Recruiter: Spencer Gregory Hale CCL Sr Quality Engineer About the role: The CCL Quality Engineer performs assessments of Boston Scientific Chemical Characterization Testing laboratory, suppliers, and quality research activities to determine compliance with the established internal/external requirements and to evaluate quality system effectiveness. Monitors testing activities and conducts internal and external quality audits to assure that applicable BSC Preclinical research activities comply with ISO 17025, ISO 10993, other applicable regulatory requirements and BSC policies and procedures. Supports Inspection Readiness, Preclinical Corrective and Preventative Action (CAPA) and acquisition integration. Your responsibilities include: Supports the preclinical function and influences them toward a state of inspection readiness at all times. Conducts internal and external quality audits of systems, preclinical testing laboratories, procedures, and controls employed in the conduct of preclinical activities conducted under ISO 17025, ISO 10993 and validated methods as applicable. Plans, schedules, and conducts vendor assessments. Communicates with global preclinical teams and Strategic Sourcing regarding new preclinical vendor requests, current preclinical vendor needs, and future needs related to ISO 17025 and 10993 testing activities. Evaluates the adequacy and compliance of systems, operations, and practices against regulations and company documentation through quality monitoring activities. Assesses the accuracy, validity, and quality of the chemical characterization data. Communicates final results of quality reviews and assessments to responsible management during formal management debriefs or other methods as applicable. Writes reports of quality reviews and results, obtains approval and publishes results to responsible management as applicable. Oversees follow-up of corrections and/or corrective actions and closure, including escalating overdue items as necessary. Supports or leads quality projects or initiatives as assigned. Supports and/or facilitates tracking of assessments and responses, review of documents and archival of records. Contributes to the development of quality procedures and processes. Assists in preparation of Testing Laboratories for FDA or other regulatory agency inspections. Keeps abreast of and interprets current worldwide regulatory requirements; advises management on the possible ramifications of regulatory changes. Support to the Preclinical organization in meeting BSC Quality system requirements. Supports the CAPA process, working cooperatively with NCEP/CAPA owners. Supports the gathering and reporting of various performance metrics for quarterly BU Management Review meetings. What we're looking for in you: Minimal requirements: * BS/BA in Chemistry or related life sciences discipline * Strong technical and quality knowledge of ISO/IEC 17025 * Strong verbal, written communication skills, both technical and conversational * 3-5 years Technical Experience, of which a minimum of 2 years in quality Preferred Qualifications: * 5+ years working in the medical device industry or other similarly regulated industry (e.g. pharmaceuticals, biologics, pre-clinical) * Strong technical and quality knowledge of ISO 10993-18 Requisition ID:579090 Among other requirements, Boston Scientific maintains specificprohibited substancetest requirements for safety-sensitive positions. This role is deemed safety-sensitive and, as such, candidates will be subject to a prohibited substance test as a requirement. The goal of the prohibited substance testing is to increase workplace safety in compliance with the applicable law. Boston Scientific is an Equal Opportunity Employer Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Disability, Veteran