Senior Quality Systems Manager

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 the role:
With a passion for leadership, the Sr. Quality Systems Manager will lead a team responsible for ensuring compliance to internal and external requirements, and for driving continuous improvement in product quality and the quality system. Develop and maintain quality policies and controls to ensure that products meet a high standard of customer satisfaction and conform to global standards and regulatory requirements. Partner closely with global peers and users to drive continuous improvement in the effectiveness and efficiency of the Quality System.  Also partner with Maple Grove Production, Manufacturing Engineering, R&D, Design Assurance, and Process Development to drive continuous improvement in Quality, Delivery, and Cost on commercial products, to support effective acquisition integrations and product transfers, and to ensure new products are implemented with key process controls and product checks in place. May serve as liaison between the company and governmental agencies worldwide.

This is a hybrid position based in Maple Grove, MN with the expectation to be on-site 2 to 3 days a week.

Your responsibilities will include:

• Drive quality projects of major magnitude and scope.
• Site ownership of systems including Internal and External audits, CAPA, Management Controls, Statistics, and Software Quality. 
• Own and drive deliverables related to quality systems, product quality, and compliance; key partner in all Maple Grove site goals and objectives.
• Lead a team of employees in the achievement of organizational goals; provide guidance and training to staff, assist them in attaining career goals, and recruit and maintain a high-performing team.
• Foster a diverse and inclusive workplace that enables all participants to contribute to their full potential in pursuit of organizational objectives.
• Provide guidance and mentoring across site functions regarding quality system compliance and technical strategies; work cross-functionally to identify and resolve technical issues.
• Develop and implement quality strategies; seek innovative approaches to attaining quality goals.
• Develop department budget and monitor spend.
• Determine appropriate staff levels and schedules; work with key partners to understand priorities and plan resource allocation accordingly.
• Maintain and enhance cross-functional team relationships.
• Monitor and ensure compliance with company policies and procedures (e.g., federal/country and regulatory requirements).

Required qualifications:

• Bachelor's degree and 7+ years of related work experience in CAPA, Audits, and Management Controls
• Experience in leading internal and external audits including FDA inspections
• Demonstrated expertise in regulatory requirements (FDA regulations and ISO 13485)
• 2+ years of direct supervisory experience 
• Medical Device experience

Preferred qualifications:

• Advanced degree in a technical field or business
• Passion for leadership and passion for continuous improvement

#LI-Hybrid

Requisition ID: 557973

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!

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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.