Principal Quality Systems Engineer & Records Controls Process Steward, Global Quality Systems

Principal Quality Systems Engineer & Records Controls Process Steward, Global Quality Systems

Work mode: Hybrid

Onsite Location(s): Marlborough, MA, US, 01752

Additional Location(s): US-MN-Maple Grove; US-CA-Valencia; US-MN-Arden Hills

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

Boston Scientific is seeking Principal Quality Systems Engineer & Records Control Quality Steward for its Global Quality Systems group. The purpose of this role is to provide strong leadership & stewardship of the Records Controls process & Community of Practice, as well as ownership of the digital systems transformation in the Document Management space.

The Principal Quality Systems Engineer will work as part of a broad global team within the Global Quality system and particularly with the team across the Document & Records Control process to identify synergies to progress Boston Scientific's goals & objectives, including supporting Acquisition Integration strategies. They will also mentor other Quality staff, as well as other cross-functional stakeholders on implementing Quality processes and procedures as appropriate.

Purpose Statement

The Principal Quality Systems Engineer will primarily lead the Corporate Quality System team in technical expertise as the sub-process Steward for Records Control within a Global Quality System. They will support the development and maintenance of quality assurance programs, policies, processes, procedures and controls ensuring that performance and quality of processes and systems conform to establish standards and agency guidelines. They will also champion all compliance activities within assigned area.

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.

At Boston Scientific, we value collaboration and synergy. This role follows a hybrid work model requiring employees to be in our local office at least three days per week.

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