Design Quality Assurance Manager

Additional Location(s):  N/A

Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - High Performance

At Boston Scientific, we’ll give you the opportunity to harness all that’s within you by working in teams of diverse and high-performing employees, tackling some of the most important health industry challenges. With access to the latest tools, information and training, we’ll help you in advancing your skills and career. Here, you’ll be supported in progressing – whatever your ambitions.           

About the role
Boston Scientific is recruiting for a Design Quality Assurance (DQA) Manager at our Arden Hills, MN location. This exciting role involves leading a team of skilled engineers within the Pulse Field Ablation franchise to ensure product quality and compliance by applying Design Control and Risk Management processes. This role will support two key areas for electrophysiology products: (1) new product development and (2) sustaining activities. The role is hybrid with the expectation to be on-site 4 days a week.
 
Your responsibilities will include:

• Lead and develop a team of Design Quality Assurance Engineers who support new product development and sustaining projects of significant magnitude and scope.
• Foster a diverse and inclusive workplace that enables all participants to contribute to their full potential in pursuit of organizational objectives.
• Own and drive deliverables related to Design Controls, Risk Management, Product Performance, Quality, and Compliance.
• Provide guidance regarding technical strategies and approaches; work cross-functionally in identifying and resolving technical issues.
• Maintain and enhance cross-functional team relationships with key partners in Research & Development, Process Development, Regulatory, Operations, the broader Quality organization, and others as required.
• Generate, review, and approve documentation in the Windchill document control system. 
• Apply sound systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality and project issues.
• Serve as a Quality representative to improve awareness, visibility, and communication on quality initiatives to support departmental, functional, site, divisional and corporate quality goals and priorities.

What we're looking for in you:
Required qualifications

• Bachelor’s degree and a minimum of 5 years of relevant work experience or an equivalent combination of education and work experience
• Experience with Design Controls and Risk Management activities
• Ability to travel domestically and internationally as requested
• 1+ years of direct or indirect supervisory experience 

Preferred qualifications:

• Advanced degree in technical field
• Experience leading technical teams
• Prior clinical experience
• Experience in the medical device industry
• Use and understanding of regional and international quality system requirements including ISO 13485, ISO 14971, 21 CFR 820
   

 

 

 

Requisition ID: 602374 

Minimum Salary: $ 99100 

Maximum Salary: $ 188300 

 

The anticipated compensation listed above and the value of core and optional employee benefits offered by Boston Scientific (BSC) – see www.bscbenefitsconnect.com--will vary based on actual location of the position and other pertinent factors considered in determining actual compensation for the role. Compensation will be commensurate with demonstrable level of experience and training, pertinent education including licensure and certifications, among other relevant business or organizational needs. At BSC, it is not typical for an individual to be hired near the bottom or top of the anticipated salary range listed above.

 

Compensation for non-exempt (hourly), non-sales roles may also include variable compensation from time to time (e.g., any overtime and shift differential) and annual bonus target (subject to plan eligibility and other requirements).

 

Compensation for exempt, non-sales roles may also include variable compensation, i.e., annual bonus target and long-term incentives (subject to plan eligibility and other requirements).

 

For MA positions: It is unlawful to require or administer a lie detector test for employment. Violators are subject to criminal penalties and civil liability.

 

As a leader in medical science for more than 40 years, we are 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