDA's 'Case for Quality' program.

Work model, sponsorship, relocation:

At Boston Scientific, we value collaboration and synergy. This role follows a hybrid work model requiring employees to be in our local office Maple Grove, MN at least three days per week. Boston Scientific will not offer sponsorship or take over sponsorship of an employment visa for this position at this time. Relocation assistance is not available for this position at this time.

Your responsibilities will include:

• Lead Maple Grove external audit preparation, execution, and closure activities, including managing nonconformance and action response processes as needed.
• Lead and support audit readiness strategies for both Maple Grove and Arbor Lakes sites.
• Serve as the primary site representative on the External Audit Global Community of Practice.
• Collaborate with other Boston Scientific sites to provide cross-site external audit support as needed.
• Execute internal audits periodically for the Maple Grove and Arbor Lakes sites.
• Support continued participation in the Medical Device Discovery Appraisal Program as part of FDA's 'Case for Quality.'
• Promote a work environment that supports the Global Quality Policy, continuous improvement, and Boston Scientific's Core Values.
• Serve as an effective leader or team member in support of quality disciplines, decisions, and practices.
• Apply systematic problem-solving methodologies to identify, prioritize, communicate, and resolve quality issues.
• Partner with internal teams to provide guidance on Boston Scientific's Quality Management System and applicable regulations/standards.

Required qualifications:

• Minimum of Bachelor's degree and 5 years' experience in the medical device or pharmaceutical industry.
• Minimum of 2 years' experience in a Quality Systems role that includes internal or external audit support.
• In-depth knowledge of regulations/standards such as 21 CFR 820 and ISO 13485.
• Strong understanding of quality principles and interrelated job functions.
• Highly detail-oriented with strong analytical skills.
• Ability to make sound, risk-based decisions.

Preferred qualifications:

• Proven experience managing, coordinating, or supporting external audits of medical device quality systems.
• Minimum of 5 years' experience in audit support (internal, supplier, notified body, or regulatory audits).
• Excellent verbal and written communication, interpersonal, project management, and organizational skills.
• Ability to understand procedural documents and evaluate documents for compliance with applicable regulations and requirements.
• Ability to collaborate and communicate effectively across all levels of the organization.
• Ability to be proactive, work independently, and contribute to a highly visible team.

Requisition ID:622045

Minimum Salary:$85000

Maximum Salary: $161500

The anticipated compensation listed above and the value of core and optional employee benefits offered by Boston Scientific (BSC) - see www.bscbenefitsconnect.com-will vary based on actual location of the position and other pertinent factors considered in determining actual compensation for the role. Compensation will be commensurate with demonstrable level of experience and training, pertinent education including licensure and certifications, among other relevant business or organizational needs. At BSC, it is not typical for an individual to be hired near the bottom or top of the anticipated salary range listed above.

Compensation for non-exempt (hourly), non-sales roles may also include variable compensation from time to time (e.g., any overtime and shift differential) and annual bonus target (subject to plan eligibility and other requirements).

Compensation for exempt, non-sales roles may also include variable compensation, i.e., annual bonus target and long-term incentives (subject to plan eligibility and other requirements).

For MA positions: It is unlawful to require or administer a lie detector test for employment. Violators are subject to criminal penalties and civil liability.

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 Corporation has been and will continue to be an equal opportunity employer. To ensure full implementation of its equal employment policy, the Company will continue to take steps to assure that recruitment, hiring, assignment, promotion, compensation, and all other personnel decisions are made and administered without regard to race, religion, color, national origin, citizenship, sex, sexual orientation, gender identity, gender expression, veteran status, age, mental or physical disability, genetic information or any other protected class.

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.

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