Senior Quality Systems Manager

Additional Location(s): 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:  Primarily responsible for managing the Corporate CAPA team and serve as Quality Management approver for the Corporate CAPA portfolio. This candidate will have oversight of the management of CAPA and NCEP to ensure compliance to internal procedures and global regulatory requirements.

Manage and partner with the Corporate CAPA Pillar (CAPA, NCEP and PIR) Stewards in development and maintenance of quality assurance programs, policies, processes, procedures and controls ensuring that performance and quality of processes and systems conform to establish standards and agency guidelines. Ensures appropriate quality system processes are maintained and followed in support of Corporate and Site quality objectives.

At Boston Scientific, we value collaboration and synergy. This role follows a hybrid work model requiring employees to be in our local office at least three days per week.
 

Relocation assistance is not available for this position at this time.
 

Boston Scientific will not offer sponsorship or take over sponsorship of an employment visa for this position at this time.

Your responsibilities will include:

• Leads and mentors the Corporate CAPA team
• Manages Corporate CAPA portfolio ensuring a high-quality standard and in line with applicable Management Review metrics.
• Acts as a CAPA owner/manager approver for corrective actions necessary to improve the global CAPA, NCEP and PIR processes as appliable.
• Provides guidance to eCAPA users globally related to CAPA and NCEP management and escalation. 
• Support Corporate and site level internal and external audit as needed. Provide guidance and expertise regarding audit strategies and approaches.
• Mentors Corporate CAPA, NCEP and PIR Stewards to create and champion improvement in the CAPA Pillar and all related SOP’s and business processes.
• Implements training, technical tools and drive continuous improvement and efficiencies to support a preventive quality culture.
• Ensures implementation of CAPA, NCEP and PIR processes and other functional excellence initiatives in Quality, including integration activities.
• Remains current on all quality systems regulations for all regulatory agencies related to the CAPA Pillar.

Required qualifications:

• Bachelor’s degree in relevant field
• Minimum of 5 years CAPA/NCEP, or equivalent, experience
• Proven leadership success through direct supervisory experience or experience leading cross-functional teams, implementing strategies, and achieving measurable results
• Understanding of regulations and standards applicable to the BSC Global Quality System and CAPA, NCEP and PIR processes (ISO 13485, 21 CFR 820, EU MDR, etc.)
• Experience with CAPA and CAPA concepts

Preferred qualifications:

• Strong verbal, written communication skills, both technical and conversational
• Provide guidance to BSC quality system teams globally on CAPA and NCP processes 
• Ability to work well under pressure, with multiple high priority deliverables
• Decision making and negotiation skills, individually and within groups
• Experience in managing multiple projects across multiple organizational disciplines
• Experience with major systems (e.g. eCAPA, Windchill, VIP) desirable
• Strong presentation skills and MS Office skills
• Strong analytical skills

Requisition ID: 604695 

Minimum Salary: $ 127900 

Maximum Salary: $ 243000 

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 identify, 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 specific prohibited substance test 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.