Additional Locations: (n/a)

Purpose and Passion • Comprehensive Benefits • Life-Work Integration • Community • Career Growth

At Boston Scientific, you will find a collaborative culture driven by a passion for innovation that keeps us connected on the most essential level. With determination, imagination and a deep caring for human life, we’re solving some of the most important healthcare industry challenges. Together, we’re one global team committed to making a difference in people’s lives around the world. This is a place where you can find a career with meaningful purpose—improving lives through your life’s work.

Quality Manager II

Quality Manager II who leads a team of Quality Engineers and Technicians in direct support of medical device manufacturing; responsible for driving continuous improvement in product quality and Quality Systems compliance, managing the control of non-conformances, and is a key partner to the Production and Manufacturing Engineering teams in achieving new product integration, cost, and customer delivery objectives.

At Boston Scientific, our products and technologies are used to diagnose or treat a wide range of medical conditions including heart, digestive, pulmonary, vascular, urological, pelvic health, and chronic pain conditions. We are a leading innovator of medical solutions that improve the health of patients around the world. We continue to innovate in key areas and are extending our innovations into new geographies and high-growth adjacency markets.

Purpose Statement

Develops and maintains quality policies and controls to ensure that product meets a high standard of customer satisfaction and conforms to global standards and regulatory requirements. Monitors field performance of product and customer feedback. Owns and manages quality discrepancies related to Manufacturing processes, Quality System, product, and customer complaints; and develops scope, disposition, and corrective actions for prevention of future discrepancies. May serve as liaison between the company and the various governmental agencies worldwide. Establishes and ensures compliance with good housekeeping practices, employee hygiene, and equipment sanitation. Partners closely with Production, Manufacturing Engineering, Design Assurance, R&D, and Global Supply Chain to drive continuous improvement in Quality, Cost, and Delivery on commercial products and to ensure new products are implemented with key process controls and product checks in place.

Key Responsibilities

  • Drives quality projects of major magnitude and scope.
  • Owns and drives deliverables related to Product Performance, Quality, and Compliance; key partner in all department goals and objectives.
  • Develops and implements quality strategies; seeks innovative approaches to attaining quality goals.
  • 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.
  • Develops department budget and monitors spending.
  • Determines appropriate staff levels and schedules. Works with key partners to understand priorities and plans resource allocation accordingly.
  • Maintains and enhances cross-functional team relationships.
  • Provides significant guidance regarding technical strategies and approaches; works cross-functionally in identifying and resolving technical issues.

Management Requirements

  • Lead a team of employees in the achievement of organizational goals. Guide, coach, direct, and develop direct reports, and drive best practices throughout the organization.
  • Foster a diverse workplace that enables all participants to contribute to their full potential in pursuit of organizational objectives.
  • Monitor and control the activities and budget of one or more functional areas, divisions, product groups, projects/programs, and/or operations.
  • Monitor and ensure compliance with company policies and procedures (e.g. federal/country and regulatory requirements).

Basic Qualifications:

  • Bachelor’s degree plus 7-9 years of related work experience or an equivalent combination of education and work experience
  • 5+ years of direct supervisory leadership experience with and people development
  • Technical background, 4-year engineering degree preferred with a passion for continuous improvement
  • Medical Device or regulated industry experience
  • Previous experience managing external audits with FDA and Medical Device Notified Bodies such as TUV, DEKRA, BSI

Preferred Qualifications:

  • Experience leading technical teams
  • Experience supporting a manufacturing environment
  • Advanced degree in a technical field or business

Quality System Requirements

  • In all actions, demonstrates a primary commitment to patient safety and product quality by maintaining compliance to the Quality Policy and all other documented quality processes and procedures.
  • Assures that appropriate resources (personnel, tools, etc.) are maintained in order to assure Quality System compliance and adherence to the BSC Quality Policy.
  • Establishes and promotes a work environment that supports the Quality Policy and Quality System.

About us

As a global medical technology leader for more than 35 years, our mission at Boston Scientific (NYSE: BSX) is to transform lives through innovative medical solutions that improve the health of patients. If you’re looking to truly make a difference to people both around the world and around the corner, there’s no better place to make it happen.

Requisition ID: 475918

Nearest Major Market: Alpharetta

Nearest Secondary Market: Atlanta

Job Segment: Housekeeping, Medical, Engineer, Medical Technology, Quality, Healthcare, Engineering