Quality Engineer

Responsibilities will include: Support laboratory functions to maintain compliance with applicable regulations

and standards, validated methods, and internal policies, procedures and work instructions, while promoting continuous inspection readiness. Collaborate with quality management and laboratory management on process improvement initiatives, quality trends and continuous improvement projects. Conduct internal and external quality assurance audits of systems, testing laboratories, procedures and controls used in testing activities under applicable regulations and standards. Plan, schedule and conduct vendor audits. Partner with global preclinical teams and Strategic Sourcing regarding new vendor requests and ongoing vendor needs. Evaluate the adequacy and compliance of systems, operations and practices through facility- and process-based audits and quality monitoring activities. Assess the accuracy, validity and overall quality of preclinical study data. Communicate final results of quality reviews and audits to management and technical staff. Write and publish audit and quality review reports, obtain appropriate approvals and distribute findings to responsible stakeholders. Oversee follow-up of corrections and corrective actions, escalated overdue items and support timely closure. Support or lead assigned quality projects and initiatives. Track audits and responses, support document review activities and maintain appropriate records. Contribute to the development and continuous improvement of quality procedures and processes. Assist laboratories in preparation for accrediting body, notified body, FDA or other regulatory inspections. Support the preclinical organization in meeting Boston Scientific Quality System requirements. Support the CAPA process in partnership with CAPA owners. Support compliance review meetings in accordance with site procedures.

Strong technical and quality knowledge of ISO/IEC 17025, ISO 13485 and/or 21 CFR 58 Strong verbal and written communication skills, both technical and conversational Minimum of 3 years' experience in a technical role

Minimum of 4--5 years' experience working in the medical device industry or other similarly regulated industry, such as pharmaceuticals, biologics or preclinical environments