Manager I, Quality

Recruiter: Spencer Gregory Hale

Quality Manager I, Design Quality Assurance

About This Role:

This role will provide Design Assurance leadership for New Product Development and Sustaining for the Core Stone product portfolio and lead a team of skilled Engineers.  The role will be responsible for ensuring product quality and compliance through leading the application of Design Control and Risk Management. Develops, establishes, and maintains quality assurance programs, policies, processes, procedures and controls ensuring that performance and quality of products conform to establish standards and agency guidelines to ensure lasting customer satisfaction.

Reviews, analyzes, and reports on quality discrepancies related to assembly, process, and product

function systems and develops disposition and corrective actions for recurring discrepancies. Collaborates with cross-functional teams including Research & Development, Regulatory, Marketing and Manufacturing Engineering teams in achieving successful manufacturing site transfers, avoiding backorders, design changes, and other product sustainment projects.  

This role is specific to the Core Stone franchise within the Urology Division of Boston Scientific. Lead team of quality engineers in the completion of product technical documentation for EU MDR submission including interfacing with and answering questions from notified bodies.

This is a hybrid position based in Marlboro, MA with the expectation to be on-site 3 days a week. 

Your Responsibilities will Include:

• Lead the execution of Quality Deliverables through successful implementation of Design Controls such as Verification Strategies, Field Assessment Plan, Design Change, Labeling, Clinical Reporting, and Design & Usability Validation plans.
• Champions 100% compliance to Company Policy and SOP’s. Devise and support the implementation of effective quality assurance, process controls, statistical analyses, and metrics that assure products meet or exceed internal quality as well as statutory requirements.
• Lead the execution of the Risk Management deliverables within your teams to ensure compliance to ISO 14971 and demonstrates a primary commitment to patient safety.
• Provide quality and regulatory guidance to assure country specific compliance to the laws and regulations of the targeted market for distribution.
• Support internal and external regulatory audits
• Review and approve NCEP and CAPA documentation
• Establish, support, and promote a work environment of continuous improvement that supports BSC’s Quality Policy, Quality System requirements and appropriate regulations.
• 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.
• Manages Quality System activities/initiatives and communicates performance to senior leadership
• Provides guidance and training to staff, assists subordinates in attaining career goals, motivates individuals to achieve results, and recruits and maintains a high-quality staff.

Lead a team of employees in the achievement of organizational goals.  Coach, direct, and develop a high performing team

What We're Looking For In You:

Minimum Qualifications

• Bachelor’s degree with 6+ years of related work experience within medical device quality or related discipline
• Experience with NCEP, CAPA and Internal Audit processes
• In depth familiarity with the FDA, ISO, MDD, EU MDR and the medical device industry quality requirements associated with product development, design controls, and product risk management.

Preferred Qualifications

• Experience leading technical teams
• Excellent interpersonal skills
• Excellent written and verbal communication

Requisition ID: 562261