Job Description Summary

The Internal Auditor Specialist identifies and reports key quality issues and regulatory compliance trends for the site / Business Unit. Associate collaborates with departments to identify issues wherein there is minimal impact on day-to-day operations and then partners with those same departments to achieve timely resolution of quality and regulatory compliance deficiencies. The Auditor supports initiatives involving facilities, new products, regulatory inspections, and various technical needs; provides insight into and coordinates quality and regulatory compliance training and education; and provides assessment services by coordinating and managing the internal audit program of the Quality System, as necessary.

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. 

Essential / Key Job Responsibilities:

• Participates in regulatory compliance audits and inspections.

• Develops and maintains audit schedules for internal audit program.

• Leads or participates in regulatory compliance audits and inspections.

• Provide objective, independent assessment of site / business unit’s quality, regulatory compliance and business risk to management.

• Perform Quality System audits of facilities or suppliers as assigned.

• Assesses compliance risk and recommends corrective action.

• Organizes and analyzes data so that the appropriate action can be taken.

• Leads or participates in investigations.

• Issues, monitors and provides corrective action follow-up for Quality System audits.

• Introduces or revises Quality system element procedures to maintain or achieve compliance to new or revised regulatory requirements at the direction of Quality management.

• Participates in the development of solutions to Quality System problems and/or non-compliance.

• Develops and maintains process for management of regulatory compliance audits and inspections.

• Provides periodic presentations regarding audit trends, corrective actions, etc.

• Assist in developing implementation strategies in accordance with FDA, MDSAP and health authority regulations.

• Demonstrate expert auditing skills and knowledge.

• Ability to benchmark industry trends and apply results.

• Liaisons with Segment and Corporate on behalf of BDPI, as necessary.

• Other duties and projects, as assigned.

Requirements:

• Auditing credentials / certification. (e.g. ASQCQA, ISO13485, EUMDR)

• Advanced to superior understanding and working knowledge of regulations.

• Advanced computer skills and software applications, including experience with Microsoft Office tools (Outlook, Word, Excel, PowerPoint)

• Advanced to Superior organizational and administrative skills

• Prior Medical Device and or pharmaceutical industry experience.

Education:

• Bachelor’s Degree in a related area plus experience in a Quality System auditing capacity, preferably in medical devices.

Experience:

• 5 years relevant experience

Physical Demands:

• While performing the duties of this job, the employee is regularly required to stand, walk, sit and use hands to manipulate, handle or feel objects, tools, controls and office equipment. 

• The employee frequently is required to talk and hear.

• The employee is occasionally required to reach with hands and arms and stoop, kneel or crouch.

Work Environment:

• Hybrid, Remote and General office setting

For certain roles at BD, employment is contingent upon the Company’s receipt of sufficient proof that you are fully vaccinated against COVID-19. In some locations, testing for COVID-19 may be available and/or required. Consistent with BD’s Workplace Accommodations Policy, requests for accommodation will be considered pursuant to applicable law.

Why Join Us?

A career at BD means being part of a team that values your opinions and contributions and that encourages you to bring your authentic self to work. It’s also a place where we help each other be great, we do what’s right, we hold each other accountable, and learn and improve every day.

You will learn and work alongside inspirational leaders and colleagues who are equally passionate and committed to fostering an inclusive, growth-centered, and rewarding culture. You will have the opportunity to help shape the trajectory of BD while leaving a legacy at the same time. And through the organization’s investment in BD University, you will continually level up your tech skills and expertise.

To find purpose in the possibilities, we need people who can see the bigger picture, who understand the human story that underpins everything we do. We welcome people with the imagination and drive to help us reinvent the future of health. At BD, you’ll discover a culture in which you can learn, grow and thrive. And find satisfaction in doing your part to make the world a better place. 

To learn more about BD visit https://bd.com/careers

Becton, Dickinson and Company is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.

PDN

Primary Work Location

USA AZ - Tempe Headquarters

Additional Locations

Work Shift

Salary : $63,700 - $80,700