Boston Scientific Principal Quality Systems Engineer & Records 

United States, Massachusetts, Marlborough 

289395401

Purpose Statement

The Principal Quality Systems Engineer will create a culture of compliance and facilitate adherence to the BSC Quality System and all appropriate regulations that BSC follows. They will ensure appropriate quality system processes are created, maintained, and followed in support of Corporate and Site quality objectives.

Your responsibilities will include:

• Quality System Stewardship for assigned area.

• Lead the development and ownership of the strategic roadmap, including digital transformation strategy.
• Lead identified activities through leadership of the Community of Practice.
• Implement training, technical tools and drive continuous improvement and efficiencies to support a preventive quality culture.
• Review and assess changes to standards and regulations applicable to the assigned area for potential impact to BSC and initiate projects, as needed, to ensure continued compliance.

• Lead or oversee quality projects of major magnitude and scope. Provide input and oversight to overall quality project portfolio and project priorities.
• Support external audits through leadership as an audit-facing SME, back rooms, training for SMEs, creation of storyboard material and site level support for Global procedures.
• Deliver process improvements through the VIP model with year over year savings against a multimillion-dollar yearly goal.
• Act as a CAPA owner for corrective actions necessary to improve the global processes.
• Champion departmental or cross-functional quality initiatives.

• Provide project direction, coaching, and mentoring for other team members, as required.
• Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.
• Assure the development and execution of streamlined business systems, which effectively identify and resolve quality issues.
• Advise management on potential improvements or enhancement to quality systems and processes in the company.

Required qualifications:

• Minimum of Bachelor’s degree in relevant field
• Minimum of 5 years of Quality Systems experience
• Regulated industry experience
• Understanding of regulations and standards applicable to the BSC Global Quality System and Document & Records Control processes (ISO 13485, 21 CFR 820, EU MDR, etc.).

Preferred qualifications:

• Advanced degree
• Medical device experience
• Document and/or Records Management
• Digital product ownership and/or IT project experience
• Strong analytical and communication skills
• Demonstrated inclusive leadership skills
• High degree of integrity, professionalism, and the ability to establish credibility internally and externally
• High sense of urgency and commitment to execution

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.