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Manager II, Product Complaint

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): 

Arden Hills, MN, US, 55112

Additional Location(s): US-MN-Maple Grove

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:

The Product Complaint Manager II will be responsible for planning, developing, and maintaining Post Market Surveillance compliance programs for the Cardiovascular Complaint Management Center supporting the Interventional Cardiology and Peripheral Intervention divisions. He/she/they will interface with key internal stakeholders including corporate, site, and business unit representatives. He/she/they will serve as the liaison between the company and various governmental agencies. He/she/they will work directly with operating entities to ensure Post Market Surveillance product complaint management processes are performed as required. He/she/they will work closely with CMC Managers to establish and ensure compliance with applicable global regulations (e.g. FDA 21 CFR Part 820.198, FDA 21 CFR Part 803, EU MDR, ISO 13485:2016), company and department policies and procedures.

 

Your responsibilities will include:

  • Recruit, coach and develop organizational talent.
  • Provide oversight to work done offsite and by 3rd party vendors to ensure adherence to standards.
  • Develop and implement department tools and methodologies pertaining to the product complaint management process to ensure compliance and to drive continuous improvement.
  • Develop and maintain Post Market Compliance programs, policies, and processes.
  • Develop and facilitate training and training support for the Post Market Surveillance organization.
  • Work cross-functionally to identify and resolve issues.
  • Determine appropriate staff levels, schedules and resources.
  • Act as an effective leader or team member in supporting quality disciplines, decisions, and practices.
  • Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.
  • Drive projects of major magnitude and scope.
  • Assure in the development and execution of streamlined business systems which effectively identify and resolve quality issues.
  • Provide solutions to a variety of technical and systematic problems of moderate to major scope and complexity.

 

Required Qualifications:

  • Minimum of a Bachelor’s Degree
  • Minimum of 10 years of related experience (complaint management, post market surveillance, quality systems)
  • Minimum of 3 years of management experience
  • Medical device experience required

 

Preferred Qualifications:

  • Proven leadership capabilities with a passion for developing others
  • Strong communication and problem solving skills
  • Experience managing remote teams

Requisition ID: 554525


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: Minneapolis

Job Segment: Medical Device, Compliance, QA, Quality Assurance, Manager, Healthcare, Legal, Technology, Quality, Management

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