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Quality Manager I - Design Assurance Job

Boston Scientific's hybrid workplace includes remote and onsite roles. By applying to this position, you will have the opportunity to discuss your preferred working location with your Talent Acquisition Specialist.

Remote Eligible:  Hybrid
Onsite Location(s): 

Marlborough, MA, US, 01752

Additional Location(s): US-MA-Quincy

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.



The Quality Manager I - Design Assurance provides leadership and guidance to the sustaining engineering team with a focus on identifying and meeting the quality goals for the Hydrogels portfolio within the the Urology and Pelvic Health Division (UroPh) for the Prostate Health franchise.  


Your responsibilities will include:

  • Manages and leads the quality engineering team by providing coaching, ongoing feedback, mentoring, training and ensuring employees receive development opportunities
  • Collaborates with division partners to ensure product development project plans and resources are properly developed and maintained
  • Coordinates the Design Assurance resource loading for the franchise’s Design Quality Assurance Sustaining and NPD activities
  • Identifies opportunities for improvement of the Product Development Process and initiates activities to support the improvement process
  • Participates in the development of the new products and processes, issues resolutions and design reviews participation
  • Acts as an adviser to subordinates and may become actively involved, as required, to meet schedules and resolve problems
  • Participates on teams, projects and assignments, facilitating or leading teams as necessary
  • Provides guidance to test methods, equipment acquisition, sample plan definition, and validation development
  • Participates in technical documentation of the international submissions
  • Assures product and process adherence to applicable medical device and electrical safety standards
  • Participates in internal and external audits
  • Presents data to upper management related to departmental metrics and key project milestones


What we are looking for in you:

Minimum Qualifications: 

  • Minimum of a bachelor's degree in chemistry, chemical engineering, or other related engineering/technical discipline
  • Minimum of 7 years of experience in quality and/or design assurance work experience in a regulated industry
  • Ability to travel up 15% (domestic and international)


Preferred Qualifications: 

  • Experience in the medical device industry
  • In depth familiarity with the FDA, ISO, MDD, EU MDR and the medical device industry quality requirements associated with product development, design controls, and product risk management
  • Supervisory and performance management/coaching experience



Requisition ID: 533461


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 medical solutions that improve patient lives, create value for our customers, and support our employees and the communities in which we operate. Now more than ever, we have a responsibility to apply those values to everything we do – as a global business and as a global corporate citizen.


So, choosing a career with Boston Scientific (NYSE: BSX) isn’t just business, it’s personal. And if you’re a natural problem-solver with the imagination, determination, and spirit to make a meaningful difference to people worldwide, we encourage you to apply and look forward to connecting with you!


At Boston Scientific, we recognize that nurturing a diverse and inclusive workplace helps us be more innovative and it is important in our work of advancing science for life and improving patient health. That is why we stand for inclusion, equality, and opportunity for all. By embracing the richness of our unique backgrounds and perspectives, we create a better, more rewarding place for our employees to work and reflect the patients, customers, and communities we serve. Boston Scientific is proud to be an equal opportunity and affirmative action employer.


Boston Scientific maintains a drug-free workplace. Pursuant to Va. Code § 2.2-4312 (2000), Boston Scientific is providing notification that the unlawful manufacture, sale, distribution, dispensation, possession, or use of a controlled substance or marijuana is prohibited in the workplace and that violations will result in disciplinary action up to and including termination.


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.



Nearest Major Market: Boston

Job Segment: Medical Device, Quality Assurance, Chemical Engineer, QA, Quality Manager, Healthcare, Technology, Engineering, Quality

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