Quality System Manager

Recruiter: Spencer Gregory Hale     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

Experience supporting audits or regulatory inspections Proactive problem