Quality Auditor and Compliance Specialist (onsite)

Glens Falls, New York
BD
Responsibilities

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 o ur 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 of Position with General Responsibilities:

Primary: To execute the Internal Quality Audit program as established by the Quality Systems Manager. This includes performing and reporting on the results of internal quality system audits. Develop reports summarizing overall results to identify trends, if any.

Secondary: Maintain awareness of current compliance trends and focus areas documented in audits conducted by external agencies (e.g. FDA, Notified Body) and the corporate compliance department. Communicate them to the Sr. Facility Compliance Auditor for inclusion in the internal audit program.

Primary Essential Job Functions:

• Conduct internal quality system audits under the guidance of the Sr. Facility Compliance Auditor.
• Perform data analysis and prepare reports to summarize internal audit data.
• Prepare summary of findings and present to upper management.
• Make recommendations for and assist in the development of appropriate corrective actions to prevent recurrence. Produce justifications.
• Follow-up on corrective actions to verify effectiveness.
• Maintain awareness of compliance trends and areas of inspectional focus documented in audits of sister Bard facilities and other pertinent medical device manufacturers
• Assist the Sr. Facility Compliance Auditor with New Hire Compliance Orientation as required.

Secondary Essential Job Functions:

• Document and maintain accurate manual and computerized records.
• Communicate effectively (orally and in writing) with co-workers, superiors, support teams, others within the organization, outside vendors and other Bard divisions.
• Actively apply Quality concepts to meet compliance needs. (i.e. GMP, OSHA, Divisional and Corporate guidelines).
• Assist with Regulatory body inspections and/or requests
• Perform other related duties as assigned.

Basic Qualifications:

• Must have a working understanding of Quality Systems in a regulated industry.
• Excellent communication skills
• Technically Competent
• Ethical Behavior
• Computer skills (MS Excel, Word, Power Point)
• Able to call people to standards while creating and maintaining respectful relationships.
• Able to meet deadlines.
• Demonstrated abilities in planning, scheduling and managing data.
• Strong written communication and presentation skills.
• Demonstrated track record of thorough and accurate workmanship.
• Aptitude for, or demonstrated ability to, lead others.

Additional Desirable Qualifications:

ASQ Certified Quality Auditor or Certified Quality Engineer desired.

3-5 years auditing / quality system experience in a regulated industry, preferred.

Education and/or Experience:

• Bachelor’s degree in engineering or related degree, plus 1-2 years related experience (Medical Device preferably)
• Associated degree in engineering or related degree, plus 3-5 years related experience.

?Work Environment:

• Monday – Friday 8am-5pm
• Applicants must be authorized to work for ANY employer in the US. We are unable to sponsor or take over sponsorship of employment visa at this time.
• Some minor physical inconvenience or discomfort occasionally present in the work situation (moderate noise, disagreeable odors, etc.) and occasional exposure to situations that could result in a health hazard requiring some precaution.

Physical Demands:

Occasionally requires light physical effort as in periods of prolonged standing, sitting at machines or work tables or bending, stooping or reaching and/or lifting of object from desk to chair weighing 30 lbs, above shoulder weighing 30 lbs, push/pull 64 lbs, chair to floor 50 lbs., carry 50 lbs (2 hands); 25 lbs. one hand. May require some exposure to chemicals used in manufacturing processes. Training Requirements:

On-the-Job, SOPs required for position and GMP.

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

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 NY – Glens Falls

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