Job Description Summary

Job Description

We are the makers of possible 

BD is one of the largest global medical technology companies in the world. Advancing the world of health™ is our Purpose, and it’s no small feat. It takes the imagination and passion of all of us—from design and engineering to the manufacturing and marketing of our billions of MedTech products per year—to look at the impossible and find transformative solutions that turn dreams into possibilities. 

We believe that the human element, across our global teams, is what allows us to continually evolve. Join us and discover an environment in which you’ll be supported to learn, grow and become your best self. Become a maker of possible with us.

Summary:

We are seeking a highly motivated and experienced Compliance Quality Specialist to join our team and help us deliver innovative medical devices to patients around the world. As a Compliance Quality Specialist, this position will play a crucial role in ensuring that our operations, processes, and products meet all regulatory and quality standards. This position involves monitoring compliance activities, managing audits, and implementing quality control measures to maintain and enhance our compliance framework. This role will also work closely with cross-functional teams to develop and implement project plans, identify and mitigate risks, and resolve any challenges that arise. The ideal candidate will have a proven track record of success in managing complex projects, as well as a strong understanding of project management principles and methodologies, with experience in audits, regulations, and compliance.

Key Responsibilities:

1. CAPA Management: Lead and oversee the Corrective and Preventive Action (CAPA) process, from identification and investigation to implementation and effectiveness monitoring. Ensure timely and effective resolution of quality issues.

2. Audit Coordination: Plan and manage internal / external audits and track observations. Collaborate with cross-functional teams to ensure adherence to regulatory requirements and internal policies. Identify areas of non-compliance and work with relevant departments to develop corrective action plans.

3. Quality Compliance Programs: Develop, implement, and maintain compliance and quality assurance programs. Streamline processes, eliminate redundancies, and ensure consistency in quality practices. Monitor and report on compliance metrics and performance indicators.

4. Regulatory Compliance: Stay up-to-date with relevant industry regulations and standards. Ensure that the QMS remains in compliance and lead efforts to adapt to regulatory changes. Prepare and present compliance reports to senior management

6. Continuous Improvement: Lead and participate in continuous improvement initiatives related to QMS processes, procedures, and quality standards. Collaborate with cross-functional teams to ensure continuous improvement in compliance and quality processes.

7. Training and Development: Provide training and mentorship to junior quality specialists, ensuring their growth and development within the organization.

Qualifications:

 - Bachelor's degree in a relevant field (e.g., Quality Management, Regulatory Affairs, Life Sciences), preferred

- 7 to 9 years of experience in quality management with a focus on CAPA, audits and regulatory compliance.

- Strong knowledge of quality management principles, methodologies, and relevant regulations (e.g., FDA, ISO, GMP).

- Proficiency in CAPA software and auditing tools. (e.g. Trackwise)

- Demonstrated experience in leading and participating in internal and external audits.

- Excellent analytical, problem-solving, and communication skills.

- Certification in Quality Management (e.g., Certified Quality Auditor) is a significant advantage.

Attributes:

 - Exceptional attention to detail and a commitment to data accuracy.

- Strong organizational and time management skills.

- Ability to lead and collaborate effectively in a cross-functional team environment.

- Analytical mindset with a passion for deriving insights from data.

- Demonstrated integrity in handling sensitive data and adherence to ethical standards.

For certain roles at BD, employment is contingent upon the Company’s receipt of sufficient proof that you are fully vacc