Quality Assurance Manager

3 weeks ago

Arden Hills, Minnesota, United States Boston Scientific Full time

Job Summary:

Boston Scientific is seeking a Quality Assurance Manager to lead a team of supervisors, engineers, and technicians in supporting Manufacturing, New Product Development, and Quality Systems. The ideal candidate will have a passion for leadership and experience in medical device or other regulated industries.

Key Responsibilities:

  • Direct projects to ensure the manufacture of high-quality products and facilitate compliance with regulatory requirements.
  • Partner with Production, Manufacturing, Engineering, R&D, and Process Development to drive continuous improvement in quality, cost, and delivery on commercial products.
  • Develops, establishes, and maintains quality assurance programs, policies, processes, procedures, and controls ensuring that performance and quality of products conform to established standards and agency guidelines.
  • Implements a staffing plan by identifying resource requirements, writing justifications for additional staff, obtaining approval for changes, and coordinating the selection process with Human Resources.
  • Develops direct reports by securing appropriate training, assigning progressively challenging tasks, applying progressive disciplinary action as appropriate, and conducting formal written and verbal performance reviews.
  • Monitors daily work operations and provides direction and guidance to experienced exempt employees or skilled nonexempt staff to achieve unit or project goals.
  • Contributes to the development and monitoring of area budgets through regular analysis of cost and spending.
  • Identifies, develops, and implements processes to improve department performance.
  • Interfaces with manufacturing, engineering, customer, vendor, and subcontractor representatives to determine responsibilities and solutions.
  • Provides manufacturing support by defining work assignments directed to address manufacturing process defects and implement process improvements.
  • Directs Quality staff to support new product development by defining projects focused on new products/process development based on coordination with management, project leaders, and design engineers.
  • Implements improvements to Quality Systems and tools by directing staff to gather data on existing quality tools, identify weaknesses, and research/select new tools based on findings.

Requirements:

  • Bachelor's degree
  • Minimum of 4 years of related work experience
  • Minimum of 2 years of direct supervisory experience with a passion for leadership
  • Experience in medical device or other regulated industry

Preferred Qualifications:

  • Previous supervisory experience strongly preferred
  • Technical degree in engineering strongly preferred
  • Previous experience leading technical teams in manufacturing environment strongly preferred
  • Experience in the NCEP/NCMR and CAPA including department process management and documentation
  • Demonstrated success in the audit process and use of audit controls
  • Project management experience from inception through delivery and maintenance
  • Experience with risk assessment process and documentation

About Boston Scientific:

Boston Scientific is a leader in medical science for more than 40 years, committed to solving the challenges that matter most - united by a deep caring for human life. Our mission to advance science for life is about transforming lives through innovative medical solutions that improve patient lives, create value for our customers, and support our employees and the communities in which we operate.

Equal Opportunity Employer:

Boston Scientific is an equal opportunity employer and welcomes applications from diverse candidates. We are committed to creating an inclusive workplace that reflects the diversity of our patients, customers, and communities. We prohibit discrimination based on race, religion, color, national origin, citizenship, sex, sexual orientation, gender identity, gender expression, veteran's status, age, mental or physical disability, genetic information, or any other protected class.

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