Job Description Summary

How about becoming a maker of possible?

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!


Senior Quality Auditor

This position is responsible for the implementation and oversight of the BD Quality Audit program.
In this role, she/he is responsible for implementing quality and regulatory audits of BD facilities and providing training and guidance for quality auditors. She/he is responsible for planning of required annual audits and other audits as needed.
She/he monitors the timely completion of corrective action plans and coordinates the reporting of compliance metrics to business unit/region and manufacturing facilities.
She/he uses training, experience, and the information collected during audits to assist BD facilities with problem solving and continuous improvement projects as assigned.
She/he functions as a subject matter expert for quality and compliance issues.

Job Description

• Coordinate and conduct routine and focused quality system audits as assigned to assess compliance with domestic and international regulations and standards, and corporate, segment, unit, and local procedures and policies.
• Establishes audit teams through the use of qualified BD quality auditors and contracted auditors.
• Conducts Quality Audits to assure compliance with domestic and international medical device standards and regulations, local procedures, and corporate policies/procedures.
• Follows up with the auditee as required to compile information relating to the audits.
• Evaluates the adequacy of the provided evidence against the approved Audit Action Plan (AAP). In conjunction with management, develop plans to address inadequate AAP documentation when required.
• Maintains the audit system software database to record the status of all audits and associated actions. 
• Provides periodic reports to management based on the audit statuses and defined metrics.
• Maintains a high degree of personal professional development through a combination internal and external training and participation in professional associations as appropriate.
• This individual will be interacting with individuals at various levels of the organization across multiple sites/BUs and at Corporate during and when following up on audits. This position regularly interfaces with BU and Local leadership teams and compliance personnel to establish and implement schedules for corporate audits and gain acceptance/understanding of identified nonconformances without damaging the relationship with the site. 

Requeriments:

• B.S. Engineering, Chemistry, Biology or equivalent discipline, advanced degree is preferred.
• One of the below certifications or equivalent: (Required)
  • Certified Quality Auditor/ISO Lead Auditor Certified
  • Certified Quality Engineer
  • Certified Manager of Quality / Organizational Excellence
• Exemplar Global ISO 13485 Lead Auditor Certification or equivalent (Preferred)
  • Minimum 5 years of experience work experience in the Quality organization of a Medical Device and/or pharmaceutical company. Experience with warning letters and other regulatory actions preferred.
  • Minimum of 2+ years’ experience in with auditing compliance with domestic and international regulations for medical devices or pharmaceuticals.

“BD values equity in the workplace without discrimination for any disability, class, ethnicity, age, religion, gender identity or sexual orientation.”

Required Skills

Optional Skills

.

Primary Work Location

MEX Tijuana - Alaris El Florido

Additional Locations

Work Shift