Senior Quality Systems Engineer

Additional Location(s):  N/A

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 This Role: The Senior Quality Systems Engineer position reports directly to the Senior Manager, Quality Systems, Arden Hills, Minnesota.
 
The suitability, adequacy, and effectiveness of Boston Scientific’s Quality System as implemented throughout the Arden Hills, Minnesota site is audited frequently by various external regulatory compliance authorities (e.g., FDA, BSI, DEKRA, TUV-R, and other geography-specific agencies from around the world). The Sr Quality Systems engineer position leads and coordinates all efforts regarding external audit preparation, execution, and closure activities for each audit. The primary responsibilities of the role include interfacing directly with Arden Hills Quality System Process and Sub-Process owners, Subject Matter Experts, and Management and Global Quality Systems personnel, as needed, to ensure functions are clear regarding scope of each audit and expectations of readiness to support all audits involving those functions. Responsibilities include logistical preparation such as developing audit support staffing plans, communicating status of audit preparation, and leading preparation meetings with SMEs. This position also responds to Quality System information requests from worldwide Boston Scientific locations and may support additional activities such as Quality System integration and/or provide general support for other initiatives and projects. 
 
 

Your Responsibilities Will Include:

• Lead Arden Hills External Audit preparation, execution, and closure activities, including leading the nonconformance responses process if necessary
• Backroom Manager for Quality System external audits executed in Arden Hills
• Primary Arden Hills representative on the External Audit Global Community of Practice
• Lead the response to Quality System information requests from other BSC sites
• Lead information gathering and preparation activities for applicable global QS meetings and forums (e.g., audit readiness, signals review)
• Lead and/or support Quality System-related education initiatives
• Lead and/or support Quality System Sub-Process integration activities related to external audit readiness
• May educate functional areas on quality system requirements
• Work with Quality and other leaders to identify areas within the quality system in need of improvement and manage Corrective and Preventive Actions as appropriate
• Promote a work environment that supports the global Quality Policy, global Quality System, Continuous Improvement and Winning Culture at Arden Hills
• Act as an effective leader or team member in supporting quality disciplines, decisions, and practices
• Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues as related to the position responsibilities

 
 

Required Qualifications

• Bachelor’s degree and 5+ years relevant experience or Master’s degree with 3+ years relevant experience, preferably in medical device industry
• Comprehensive working knowledge, interpretation and application of all regulations and standards listed in the BSC Global Policy Quality System Management, including but not limited to:  21 CFR Part 820, ISO 13485, EU MDR 2017/745, AIMDD, MDD, MHLW Ordinance 169, MDR SOR/98-282, 21 CFR Part 211, ISO 14971, Therapeutic Goods Regulations 2002, Resolution RDC 16/2013, 21 CFR Part 4, as applicable to site
• Comprehensive working knowledge, interpretation and application of Medical Device Single Audit Program (MDSAP) program

 

Preferred Qualifications

• Experience managing, coordinating, or supporting external audits of medical device quality systems
• Excellent verbal / written communication, interpersonal, project management, and organizational skills
• Ability to understand procedural documents and evaluate documents to ensure compliance to all applicable regulations and requirements
• Ability to demonstrate equanimity, effectiveness, and leadership in challenging situations
• Ability to communicate with all levels of the organization
• Must be proactive, work independently, and be a contributing member of a highly visible team

Requisition ID: 580881

Among other requirements, Boston Scientific mai