Senior Quality Systems Engineer
Boston Scientific
- Arden Hills, MN
- Permanent
- Full-time
- Understand BSC’s Quality System and Quality Systems Management Process.
- Develop, maintain and trend Quality metrics supporting CE Service business.
- Own Quality metrics review process(es) related to CE.
- Support audits related to Capital Equipment.
- Manage process based CAPAs/VIPs to address nonconformances and improvements.
- Trend CAPAs and NCEPs in CE Service process.
- Provide mentoring for other owners of NCEP and CAPA related to CE Service.
- Monitors compliance with company policies and procedures (e.g. compliance with FDA, BSI, EEO regulations, etc.).
- Key participant in Capital Equipment communities, to actively collaborate with the company’s strategy of making Capital Equipment a competitive advantage for BSC.
- Partnering with Capital Equipment Service process stakeholders to ensure compliance to BSC Quality System requirements and external regulations for Capital Equipment.
- Partner with CE Process SMEs to interpret laws, regulations, standards and guidance and drive improvements and/or clarifications in BSC Quality System.
- Support and lead improvement projects to sustain Best4 Quality Strategy, ensuring Best Culture, Best Agility, Best Performance and Best Compliance.
- Requires strong engagement with distribution and commercial region teams to understand business requirements and help set up or improve existing Quality System processes to support the business.
- Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues as related to position responsibilities.
- Contribute actively to relevant internal BSC global Communities of Practice.
- Work across the globe with flexible working hours to support BSC teams across the globe.
- Bachelor's degree
- Minimum of 5 years of related work experience
- Demonstrated problem solving skills, preferably in the CAPA process
- Proficient in use of Excel & PowerPoint
- Ability to understand procedural requirements and evaluate documents to ensure compliance to all applicable regulations and requirements
- Strong verbal and written communication, project management, and organizational skills
- Ability to influence and indirectly lead including in challenging situations
- Data analytics skills
- Must be proactive and able to work independently with minimal supervision; strong collaboration skills are essential