Job Description Summary

The Plant Associate Quality Director serves as the Plant Management Representative and as a member of the site leadership team with responsibility for maintaining a quality system that meets all applicable regulatory requirements and ensuring that materials produced by the plant conform to established BD specifications.

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.

The Plant Associate Quality Director serves as the Plant Management Representative and as a member of the site leadership team with responsibility for maintaining a quality system that meets all applicable regulatory requirements and ensuring that materials produced by the plant conform to established BD specifications.

The essential functions of this position include but are not limited to:

• As a member of the Specimen Management (SM)  quality leadership team, the plant quality assurance associate director is responsible for contributing towards and supporting the unit quality objectives and initiatives including the standardization and simplification of quality systems.

• Establishes plant quality goals and objectives, monitors progress towards meeting these goals and objectives and takes action necessary to address unfavorable trends.  Ensures rapid communication and visibility of emerging quality issues among the plant leadership team and unit quality leadership.

• Ensures that plant quality assurance policies and procedures align with SM business and all relevant applicable regulatory requirements, such as FDA/GMP/ISO. In addition, suggests improvements to unit policies and procedures as necessary.

• As management representative, meets and escorts regulatory agency inspectors such as FDA & ISO, customer visits and audits, and unit or corporate auditors.  Maintains records of all required licenses, permits and registrations as required by regulatory agencies and follows up on renewals and compliance with stated conditions.  May delegate the Authority to Accept Notice of Inspection (FDA form 482) on behalf of the plant quality associate director.

• Ensures that laboratories used to test product maintain a reliable and consistent level of operation and an adequate stock of laboratory reagents, supplies, instruments, and tools.

• Accountable for adequacy and availability of quality engineering resources to support quality assurance activities including trending and analysis of quality data.

• The plant quality associate director is responsible for establishing and maintaining the plant quality system and ensuring that the following elements are effective.

• Incoming materials and release of final product – all testing conforms to established specifications, inspections are completed, and documentation maintained per established procedures.   Responsible for auditing device history records and associated testing records and assures that that documentation is properly recorded prior to authorizing the release of raw materials and finished goods.  Maintains a library of Device History Records and retained samples, as directed by FDA/GMP/ISO regulations.

• Calibration – the plant wide calibration program including the frequency and the documentation comply with currently approved procedures and with FDA/GMP/ISO guidelines.

• Validation - new processes and process changes, including process, molding, software, and AME, are properly validated, are supported by approved validation protocols, and that validation reports are approved using appropriate supporting documentation. 

• Documentation – plant quality system and manufacturing documentation is maintained with currently approved versions, as established by the SM business Engineering Change Order (ECO) procedures.  Assures proper security of master records and officially distributed copies, and that obsolete or earlier versions of the documents are removed from users and destroyed.

• Internal Audits - periodic internal audits are conducted to assure compliance with currently approved procedures, policies, and FDA/GMP/ISO regulations.

• Supplier Management – supports periodic vendor audits to maintain the vendor rating programs and that raw material quality meets or exceeds established specifications.

• Customer Complaints – customer complaints (PIRS) are properly investigated for the products manufactured at the plant. Assures prompt investigation, resolution, corrective actions and reply actions, ensuring that relevant associated documentation is completed.

• Management Review – facilitates periodic management reviews to verify the suitability and effectiveness of the quality system to meet the BD quality policy and plant quality objectives.

• CAPA – provides leadership to ensure proper management focus on CAPA, appropriate quality issues are elevated to a CAPA, adequate resources are available to manage CAIDS and root causes are identified and effectively addressed to prevent recurrence

• prior to implementing changes.

• Sterilization – proper expertise is available to manage sterilization activities and product meets sterility claims.

• Environmental Monitoring – an effective environmental monitoring program is documented, implemented, and recorded.

• Graphics / Labeling – an effective process is used to manage labeling activities including storage, inspection, label integrity and control.

• Nonconforming Materials – an effective and efficient process exists to document, evaluate, segregate, and disposition nonconforming product.  The Plant Quality Assurance Manager is accountable for disposition of nonconforming materials.

• Training – an effective and efficient process is in place to identify required competencies for each defined role and that associates are competent to perform their assigned roles.

• Prepares budgets and maintains a cost control under their areas of responsibilities.

• Assists and contributes to the cost reduction, process improvement, accident prevention, and environmental awareness programs and projects.

• Evaluating and reporting the performance of the Quality Management System and the needs for improvement to Management.

SAFETY AND ENVIRONMENTAL PERFORMANCE STANDARDS

• Ensure safety and environmental tours of area are conducted.

• Establish and report on annual safety and environmental goals as set out in Standards of Performance.  Goals to be specific, measurable, trackable, and include as many parameters as possible.

• Discuss and document pertinent safety and environmental management topics at staff meetings.

• Ensure that management review meetings of lost time injuries, significant damage, and high-potential incidents are held no later than the next working day.

OTHER RESPONSIBILITIES

Other responsibilities of this position include but are not limited to:

• Follows, and responsible for enforcing, all local, state, federal and BD safety regulations, policies/procedures.

• Performs other job-related duties as assigned.

• Observes all safety, environmental and quality system standards.

• Frequent contact with other executives and visitors. Constant interaction with all levels within the plant.

• Manages work related confidential data. Must be very discreet when releasing information whose disclosure could affect internal relationships.

• All requirements are subject to possible modification to reasonably accommodate individuals with disabilities.  Some requirements may exclude individuals who pose a direct threat or significant risk to the health and safety of themselves or other employees.

• This job description in no way states or implies that these are the only duties to be performed by the employee occupying this position.  Employees will be required to follow any other job-related instructions and to perform any other job-related duties requested by their supervisor. 

• Requirements are representative of minimum levels of knowledge, skills and/or abilities.  To perform this job successfully, the incumbent will possess the abilities or aptitudes to perform each duty proficiently.

• This document does not create an employment contract, implied or otherwise, other than an "at will" employment relationship

Qualifications

Education and Experience:

• AssociatesDegree required. BachelorDegree in Engineering, Science, or related technical field preferred

• Six Sigma or Lean certification desired.

• Five (5) to seven (7) years’ experience in Quality Assurance

• Two (2) years supervisory experience in Quality Assurance

• Desire Quality Assurance experience to be in pharmaceutical and/or medical device industries

• Experience with GMP/ISO compliance and documentation, and FDA Regulations.

Knowledge, Skills, and Abilities:

• Must be able to read, write and speak English fluently.

• Knowledge of manufacturing systems, medical products and related materials, quality testing and quality auditing.

• Familiar with Federal and State regulations regarding manufacture of medical devices and operation of Cobalt irradiator.

• Change control – plant changes are properly reviewed and approved prior to execution and all appropriate verification and/or validation activities are completed

• Apply principles of logical or scientific thinking to define problems, collect data, establish facts, and draw valid conclusions.

• Interpret drawings and technical instructions furnished in written or oral form.

• Prepare business letters, expositions, summaries, and reports using standard formats and conforming to rules of punctuation and grammar.

• Participate in panel discussions, prepare, and deliver presentations.

• Conduct training sessions.

• Communicate verbal instructions and requirements in a clear, effective manner.

• Expert knowledge and understanding of Good Manufacturing Practices (cGMP)

• Management skills with ability to lead and mentor others effectively while advocating a quality environment.

Work Environment:

• BD is a smoke-free campus.  Smoking and the use of electronic smoking devices, marijuana, or tobacco products are not allowed on BD property, grounds or in the parking areas.  We appreciate your cooperation in adhering to this policy

• False eyelashes, press-on fingernails, and Jewelry is not allowed on the production floor including dermals.  Any associate wearing dermals will be required to cover them while working on the production floor. 

• Shoes are required to be Steel Toe and non-slip for all associates while on the production floor for safety purposes.

At BD, we prioritize on-site collaboration because we believe it fosters creativity, innovation, and effective problem-solving, which are essential in the fast-paced healthcare industry. For most roles, we require a minimum of 4 days of in-office presence per week to maintain our culture of excellence and ensure smooth operations, while also recognizing the importance of flexibility and work-life balance. Remote or field-based positions will have different workplace arrangements which will be indicated in the job posting.

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.  

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. 

Required Skills

Optional Skills

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Primary Work Location

USA SC - Sumter

Additional Locations

Work Shift