Job description summary
compliance engineer for coordinate and participate in third-party audits such as iso-*, fda, and internal/external audits.
tracking of internal/external audits action plans.
identification, implementation of continuous improvement initiatives based on current and forthcoming regulatory compliance requirements associated with regulatory compliance.
job description
funciones y responsabilidades
responsible for the identification and implementation of continuous improvement initiatives based on current and forthcoming regulatory compliance requirements.
provide training and guidance for the reynosa team members and site management, and assist with the planning of external audits.
conduct training and coaching of the reynosa team on how to conduct audits, document findings, support the auditee in developing audit action plans, evaluate effectiveness checks, and review completion of all planned actions.
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-*, fda, and internal/external audits.
controls and maintains external audit files and audit databases, ensuring audits are documented, analyzed, summarized, reported, and distributed.
performs gap analysis for new or revised regulatory requirements to ensure all compliance activities are met.
prepare external audit schedule and ensure on-time completion.
assists in the implementation of corporate, global, business-unit and local policies and procedures related to quality auditing, audit management, and compliance with quality system regulation (gmp), iso * 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.
requirements
education and experience
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 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 skills
excellent 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 collaborate cross-functionally as well as across business units.
ability to conduct training and present material to a wide range of audiences.
fluency in english and spanish.
primary work location: mex reynosa
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