Job Description Summary

Job Description

Funciones y Responsabilidades

1. Responsible for the identification, implementation of continuous improvement initiatives based on current and forthcoming regulatory compliance requirements associated with Regulatory Compliance.
2. Provide training and guidance for the Reynosa team members and site management. Assists with the planning of external audits. 
3. Conducts training and coaching of the Reynosa team members on the how to conduct audits, documentation of findings, support the auditee in the development of audit action plans and evaluation of effectiveness checks as well as to review/evaluate adequate completion of all planned actions via supporting
documentation.
4. Monitors the timely completion of corrective action plans and coordinates the reporting of compliance metrics to site manufacturing facilities management during management reviews.
5. Functions as a subject matter expert for regulatory compliance and auditing issues.

6. Trains employees on National and International Standards and Regulations, Corporate, Global and Facility Policies and Procedures.
7. Coordinate and participate in Third-party audits such as ISO-13485, FDA, and internal/ external audits.
8. Controls and maintains external audit files, as well as the audit databases, to ensure that all audits are documented, analyzed, summarized, reported, and distributed.
9. Performs gap analysis for new or revised regulatory requirements to ensure that all compliance activities are met.
10. Prepare external audits schedule and ensure on time completion.
11. Responsible for disseminating quality system regulations education/ training to BD Reynosa site personnel on annual basis.
12. Assists 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), and ISO 13485, and applicable regulations.
13. Prepare reports on the status of external quality audits monthly, quarterly, or as needed audits.
14. Maintain close contact with counterparts at Bard Operations Center (BOC) plants to address compliance issues.
15. Foster teamwork and full associate engagement.
16. Participate in the development and implementation of procedures to meet regulatory requirements.
17. Support the evaluation and implementation of actions to eliminate root causes of non-conformities related to internal/external audits.
18. Support plant functions and the implementation of corporate programs and projects.
19. Ensure compliance with BD policies and procedures.
20. Responsible for disseminating quality system regulations education/ training to BD Reynosa site personnel on annual basis.
21. Interact with other BD facilities.
22. Perform other duties as assigned by the supervisor, aligned with strategic priorities and business needs.

Requirements:

Education and Experience

1. Bachelor’s degree in Engineering, Physics or Biological Sciences.

2. Over 5 years on quality, compliance and regulatory experience in the Medical Device Industry, Combination Products, Regulatory requirements and/or pharmaceutical experience preferred.

3. Over 3 years managing Compliance/Audit programs and conducting audits in the medical device or drug industry preferably.

4. Accredited Lead Auditor is a preference (ASQ CQA, RAB, BSI, etc.)

5. Extensive experience implementing, interpreting, and providing guidance on domestic and international regulations for medical devices, pharmaceuticals, and combination products.

Knowledge and Skills

1. Excellent oral and written communication skills.

2. Effective project management, communication and organizational skills are essential.

3. 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 actions plans.

4. Ability to work in matrix management and able to work collaboratively and cross-functionally as well as across business units.

5. Ability to conduct training and present material to a wide range of audiences.

6. Fluency in speaking English / Spanish

Required Skills

Optional Skills

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Primary Work Location

Additional Locations

Work Shift