**Job Description Summary**: The purpose of this position is to assist the Quality Assurance Management in maintaining compliance with Laws and Regulations of the countries we sell product to, as well as to comply to applicable Quality Standards, such as ISO 13485. This position is mainly responsible of coordinating the processes of Quality System Internal Audits Program and Corrective Actions and Preventive Actions (CAPA) System. is responsible for managing the activities related to Quality Compliance department. Helps employees in the use of tools and guidelines to perform their work activities related to the processes of Internal Audits and CAPAs. Additionally, the duties of the Compliance Lead are to be an objective resource for Engineering, Operations, Purchasing and Supplier Quality related to applicable laws and regulations. The position interacts with people of all levels and diverse job positions to assure that compliance activities are executed on time and correctly.
For more than 125 years, we've pursued our Purpose of advancing the world of health. We relentlessly commit to a promising future by developing innovative technologies, services and solutions, helping the healthcare community improve safety and increase efficiency. It takes the imagination and passion of all of us at BD, from the manufacturing to marketing of our products, to look at the impossible and find transformative solutions to turn dreams into possibilities - For people today, tomorrow and beyond. Become a maker of possible with us!
For more than 125 years, we've pursued our Purpose of advancing the world of health. We relentlessly commit to a promising future by developing innovative technologies, services and solutions, helping the healthcare community improve safety and increase efficiency. It takes the imagination and passion of all of us at BD, from the manufacturing to marketing of our products, to look at the impossible and find transformative solutions to turn dreams into possibilities - For people today, tomorrow and beyond. Become a maker of possible with us!
- Represents the Facility and Quality Department in a professional manner.
- Manages the Quality Compliance department and the assigned resources (personnel, budget and equipment)
- Ensures compliance of the internal Audits Program, to National and International Standards and Regulations, Corporate, Divisional and Facility Policies and Procedures.
- Trains employees on National and International Standards and Regulations, Corporate, Divisional and Facility Policies and Procedures related with Internal Audits and CAPAs.
- Assists in the implementation of Corporate, Divisional, and Plant policies and procedures related to quality auditing, audit management, corrective and preventive actions, and compliance to Quality System Regulation (GMP), and ISO 13485.
- Provides leadership to internal plant operating personnel with respect to compliance and audit to identify, investigate and resolve potential quality deficiencies or areas of improvement.
- Performs specification reviews, gap analysis, and "walk-through" in the manufacturing area and the overall quality system to assure that all compliance activities are met.
- Tracks and analyze trends of Quality Indicators.
- Participates in the reception and coordination of external audits.
- Controls and maintains internal and external audit files, as well as the audit databases, to ensure that all audits are documented, analyzed, summarized, reported, and distributed.
- Prepares reports of the status of all quality audits monthly, quarterly, or as needed audits.
- Creates, reviews and approves Quality System Documents associated to his/her area of responsibility.
- Provides mentoring to new personnel in the Internal Audits and /or CAPAs processes.
- Prepares plans and Internal Audits Programs of the plant and ensures that all audits are executed, corrected, completed, and closed on time according to the program.
- Ensures that all the corrective actions documented, as for Internal Audits as CAPAs are adequate according to the applicable Laws and Standards.
- Communicates effectively with the organization management levels.
- Maintains information and records of internal and external Audits, including reports, evidence and follow up. Coordinates the CAPAs monthly meeting (CAPA Board).- Bachelor's in science, in a technical discipline or other undergraduate degree with equivalent technical experience, or a minimum of 3 years of quality work experience in the area of auditing, compliance or quality supervision in a regulated industry preferably.
- American Society of Quality (ASQ) certification (CQE, CQA, CQM, etc.)
Minimum 4 years of experience with FDA regulated industry including three years on internal audit programs and/or corrective and preventive actions preferably.
- Language Skill: Advanced
**Primary Work Location**: MEX Nogales South - Parque Industrial El Cid
**Additional Locations**:
**Work Shift**