Quality Systems Manager I

Boston Scientific Gruppe; Arden Hills (MN); Hybrid; USD 102,000 - 194,000; Full time

Job summary

Boston Scientific is seeking a Quality Systems Manager I in Arden Hills, MN to lead a team responsible for Internal Audit and CAPA. This hybrid role requires on-site presence three days a week and collaboration with a global network to standardize and improve quality processes.

The candidate will mentor staff, drive continuous improvement, and ensure documentation and training compliance across the organization. Strong leadership and cross-functional partnering are essential.

Qualifications

• Bachelor's degree with 5+ years of related experience in medical device quality (or Master’s with 0-2 years).
• Experience with Corrective and Preventive Actions (NCEP, CAPA) and Internal Audit processes.
• Demonstrated leadership ability.
• Conflict management and negotiation skills.

Responsibilities

• Site ownership of Internal Audit and CAPA processes.
• Establish and promote continuous improvement in quality system compliance.
• Ensure training documentation and compliance across staff.
• Lead a high-performing team and recruit when needed.
• Foster diversity and inclusion within the workplace.
• Communicate quality performance to senior leadership and lead improvement meetings.
• Develop and implement quality strategies and drive projects of moderate scope.
• Review NCEP, CAPA and Internal Audit documentation for accuracy.
• Assist in department budgeting and resource planning.
• Maintain cross-functional relationships and policy compliance.

Skills

Leadership

Conflict management

Negotiation

Interpersonal skills

Education

Bachelor's degree with 5+ years

Master's degree with 0-2 years

Job description

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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.

Quality Systems Manager I

About the Role

At Boston Scientific, the Quality Systems Manager I will be responsible for managing a staff of quality system professionals with primary responsibilities for the Internal Audit and CAPA processes at the Arden Hills site. This role will report to the Senior Quality Systems Manager and partner with cross-functional teams and a global network to execute, standardize, and improve these processes. Additional activities will include providing guidance and mentoring across site functions regarding quality system compliance.

At Boston Scientific, we value collaboration and synergy. This role follows a hybrid work model requiring employees to be on site in Arden Hills, MN 3 days a week.

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

Your Responsbilities Include:

• Site ownership of systems including Internal Audit and CAPA.
• Establish, support, and promote a work environment of continuous improvement that supports BSC’s Quality Policy, Quality System requirements and appropriate regulations.
• Ensure employees are trained to do their work and their training is documented.
• 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.
• Manages Quality System activities/initiatives and communicates performance to senior leadership. Lead quality meetings regarding quality and/or compliance improvement.
• Develop and implement quality strategies; seek innovative approaches to attaining quality goals.
• Drive quality projects of moderate scope.
• Review and approve NCEP, CAPA and Internal Audit documentation.
• Assist in development of department budget and monitor spending.
• 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.
• Serves as a Quality representative to improve awareness, visibility and communication on quality initiatives to support department, functional, site, divisional and/or corporate quality goals and priorities.

What We're Looking For:

Required Qualifications:

• Bachelors degree required with 5+ years of related work experience within medical device quality or related discipline or master’s degree with 0-2 years of experience
• Experience with Corrective and Preventive Actions (NCEP, CAPA) and Internal Audit processes
• Demonstrated leadership ability
• Conflict management and negotiation skills
• Excellent interpersonal skills

Preferred Qualifications:

• Subject Matter Expert level experience in BSC Quality Management System Processes and Sub-Processes and BSC systems.
• Compliance background in regulations and standards.

Requisition ID:634141

Minimum Salary:$102100

Maximum Salary: $194000

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.

Boston Scientific transforms lives through innovative medical technologies that improve the health of patients around the world. As a global medical technology leader for more than 45 years, we advance science for life byprovidinga broad range of high-performance solutions that address unmet patient needs and reduce the cost of healthcare. Our portfolio of devices and therapies helps physicians diagnose and treat complex cardiovascular, respiratory, digestive, oncological,neurologicaland urological diseases and conditions. Learn more at www.bostonscientific.com and follow us on LinkedIn .

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.

Nearest Major Market: Minneapolis
Job Segment: Internal Audit, CAPA, Quality Manager, Project Manager, Finance, Management, Quality, Technology