Quality System Manager

Boston Scientific; Maple Grove (MN); Hybrid; USD 102,000 - 194,000; Full time

Benefits offered by this job

Hybrid work model

Job summary

Boston Scientific seeks a Quality Systems Manager to lead a team in Maple Grove, driving CAPA, QMR, and quality planning programs. You will partner with cross-functional teams and site leadership to improve quality governance and regulatory readiness.

The role requires 5+ years in quality engineering within medical devices or pharma, plus strong leadership and regulatory knowledge. Hybrid work model with in-office requirement applies; relocation sponsorship is not offered.

Qualifications

• Bachelor's degree required.
• Minimum of 5 years of relevant quality engineering experience in the medical device or pharmaceutical industry.
• Experience with Corrective and Preventive Actions (NCEP, CAPA) and QMR processes.
• Demonstrated leadership ability.
• Conflict management and negotiation skills.
• Strong interpersonal skills with the ability to communicate and collaborate effectively with cross-functional stakeholders across various levels.
• Knowledge of regulations/standards such as 21 CFR 820 and ISO 13485.

Responsibilities

• Lead a team of employees in achieving organizational goals and recruit a high-performing staff.
• Promote continuous improvement aligning with Quality Policy and regulatory requirements.
• Determine staffing levels and schedules with partners to plan resources.
• Act as SME for QMR, FSR, and Quality Planning sub-processes and provide guidance.
• Maintain and improve QMR and FSR tools and governance models for visibility and robust actions.
• Partner with CAPA SME to manage CAPA mentors."
• Review and approve NCEP, CAPA, QMR, FSR, and Quality Planning documentation.
• Develop and implement quality strategies and drive quality projects of moderate scope.
• Drive standardization and adoption of best practices across sites.
• Support audits and inspections with documentation and SME guidance.
• Provide quality system expertise for external audit readiness across site functions.

Skills

People leadership

CAPA/NCEP

QMR

Quality planning

Management reviews

Cross-functional collaboration

Regulatory knowledge

21 CFR 820

ISO 13485

Education

Bachelor's degree

Job description

Quality System Manager

About the role:

As the Quality Systems Manager supporting Management Control and CAPA processes, you will serve as a People Leader and a key Quality representative responsible for driving effectiveness, compliance, and continuous improvements across the Maple Grove site.

The Quality Systems Manager will be responsible for managing a staff of quality system professionals with primary responsibilities for Management Review Meetings, Quality Planning, and the CAPA Process. They will be the Technical Leader representing the QMR and Quality Planning sub-processes to internal and external stakeholders. This role will partner closely with the Maple Grove CAPA Technical Lead to execute/improve CAPA and Nonconformance activities. They will also partner with cross-functional teams, Site Leadership, as well as Regional and Global Quality Systems personnel to execute and drive improvements to Quality Management Review (QMR) and Feeder System Review meetings.

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 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 a team of employees in the achievement of organizational goals; provide guidance to staff, assist them in attaining career goals, and recruit and maintain a high-performing team.
• Establish, support, and promote a work environment of continuous improvement that supports BSC's Quality Policy, Core Values, Quality System requirements and appropriate regulations.
• Determine appropriate staff levels and schedules; work with key partners to understand priorities and plan resource allocation accordingly.
• Act as a Subject Matter Expert (SME) for Quality Management Review (QMR), Feeder System Review (FSR), and the Quality Planning sub-process, providing guidance on expectations, requirements, and best practices
• Partner with Site Leadership to maintain and improve QMR and FSR tools and governance models to provide appropriate visibility to signals and drive robust actions.
• Partner with the CAPA SME to provide guidance and manage resources of CAPA mentors
• Review and approve NCEP, CAPA, QMR, FSR, and Quality Planning documentation
• Develop and implement quality strategies; seek innovative approaches to attaining quality goals.
• Drive quality projects of moderate scope.
• Partner with cross-functional stakeholders to drive standardization and adoption of best practices across sites
• Drive continuous improvement and efficiencies to support a preventive quality culture
• Support internal and external audits and inspections by providing Management Control and Quality Planning related documentation and subject matter expertise
• Act as a Quality System resource for external audit readiness, providing guidance and mentoring across site functions regarding quality system compliance.
• Maintain and enhance cross-functional team relationships.

Qualifications:

Required qualifications:

• Bachelor's degree
• Minimum of 5 years of relevant quality engineering experience in the medical device or pharmaceutical industry
• Experience with Corrective and Preventive Actions (NCEP, CAPA) and QMR processes
• Demonstrated leadership ability
• Conflict management and negotiation skills
• Solid project management skills
• Strong interpersonal skills with the ability to communicate and collaborate effectively with cross-functional stakeholders across various levels in the organization
• Knowledge of regulations/standards such as 21 CFR 820 and ISO 13485

Preferred qualifications:

• Experience supporting audits or regulatory inspections
• Proactive problem solver with a continuous improvement mindset

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 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.

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.