Job Description
Principal Quality Systems Specialist
Support the Europe, Middle East and Africa (EMEA) region in maintaining a robust Quality Management System, ensuring compliance with regulations and standards.
The successful candidate will provide Quality Systems support, independently process and assess Quality Systems, and communicate technical and compliance-related information to ensure the intended audience understands the potential impact.
Key Responsibilities:
- Implement, maintain, and improve the EMEA Quality Management System.
- Work with Quality management, department personnel, and other areas on process reviews and implementation of requirements in compliance programs.
- Plan and conduct scheduled internal audits to assess compliance with FDA, ISO, MDR, and internal requirements.
- Assess potential new suppliers for technical, quality, and manufacturing capabilities.
- Support and prepare for site-level internal audits and act as Subject Matter Expert (SME) in audits.
- Drive continuous improvements in the internal audit and customer feedback processes within the EMEA region.
- Act as a coach/mentor to aid development of junior staff members.
- Proactively investigate, identify, and implement best-in-class Quality Systems practices and implement/manage improvement projects within the organization.
- Collaborate with cross-functional colleagues regarding the impacts of enhancements and process changes.
- Execute the testing and training development for future rollouts of business applications.
- Drive awareness and compliance with applicable standard operating procedures/work instructions/standards and regulations.
Requirements:
- 5+ years of relevant experience in the Medical Device, Pharma, or Food environment.
- Green Belt certified with process management experience.
- Preferably has Auditing (Lead Auditor), Supplier Assessment, and Quality Systems experience.
- Familiar with quality tools and problem-solving techniques.
- Team player with strong work ethic and positive mentality.
- Good social and communication skills.
- Strong analytical skills, self-starter, and eager to improve.
About Boston Scientific:
As a leader in medical science for over 40 years, we are committed to solving the challenges that matter most – united by a deep caring for human life. Our mission to advance science for life is about transforming lives through innovative medical solutions that improve patient lives, create value for our customers, and support our employees and the communities in which we operate.