Be part of something bigger at BD. Here, you’ll help us continually improve how we do things every day; to be more efficient, more effective and better serve our customers. You’ll do this within an exceptional team all striving to make sure that everything we do complies with regulations and standards, not just because it’s the right thing to do, but because our products impact people’s quality of life. Here, you’ll put your compliance experience, high expectations and attention to detail to the very best use: advancing the world of health™. At BD, you can make a true difference of one.
Job Description SummaryThe Associate Director of Quality reports to the Director Quality Systems, BD LifeScience (BDB) Business Unit. This position is responsible for the development and management of the systems and records relating to the BDB Quality Internal Audit (BQIA) program. Establishes and / or revises audit related BU procedures and policies including Auditor Qualification and Competency Program to ensure a consistent level of auditor competency across the organization. This position will also support the planning and implementation of Quality Systems strategy for BDB aligned with key driver goals including Quality Systems standardization/harmonization and IVDR Quality Systems compliance.
Be part of something bigger!
BD is one of the largest global medical technology companies in the world and is advancing the world of health by improving medical discovery, diagnostics and the delivery of care. We have over 65,000 employees and a presence in virtually every country around the world to address some of the most meaningful global health issues.
- Manages adequate and effective auditing of quality systems WW. Prioritizes internal audits on a timely basis to ensure compliance with appropriate standards and regulations including FDA, ISO 13485, ISO 9001, MDSAP, EU IVDR for the development, manufacture, release, and support of all products. Assists in development of corrective and preventive action when appropriate. Ensures effective reporting mechanisms are developed and followed.
- Supports BDX Corporate initiatives aimed at improving and standardizing the Internal Audit processes. Ensures programs are led, supervised, and delivered according to schedule
- Coordinates all FDA inspections, Notified Body and Corporate audits and other regulatory assessment. Ensures that pre and post-inspection/audit activities are completed including scheduling, record review, training, logistics, etc. Prepares responses to audit nonconformities for review by senior management.
- Leads QMS integration of new sites by performing comprehensive analysis and collaborating with BDB sites to identify applicability of procedures and training requirements.
- Support BDB Quality Management in the development of inspection and audit metrics and associated reports for distribution to key Corporate, Segment, Business Unit and Site personnel
- Performs all other duties and supports projects as assigned
- In depth knowledge of audit software systems in medium to large size medical device/pharmaceutical companies
- Ability to apply international regulations and standards of FDA QSR, ISO 13485, MDSAP, and EU IVDR standards
- Knowledge of quality system auditing
- Excellent verbal and written communication skills
- Proven track record to effectively collaborate and partner with all levels of management while maintaining an appropriate and formative style is critical.
- Strong critical think skill including timely issue identification, partner concern and resolution
- Ability to take care of ambiguity/uncertainty, multifaceted environment, and willingness to try new/complicated solutions
- Effective project management, conflict management and organizational skills are imperative.
- Bachelor’s degree in Engineering, Chemistry, Biology, or other related subject area
Certifications-One of the below certifications or equivalent: (Preferred)
- Certified Quality Auditor/ISO Lead Auditor Certified
- Certified Quality Engineer
- Certified Manager of Quality / Organizational Excellence
- A minimum of 13 years of work experience in the Quality organization of a Medical Device and/or Pharmaceutical company
- A proven track record of performing Medical Device or Pharmaceutical auditing or QS software systems (Trackwise, ET, Veeva, Pilgrim, EQMS)
- A minimum of 5 years of personnel management experience
Come Work With Us!
Why join us?
A career at BD means being part of a team that values your opinions and contributions and that empowers you to bring your authentic self to work. Here our associates can fulfill their life’s purpose through the work that they do every day.
You will learn and work alongside inspirational leaders and colleagues who are equally hardworking and committed to encouraging an inclusive, growth-centered, and exciting culture. Our Total Rewards program — which includes competitive pay, benefits, continuous learning, recognition, career growth, and life balance components — is crafted to support the varying needs of our diverse and global associates.
To learn more about BD visit https://jobs.bd.com/
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.
Primary Work LocationUSA CA - San Jose
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Advancing the world of health™
BD is one of the largest global medical technology companies in the world and is advancing the world of health™ by improving medical discovery, diagnostics and the delivery of care. BD helps customers enhance outcomes, lower costs, increase efficiencies, improve safety and expand access to health care.
BD is unique in how fully dedicated it is to a specific disease state. It makes it clear how the work we do directly impacts the daily lives of the patients we serve.
Senior Director Quality Management
To know that our products touch 30 million people with diabetes around the globe is powerful and fuels our teams to deliver best in class products to them each and every day.
It is inspiring to see BD products to be used globally to advance human healthcare.
Manager Medical Laboratory