Quality Systems Engineer III

Recruiter:
Spencer Gregory Hale Quality Systems Engineer III

About the role:

The Quality Systems Engineer III supports the Global Quality Systems and Acquisition Integration team within the Document and Records Control function. This role provides global process and digital system support, partnering with IT and cross-functional stakeholders to maintain compliance, support continuous improvement and ensure effective quality system performance. The position contributes to the development, maintenance and enhancement of quality system processes and tools that support compliant information lifecycle management across Boston Scientific.

Work model, sponsorship, and relocation:

At Boston Scientific, we value collaboration and synergy. This role follows a hybrid work model and requires the employee to work from a local Boston Scientific office at least three days per week. Eligible locations include the United States (Marlborough, MA; Arden Hills or Maple Grove, MN; or Dorado, PR), Israel (Yokneam or Yokneam Lumenis), Costa Rica (Global Hub), Ireland (Galway, Cork, or Clonmel), and Canada (Mississauga).Boston

Scientific will not offer sponsorship or take over sponsorship of an employment visa for this position at this time. Relocation assistance is not available for this position at this time.

Your responsibilities will include:

Global quality process and compliance ownership

Execute assigned process ownership responsibilities within a global governance framework while collaborating with global process stewards who provide compliance oversight.

Support standardization efforts and maintain audit readiness in accordance with applicable regulations and standards, including ISO 13485, 21 CFR Part 820 and EU MDR.Participate in process monitoring, documentation updates, regulatory implementation activities and issue resolution to maintain a permanent state of compliance.

Digital quality systems and IT partnership

Serve as a quality systems subject matter expert and business partner for digital platforms supporting document and records control processes.

Collaborate with IT and cross-functional stakeholders to support system configuration, enhancements, issue resolution and lifecycle management activities.

Partner with IT to translate business and regulatory requirements into technical solutions, validation activities and testing strategies.

Support root cause investigations, incident management and timely resolution of system-related issues to minimize business disruption.

Continuous improvement and operational excellence

Support continuous improvement initiatives using structured methodologies, including VIP, to drive efficiency, scalability and operational excellence.

Identify, analyze and resolve quality system issues using systematic problem-solving methodologies, considering common practice or procedures.

Drive process enhancements that strengthen quality culture and improve overall system effectiveness.

Quality events, CAPA and risk management

Serve as an owner or contributor for nonconformance, exception and CAPA activities.

Support root cause analysis, corrective and preventive action planning, implementation and effectiveness verification.

Contribute to risk management activities and systemic issue resolution efforts.

Project leadership and global collaboration

Support global quality system projects, including process implementations, business transfers and acquisition integrations.

Contribute to the global quality systems roadmap and support alignment with organizational commitments and priorities.

Participate actively in Communities of Practice activities to promote standardization and adoption of best practices.

Audit and regulatory support

Support external audits and regulatory inspections through preparation, execution, back-room support and follow-up activities.

Develop training materials, audit support documentation and related compliance resources.

Leadership, mentorship and training

Guide and support Quality Systems Engineers while contributing to team capability development.

Deliver training on quality system processes, digital tools and applicable regulatory requirements.

Support broader departmental and Quality Systems initiatives as business needs require.

What we're looking for in you:

Minimum requirements:

Bachelor's degree

Minimum 3 years' experience in quality systems within a regulated industry

Working knowledge of regulations and standards applicable to the Boston Scientific Global Quality System and Document and Records Control…