BD (Becton, Dickinson and Company) Principal Supplier Quality Engineer in Covington, Georgia

Job ID: 2018-12606

Career Level: experienced

Relocation: yes

Location: Covington,Georgia,United States


Bard has joined BD, together advancing the world of health. BD Urology & Critical Care, formerly Bard Medical, is looking to fill the position of Bilingual Customer Care Specialist located in Covington, GA.

Summary of Position with General Responsibilities:

The purpose of this position is to assist Quality Systems Management in creating and maintaining a strategic sourcing strategy for the Supplier Quality program. This includes partnering with Procurement, Operations and Quality to provide a strategy to protect revenue, bring resolution to supplier issues and provide the vision for supplier base consolidation.

Essential job Functions:

  • Defines strategy for supplier performance to alleviate pain points.

  • Functions as part of the Supplier Management Action Team (SMAT) at BD Interventional segment to rehabilitate or exit suppliers.

  • Interfaces with Operations, Quality, and other segment level functions to define overall strategy.

  • Develops supplier contracts for critical suppliers to ensure quality, delivery, capacity and manage change control.

  • Leads supplier relationship management for Urology & Critical Care (UCC).

  • Defines appropriate metrics/measurements for ongoing supplier analysis.

  • Develops methods to predict supplier risk and identify opportunities to reduce/retire the risk.

  • Works with critical suppliers and SMAT to reduce costs through improvement plans.

  • Ensures project deadlines and budgets are met.

  • Reviews QA, ISO and other audit reports for suppliers subject to FDA regulations to assist with identification of risks and opportunities.

  • May perform or direct the performance of internal and external Supplier Quality System audits and qualification audits as part of supplier assessment and development.

  • Manages a team of Supplier QEs to effectively participate in SMAT as well as manage the day to day supplier program at UCC

  • Other duties may be assigned.

Basic Qualifications:

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed in this section and below are representative of the knowledge, skill and/or ability required.

  • Ability to perform engineering work of a broad nature with little or no direction from Quality Management. Generally, receives guidance on novel or controversial problems.

  • Extensive knowledge of medical device regulations, industry or international standards, including management responsibility. Ability to understand matrix organizations and be able to implement systemic changes to enhance product quality and improve business efficiency. Ability to interface with regulatory bodies to present technical information.

  • Comprehensive knowledge of quality systems and relationship to business.

  • Has experience in writing protocols/validations and has fundamental knowledge of validation principles.

  • Understands basic applied statistics, statistical sampling plans, and statistical process control and advanced statistical methodologies such as DOE and Taguchi.

  • Ability to serve in leadership roles on projects or assignments.

  • Comprehensive understanding of auditing principles and ability to perform as a lead auditor, if necessary.

  • Ability to participate and provide leadership on teams and maintain positive work environment with those teams. Understands team functions, leadership techniques and project management methodologies.

  • Broad knowledge of manufacturing processes.

  • Excellent communication skills (verbal, written, and presentation). Understands how to present information dependent upon the level of the audience.

  • Understands Fundamentals of Engineering Principles.

  • Ability to effectively manage time.

  • Ability to handle multiple task assignments.

  • Ability to translate quality requirements into product specifications.

  • Ability to interpret Regulations, Corporate, Division and Department Procedures.

Education and/or Experience:

  • B.S. in Engineering, Engineering Technology, or Science a minimum.

  • American Society of Quality (ASQ) certification (CQE, CQA, CQM, etc.) preferred.

  • Minimum 10 years of experience with FDA regulated industry including 5 years in Supplier Quality.

  • Direct experience with FDA QSR and ISO 13485 compliance.

Physical Demands:

Employee may be required to sit, bend, stoop, use keyboard, see, talk and hear. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Work Environment:

This position works in a normal office environment. The noise level in the work environment is quiet to moderate.

Some travel is required. When traveling to supplier sites or other BD sites, the work environment will be specific to the area under evaluation.

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