Principal Quality Systems Engineer
$106,800–$202,900 year
Hybrid · Valencia, California, United States
Job Summary
Lead global Quality System integration programs for acquisitions within the medical device sphere, aligning acquired entities with Boston Scientific’s Global Quality Management System while maintaining regulatory compliance and business continuity. Drive end-to-end quality system transformation, including CAPA, audit readiness, document and records control, and training processes; mentor teams and partner across R&D, Operations, Regulatory Affairs, and Supply Chain to resolve quality gaps and achieve scalable, enterprise-wide improvements. Influence global quality strategy and standardized integration models across newly acquired businesses, ensuring regulatory alignment with FDA, ISO, MDR and corporate requirements.
Required Qualifications
- Bachelor’s degree in Engineering or a related technical field
- Significant experience in a regulated industry, preferably within the medical device industry
- Demonstrated experience with Quality Systems including CAPA, change control, design controls, supplier controls, audits, and post-market quality activities
- Strong working knowledge of global Quality System requirements, regulations and standards
- Proven track record of leading complex, cross-functional initiatives and driving results
- Strong written and verbal communication skills
- Experience applying quality methodologies and maintaining compliant quality systems
- Ability to interpret, implement and ensure adherence to procedural and regulatory requirements
- Strong project leadership skills with ownership of large-scale initiatives
- Demonstrated mentorship and technical leadership capabilities
- Ability to operate independently in ambiguous, fast-paced environments
- Ability to manage multiple priorities while driving execution and accountability
- Preferred: Experience with implantable neurostimulation devices
- Preferred: Proven ability to influence stakeholders and drive outcomes without direct authority
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