Boston Scientific Principal Quality Systems Engineer 

United States, Massachusetts, Marlborough 

9117821

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

Maximum Salary: $ 197000

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.