Boston Scientific Design Quality Assurance Manager 

United States, Minnesota 

598393298

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
  

Maximum Salary: $ 188300

Compensation fornon-exempt (hourly), non-sales rolesmay 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 forexempt, non-sales rolesmay 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.

Please be advised that certain US based positions, including without limitation field sales and service positions that call on hospitals and/or health care centers, require acceptable proof of COVID-19 vaccination status. Candidates will be notified during the interview and selection process if the role(s) for which they have applied require proof of vaccination as a condition of employment. Boston Scientific continues to evaluate its policies and protocols regarding the COVID-19 vaccine and will comply with all applicable state and federal law and healthcare credentialing requirements. As employees of the Company, you will be expected to meet the ongoing requirements for your roles, including any new requirements, should the Company’s policies or protocols change with regard to COVID-19 vaccination.

Among other requirements, Boston Scientific maintains specific prohibited substance test requirements for safety-sensitive positions. This role is deemed safety-sensitive and, as such, candidates will be subject to a prohibited substance test as a requirement. The goal of the prohibited substance testing is to increase workplace safety in compliance with the applicable law.