דרושים Principal Quality Systems Engineer ב-Boston Scientific ב-United States, Roswell

About the role:
We are seeking a strategic and experiencedto join our Quality team at the Johns Creek site. In this key role, you will serve as the subject matter expert (SME) on the Corrective and Preventive Action (CAPA) system, leading initiatives that enhance our quality systems and ensure compliance with global regulatory requirements. You’ll partner cross-functionally to promote a culture of continuous improvement, audit readiness, and quality accountability—driving Boston Scientific’s mission of transforming lives through innovative medical solutions.

Your responsibilities will include:

• Act as the SME for the CAPA system, managing and mentoring on CAPA and nonconformance processes.
• Lead preparation for and participation in external audits (e.g., FDA, ISO, MDSAP), including coaching staff on audit readiness best practices.
• Serve as a quality representative to increase awareness, visibility, and communication on quality initiatives across departments.
• Provide quality systems support to ensure compliance with Boston Scientific’s Quality System requirements and assess system effectiveness.
• Benchmark and implement best practices tailored to business needs while aligning with regulatory requirements and operational goals.
• Serve as a recognized leader in QSR, cGMP, ISO, and EU MDR standards; collaborate with the QA Director on critical quality decisions.
• Lead and support internal audits; identify opportunities for advancing the Quality Systems at the Johns Creek site.
• Monitor and report on quality metrics that drive continuous improvement and customer satisfaction.
• Champion cross-functional collaboration to align teams on quality and compliance goals.
• Cultivate a culture of accountability, customer focus, and ownership of quality responsibilities.
• Provide coaching and guidance to engineering and technical teams to strengthen quality capabilities.
• Apply structured problem-solving methodologies to address quality issues and communicate resolutions effectively.
• Track action items, report site metrics, and lead Management Review and CAPA Review Board meetings.
• Monitor progress against quality plans and escalate risks to leadership when necessary.
• Advise leadership on strategic quality system improvements that support long-term business objectives.

Required qualifications:

• Minimum of 10+ years experience in a Medical Device, Pharmaceutical or related field including a minimum of 5 years' experience in quality systems, quality engineering, or related function in the medical device industry.
• Demonstrated expertise in QSR, cGMP, ISO 13485, and EU MDR standards.
• Experience leading cross-functional teams and complex compliance projects.
• Ability to travel up to 10% for audits and cross-site initiatives.

Preferred Qualifications:

• Advanced degree (e.g., MS, MBA, MEM)
• Lead Auditor Certification ISO 13485:2016, ASQ CQA or CQM/OE.
• Proven ability to influence without authority and mentor others in quality disciplines.
• Prior experience with eQMS tools (e.g., TrackWise, Agile, MasterControl).
• Previous experience mentoring or leading others in quality system practices.
• Experience with quality metrics and data analysis to drive improvement.
• Prior experience with eQMS tools (e.g., SmartSolve, Windchill, MasterControl) and SAP.
• Previous experience mentoring or leading others in quality system practices.
  Experience with quality metrics and data analysis to drive improvement.

Maximum Salary: $ 188300

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.

Hybrid Roles:

Key responsibilities include:

• Leads quality team in sustaining activities to support commercial product monitoring on projects of major magnitude and scope. Key Quality voice of influence on projects.
• Leads quality team on functional deliverables and ensures technical excellence for product or technical development.
• Owns and drives deliverables related to Design Controls, Risk Management, Product Performance, Quality, and Compliance, key partner in all department goals and objectives. Including leading V&V activities and failure investigations.
• Develops and implements quality strategies; seeks innovative approaches to attaining quality goals, including continuous improvement and VIP.
• Hire, develop, and coach direct and indirect reports to provide technical leadership and support of multiple projects, and drive best practices throughout the organization.
• Foster a diverse workplace that enables all participants to contribute to their full potential in pursuit of organizational objectives.
• Determines appropriate staff levels and schedules. Works with key partners to understand priorities and plans resource allocation accordingly.
• Maintains and enhances cross-functional team relationships.
• Provides significant guidance regarding technical strategies and approaches; works cross-functionally in identifying and resolving technical issues.
• Monitor and ensure compliance with company policies and procedures (e.g. federal/country and regulatory requirements).
• Directly interfaces with internal and external audit activities.

What we're looking for in you:

Required Qualifications:

• Minimum of a Bachelor's degree
• Minimum of 7 years of related work experience or an equivalent combination of education and work experience
• Proven technical leadership and project management skills in medical device design, development, and commercialization
• Proven independent critical thinker, strong communication skills, strong presentation skills, and ability to build effective cross-functional relationships
• Ability to interface with customers to gather insight and get organizational buy-in on key design inputs
• Knowledge of Design Controls, Risk Management, NCEP/CAPA, Post-Market Surveillance, and FDA/ISO Medical Device Regulations
• Medical Device or regulated industry experience

Preferred qualifications:

• Bachelor in an engineering discipline
• Advanced degree in technical field or business.
• Experience leading technical teams.
• Experience with Design Controls, Risk Management, NCEP/CAPA, Post-Market Surveillance, and FDA/ISO Medical Device Regulations.
• Familiarity with BSC products and customer needs