Principal Quality Systems Engineer

Additional Locations: US-MN-Maple Grove;
Costa Rica-Coyol;
Costa Rica-Heredia;
Ireland-Clonmel;
Ireland-Cork;
Ireland-Galway; US-IN-Spencer

The Principal Quality Systems Engineer supports the development and maintenance of Global quality assurance policies, procedures, processes, and controls ensuring that performance and quality of processes and systems conform to established standards and agency guidelines. Acts globally as a subject matter expert on BSC production and process control quality requirements, policy, and procedures. Serves as a global quality representative to improve awareness, visibility, and communication on quality initiatives to support global quality goals and priorities.

Collaborates with global quality management to recommend, design and implement procedural improvements. May mentor and train less experienced staff, as well as other cross‑functional stakeholders, in implementing quality processes and procedures as appropriate.

This role is hybrid and can be based out of any BSC production site – Arden Hills, Maple Grove, Spencer, Galway, Cork, Clonmel, Coyol, or Heredia.

• Support the sub‑process stewards in development and maintenance of process metrics and/or methods, as required, for performance, continuous improvement, and monitoring for the Process Acceptance and Control processes.
• Support continuous improvement through the Quality System Steward and Community of Practice model against strategic roadmap plans of activities.
• 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 Production and Process Control processes for potential impact to BSC and initiate projects, as needed, to ensure continued compliance.
• Support or oversee quality projects of major magnitude and scope. Provide input and oversight to overall quality project portfolio and project priorities.
• Support external audit front rooms and back rooms, training for SME’s, 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 as applicable within the global processes.

• Minimum of a Bachelor’s degree.
• Minimum of 7 years experience in relevant field(s) related to medical device quality systems and/or production and process control or equivalent.
• Understanding of regulations and standards applicable to the BSC Global Quality System and Process Validation and Production Control (ISO 13485, 21 CFR 820, EU MDR, etc.).

• Understanding of specific regulations and standards applicable to BSC Global Quality System and Process Validation and Production Control (ISO 14971, ISO 11607, 21 CFR 210/211, etc.).
• Experience with enterprise control systems (e.g., Siemens’ Manufacturing Execution System, Product Data Management‑Windchill, etc.).
• Demonstrated inclusive leadership skills.
• Strong analytical skills.

Requisition : 620912

Minimum Salary: $99,100

Maximum Salary: $188,300

The anticipated compensation listed above and the value of core and optional employee benefits offered by Boston Scientific (BSC) – see  – 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…