Principal Quality Systems Engineer

Additional Location(s): US-MN-Maple Grove; Costa Rica-Coyol; Costa Rica-Heredia; Ireland-Clonmel; Ireland-Cork; Ireland-Galway; US-IN-Spencer

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:

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.

 

Key Responsibilities:

• Support the sub-process stewards in development and maintenance of process metrics and/or methods, as required, for performance, continous 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 applicabe 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 appliable within the global processes

 

Required Qualifications:

• 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.).

 

Preferred Qualifications: 

• 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.)
• Excellent interpersonal skills, including strong presentation skills
• Demonstrated inclusive leadership skills
• Strong analytical skills

 

 

Requisition ID: 620912 

Minimum Salary: $ 99100 

Maximum Salary: $ 188300 

 

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. Compensat