Principal Quality Systems Engineer

 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 Principal Quality Systems Engineer ensures the maintenance of quality assurance programs, policies, processes, procedures, and controls governing the HCP (Health Care Professional) Training programs for the WATCHMAN (WM) and ACURATE products. Additionally, this role will provide clinical quality assurance (CQA) leadership to ICTx and WM clinical teams as they execute pre-market and post-market studies. 
This is a global role that will partner with Medical Education and Clinical Trial teams to ensure the efficient and compliant implementation of BSC’s goals and objectives while maintaining adherence to medical device standards, regulations, and quality system requirements. This is a leadership role, that will be highly visible and influential within Clinical, Design Assurance, and Medical Education organizations.  

Your responsibilities will include:

• Serves as a quality systems expert, managing complex quality issues impacting the CQA and HCP training space. Leads internal partners through BSC’s quality system, while acting as a subject matter expert relative to the interpretation of regulations and their implementation.
• Partner with Clinical and Medical Education on quality escalations, NCEPs, CAPAs, and SCARs. Owns corrective and preventive actions as required. 
• Participates in the development, implementation, and maintenance of global quality systems. Works to identify ways to improve compliance with regulations and BSC policies and procedures for CQA and HCP training.
• Supports the preparation, coordination, and management of regulatory agency inspections of BSC offices and clinical sites.  Partners with clinical leadership to facilitate and maintain an audit-ready state for all WM and ICTx clinical studies. During an inspection, plays a lead role as facilitator and communicator.
• Proactively drive clinical and HCP training compliance, making data-driven decisions to facilitate process improvement and a proactive quality culture.
• Manage CQA portfolio activities and quality system deliverables for IC CQA, including but not limited to quarterly audit schedule updates, management of IC CQA surveillance activities, communication of quality signals to quality leads and clinical leadership, and coordination of clinical and clinical quality QMR deliverables for ICTx and WM. 
•  Quality System Requirements:
• In all actions, demonstrates a primary commitment to patient safety and product quality by maintaining compliance to the Quality Policy and all other documented quality processes and procedures.
• Assures that appropriate resources (personnel, tools, etc.) are maintained in order to assure Quality System compliance and adherence to the BSC Quality Policy.
• Establishes and promotes a work environment that supports the Quality Policy and Quality System.

Required Qualifications:

• Bachelor’s degree in Science, Health, or Engineering or a relevant field of expertise
• Minimum of 7 years of work experience in the medical device/pharma/ similar regulated industry
• Experience with quality systems/controlled processes 
• Strong presentation and communication skills
• Strong collaboration skills and critical thinking skills 

Preferred Qualifications:

• Working knowledge of US and International regulations and standards applicable to BSC 
• Experience with Medical Education and/or Clinical Quality Assurance 
• Experience with BSC IT systems (e.g. eCAPA, Windchill, APPROVE) desirable
• Experience working with cross functions such as Regulatory, Research and Development, Clinical, Medical, Sales Training and Quality

Requisition ID: 598837

The anticipated annualized base amount or range for this full time position will be $ to $, plus variable compensation governed by the Sales Incentive Compensation Plan (which includes certain annual non-discretionary incentives based on predetermined objectives) as well as the value of core and optional benefits offered at BSC, which can be reviewed at www.bscbenefitsconnect.com. Actual compensation will be commensurate with demonstrable level of experience and training, pertinent education including licensure and certifications, and other relevant business or organizational needs.

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 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 prohibited substance 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.

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