Sr Compliance Engineer

Job Description SummaryCompliance Engineer responsible for coordinating and participating in Third‑party audits such as ISO‑13485, FDA, and internal/external audits. Tracks internal/external audit action plans, implements continuous improvement initiatives based on current and forthcoming regulatory compliance requirements, and serves as subject‑matter expert for regulatory compliance and auditing issues.Funciones y ResponsabilidadesIdentify and implement continuous improvement initiatives based on current and forthcoming regulatory compliance requirements.Provide training, coaching, and guidance to the site and team members; assist with planning and conducting external audits.Conduct training and coaching on audit procedures, documentation of findings, and support auditees in developing audit action plans and evaluating effectiveness.Monitors the timely completion of corrective action plans and coordinates the reporting of compliance metrics to site manufacturing facilities management during management reviews.Functions as a subject matter expert for regulatory compliance and auditing issues.Trains 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.Control and maintain external audit files and audit databases to ensure documentation, analysis, reporting, and distribution of audit results.Performs gap analysis for new or revised regulatory requirements to ensure compliance activities are met.Prepare external audit schedule and ensure on‑time completion.Responsible for disseminating quality system regulations education/training to BD Reynosa site personnel on an annual basis.Assist in the implementation of Corporate, Global, Business Units, and Local policies and procedures related to quality auditing, audit management, and compliance to Quality System Regulation (GMP), ISO 13485, and applicable regulations.Prepare reports on the status of external quality audits monthly, quarterly, or as needed.Maintain close contact with counterparts at Bard Operations Center (BOC) plants to address compliance issues.Foster teamwork and full associate engagement.Participate in the development and implementation of procedures to meet regulatory requirements.Support the evaluation and implementation of actions to eliminate root causes of non‑conformities related to internal/external audits.Support plant functions and the implementation of corporate programs and projects.Ensure compliance with BD policies and procedures.Interact with other BD facilities.Perform other duties as assigned by the supervisor, aligned with strategic priorities and business needs.RequirementsEducation and ExperienceBachelor’s degree in Engineering, Physics, or Biological Sciences.Over 5 years of quality, compliance, and regulatory experience in the Medical Device Industry, Combination Products, or pharmaceutical experience preferred.Over 3 years managing compliance/audit programs and conducting audits in the medical device or drug industry preferably.Accredited Lead Auditor is a preference (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 SkillsExcellent oral and written communication skills.Effective project management, communication and organizational skills are essential.Demonstrated ability to direct and provide advice on the use of process excellence and system design methodologies and tools to investigate and determine root cause, assess compliance risk and establish comprehensive and effective action plans.Ability to work in matrix management and work collaboratively and cross‑functionally across business units.Ability to conduct training and present material to a wide range of audiences.Fluency in speaking English and Spanish.Primary Work LocationMEX ReynosaEmployment typeFull‑timeJob functionManagement and ManufacturingIndustriesManufacturingReferrals increase your chances of interviewing at BD Nogales Norte by 2x #J-18808-Ljbffr