Quality Systems Engineer III

Boston Scientific Gruppe; Marlborough (MA); Hybrid; USD 82,000 - 156,000; Full time

Job summary

Boston Scientific is seeking a Quality Systems Engineer III to support global quality systems and acquisition integration within document and records control. The role emphasizes collaboration with IT and stakeholders to maintain compliance, improve processes, and ensure system effectiveness across the organization.

The candidate will drive governance-based process ownership, support audits, CAPA, and risk management, and mentor team members while contributing to the quality systems roadmap

Qualifications

• 3+ years of quality systems experience in a regulated industry.
• Working knowledge of ISO 13485, 21 CFR Part 820 and EU MDR.
• Experience partnering with cross-functional stakeholders to support quality system processes and digital tools.
• Open to learning digital product ownership or IT project experience.

Responsibilities

• Own global quality process and compliance activities within a governance framework.
• Support standardization and audit readiness across regulations and standards.
• Collaborate with IT to configure and enhance digital platforms for document and records control.
• Lead root cause investigations and CAPA activities as needed.
• Support global quality system projects, acquisitions, and process implementations.
• Deliver training and mentor team members on quality system processes and tools.

Skills

Quality systems experience

Cross-functional collaboration

Digital product ownership

IT project experience

Tools

Windchill/PLM

Job description

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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 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 processes, including ISO 13485, 21 CFR Part 820 and EU MDR.
• Demonstrated experience partnering with cross-functional stakeholders to support quality system processes and digital tools
• Previous experience or open to learning digital product ownership, quality systems application support and/or IT project experience

Preferred qualifications:

• Medical device industry experience preferred
• Prior document control and records management experience preferred
• Experience supporting audits, inspections and CAPA activities
• Experience implementing or working with Windchill or another PLM system

Requisition ID:635652

Minimum Salary:$82100

Maximum Salary: $156000

The anticipated compensation listed above and the value of core and optional employee benefits offered by Boston Scientific (BSC) – see www.bscbenefitsconnect.com— will vary based on actual location of the position and other pertinent factors considered in determining actual compensation for the role. Compensation will be commensurate with demonstrable level of experience and training, pertinent education including licensure and certifications, among other relevant business or organizational needs.

At BSC, it is not typical for an individual to be hired near the bottom or top of the anticipated salary range listed above.

Compensation for non-exempt (hourly), non-sales roles may 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 for exempt, non-sales roles may 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.

Boston Scientific Corporation has been and will continue to be an equal opportunity employer. To ensure full implementation of its equal employment policy, the Company will continue to take steps to assure that recruitment, hiring, assignment, promotion, compensation, and all other personnel decisions are made and administered without regard to race, religion, color, national origin, citizenship, sex, sexual orientation, gender identity, gender expression, veteran status, age, mental or physical disability, genetic information or any other protected class.

Among other requirements, Boston Scientific maintains specificprohibited substancetest 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.

Nearest Major Market:

Boston

Job Segment:

Systems Engineer, Compliance, Medical Device Engineer, Document Control, Quality Engineer, Engineering, Legal, Administrative