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Quality Manager I Job

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Date: Nov 3, 2020

Location: Arden Hills, MN, US, 55112

Company: Boston Scientific





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.







About This Role:

Develops, establishes and maintains quality assurance policies, processes, and controls to ensure that product meets a high standard of customer satisfaction, and conforms to global regulatory standards and requirements. Monitors field performance of product and customer feedback.  Owns and manages quality discrepancies related to process, product, and customer complaints; and develops scope, disposition, and corrective actions for prevention of future discrepancies.  Establishes and ensures compliance with good housekeeping practices, employee hygiene, and equipment sanitation.  Partners closely with Production, Manufacturing Engineering, R&D, and Process Development 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.



Your Responsibilities Will Include:

  • 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.
  • May direct and control the activities and budget of one or more functional areas.
  • Monitor and ensure compliance with company policies and procedures (e.g. federal/country and regulatory requirements).
  • Owns and drives deliverables related to Product Performance, Quality, and Compliance.
  • Develops, provides guidance, and implements quality strategies and approaches; key partner in developing and implementing all department and site strategies.
  • Monitors and drives department progress against goals and objectives.
  • Provides coaching, leadership, and training to staff, assists subordinates in attaining career goals, motivates individuals to achieve results, and recruits and maintains a high performing team.
  • Develops a department budget and monitors spending.
  • Assists in and/or 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.
  • Works cross-functionally in identifying and resolving technical issues.  Drives innovative solutions and technical development.
  • Facilitates and supports NPE, Integrations and Acquisitions into the BU.
  • Facilitates the monitoring of new products and their performance during early commercial release.
  • Creation and oversite of the new Investigation team and processes. This includes leading a team to support required volumes and complaints metrics, maintaining a staffing plan and coordination with divisional Complaints teams.



What We’re Looking For In You: 

Minimum Qualifications

  • Bachelor's degree plus 4-6 years of related work experience or an equivalent combination of education and work experience
  • 3+ years of direct supervisory experience with a passion for leadership
  • Technical background, 4-year engineering degree preferred with a passion for continuous improvement
  • Medical Device or regulated industry experience
  • Experience in the NCEP and CAPA process including department process management and documentation
  • Strong verbal, written communication skills, both technical and conversational
  • Decision making and negotiation skills, individually and within groups
  • Experience in managing multiple projects across multiple organizational disciplines

Preferred Qualifications:

  • Experience leading technical teams and supporting a manufacturing environment
  • Experience in Production Essentials to partner for build and repair processes and metrics
  • Advanced degrees or statistical acumen
  • Experience with Risk Assessment process and documentation
  • Change Management experience
  • Project Management experience from project inception through delivery and maintenance
  • Demonstrated success in the audit process and use of audit controls






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: 469424


Nearest Major Market: Minneapolis

Job Segment: Housekeeping, Medical, Engineer, CAPA, Healthcare, Quality, Engineering, Management