BD (Becton, Dickinson and Company) Staff Quality Engineer I, Supplier Quality in Franklin Lakes, New Jersey

Job Description SummaryReporting to the Director of Corporate Quality Engineering and Supplier Quality, the Staff Quality Engineer I/II, Supplier Quality is responsible for supporting the Global Supplier Quality Management (SQM) Program as developed and directed by the Associate Director of Supplier Quality. The Staff Quality Engineer I/II will work with the Associate Director to define the overall supplier quality management strategy.

The incumbent will also be responsible for supporting a standardized approach to SQM including global policies / procedures, quality agreements, forms /templates and supplier performance metrics etc. that are compliant with all applicable international regulatory requirements (e.g. FDA regulations, ISO 13485, European MDR/IVDR etc.). The Staff Quality Engineer I/II shall also be responsible for assuring effective coordination of supplier / vendor audits and global approved supplier list(s) in conjunction with the BD Business Units.

Job Description

Responsibilities:

  • Serve on and support the global Supplier Quality network towards the effective promotion and alignment of organizational goals to the company’s mission and vision

  • Work with the Associate Director of Supplier Quality to develop the strategy for global supplier quality management, including developing, implementing and driving continuous improvement for BD’s Global SQM Program

  • Continuously evaluate progress toward objectives adapting them to meet customer and business needs

  • Work with the Associate Director of Supplier Quality to lead and facilitate the Supplier Management Action Team (SMAT) ensuring timely and effective collection and reporting of data

  • Lead the administration and support of enterprise solutions supporting Supplier Quality Management, such as universal Approved Supplier List tool

  • Participate in project teams developing IT solutions supporting Supplier Quality Management

  • Participate in and/or lead Quality Improvement initiatives working with BD Suppliers

  • Maintain positive and cooperative communication and collaboration with all levels of employees, customer, contractors and vendors

  • Develop and share subject matter expert knowledge of global regulations

  • Significantly contribute to development of local and/or global strategies

  • Accomplishes tasks directly and through influence of experienced professional specialists and/or managers in partner Business Units

  • Coordinate, document, and ensure the implementation of BD’s standards regarding SQM Framework, including: supplier identification and selection; supplier evaluation and approval; supplier performance monitoring and supplier relationship management. The standards will serve as a framework for regulatory compliance and business optimization in accordance with the established supplier quality management strategy

  • Support the administration and coordination of the global supplier audit program and annual supplier audit plan, including suppliers incorporated though acquisition activity

  • Work with business, regional, and plant quality representatives to drive supplier management programs across the globe

  • Develop and coordinate the use of a database for the management and tracking of supplier information (e.g. Approved Supplier List) and monitoring of supplier performance (e.g. scorecards)

  • Develop and implement appropriate reporting metrics, structure and schedule -- Review and maintain supplier quality metrics for management review. React appropriately in a timely manner to correcting top quality issues

  • Provide operational due diligence assistance in the assessment (operational management, technology, product and process), certification, and performance improvements of suppliers

  • Partner with BD Procurement on the execution and continuous improvement of the BD Supplier Management program, including tactical support and problem-solving initiatives with suppliers

  • Ensures monitoring of watch lists and regulatory notices of field action for BD’s suppliers

Qualifications

  • BS degree in Life Sciences or Engineering preferred

  • Minimum of 8 years Medical Device, Pharmaceutical, Automotive or Aerospace industry experience with focus on Supplier Quality.

  • Knowledge of Medical Device or pharmaceutical regulatory standards such as cGMP 21CFR820, ISO 13485:2003 and/or others relevant to Medical Devices.

  • Experience working in a matrixed environment

  • Excellent skills in analytical thinking and problem solving.

  • Excellent written and oral communication skills.

  • Proficiency in Microsoft Office suite and statistical programs (i.e. MiniTab, SAS).

  • Demonstrated application of statistical methods.

  • Understanding of continuous improvement methodologies including lean, six sigma, and validation.

  • Experience directly interfacing and working with component, raw material and OEM suppliers.

  • Professional certification, e.g. American Society of Quality Certification in Quality Engineering or Reliability, Six Sigma Black Belt, Master Black Belt preferred.

  • Ability to travel domestically and internationally 5-20%

#LI-OPS

Primary Work LocationUSA NJ - Franklin Lakes

Additional LocationsUSA AZ - Nogales, USA AZ - Nogales, USA AZ - Tempe BPV Building 1, USA AZ - Tempe BPV Building 2, USA AZ - Tempe BPV Building 3, USA AZ - Tempe BPV Building 4, USA CA - Irvine Neomend, USA CA - San Diego (BDB), USA CA - San Diego (Diagnostic Sys.), USA CA - San Diego Bldg A&B, USA CA - San Diego TC Bldg C&D, USA CA - San Jose, USA CA - San Jose (Reagents), USA CT - Canaan, USA GA - Covington BMD, USA GA - Grayson, USA IL - Carol Stream, USA IL - Vernon Hills, USA MA - Andover, USA MD - Baltimore, USA MN - New Hope, USA NC - Burlington (Tripath Imaging), USA NC - Durham (Tripath Oncology), USA NC - Mebane, USA NC - Research Triangle Park {+ 22 more}

Work Shift

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