Quality Systems Manager I
About The Position
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.
Requirements
- 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
- Solid project management skills
- Excellent interpersonal skills
- Excellent written and verbal communication
Nice To Haves
- Subject Matter Expert level experience in BSC Quality Management System Processes and Sub-Processes and BSC systems.
- Compliance background in regulations and standards.
Responsibilities
- 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.
Benefits
- 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).
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
