Sr Compliance Engineer

Sr Compliance Engineer – BD – Reynosa, Mexico Job Description Summary Coordinate and participate in Third‑party audits such as ISO 13485, FDA, and internal/external audits; track action plans; implement continuous improvement initiatives based on regulatory compliance requirements. Responsibilities Identify and implement continuous improvement initiatives based on current and forthcoming regulatory compliance requirements. Provide training, guidance, and coaching to Reynosa team members and site management on audit processes, documentation of findings, and development and evaluation of audit action plans. Monitor timely completion of corrective action plans and report compliance metrics to site manufacturing facilities management during management reviews. Serve as a subject‑matter expert for regulatory compliance and auditing issues. Train employees on national and international standards and regulations, corporate, global, and facility policies and procedures. Coordinate and participate in third‑party audits such as ISO 13485, FDA, and internal/external audits. Maintain external audit files and databases, ensuring audits are documented, analyzed, summarized, reported, and distributed. Perform gap analysis for new or revised regulatory requirements. Prepare external audit schedules and ensure timely completion. Disseminate quality system regulations education & training to BD Reynosa site personnel annually. Assist in implementing corporate, global, business unit, and local policies and procedures related to quality auditing, audit management, and compliance with GMP, ISO 13485, and applicable regulations. Prepare monthly or quarterly reports on the status of external quality audits. Maintain close contact with counterparts at Bard Operations Center (BOC) plants to address compliance issues. Foster teamwork and associate engagement. Assist in developing and implementing procedures to meet regulatory requirements. Support the evaluation and elimination of root causes of non‑conformities related to internal/external audits. Support plant functions and implementation of corporate programs and projects. Ensure compliance with BD policies and procedures. Interact with other BD facilities. Perform other duties as assigned in alignment with strategic priorities and business needs. Requirements Bachelor’s degree in Engineering, Physics, or Biological Sciences. Over 5 years of quality, compliance, and regulatory experience in the medical device industry, combination products, regulatory requirements, and/or pharmaceutical experience preferred. Over 3 years of managing compliance/audit programs and conducting audits in the medical device or drug industry preferred. Accredited Lead Auditor is preferred (ASQ CQA, RAB, BSI, etc.). Extensive experience implementing, interpreting, and providing guidance on domestic and international regulations for medical devices, pharmaceuticals, and combination products. Knowledge and Skills Excellent oral and written communication skills. Effective project management, communication, and organizational skills. Demonstrated ability to use process excellence and system design methodologies and tools to investigate and determine root cause, assess compliance risk, and establish comprehensive action plans. Ability to work in matrix management and collaborate cross‑functionally across business units. Ability to conduct training and present material to a wide range of audiences. Fluency in English and Spanish. Seniority Level Not Applicable Employment Type Full‑time Job Function Management and Manufacturing • Biotechnology Research • Medical Equipment Manufacturing • Research Services #J-18808-Ljbffr