Senior Quality Systems Engineer
Boston Scientific
- Arden Hills, MN
- Permanent
- Full-time
- 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
- 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
- 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