BD (Becton, Dickinson and Company) Senior Supplier Quality Engineer in Covington, Georgia
Job ID: 2018-12608
Career Level: experienced
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 Senior Supplier Quality Engineer in Covington, GA.
Summary of Position with General Responsibilities:
The purpose of this position is to assist the Principle Supplier Quality Engineer with 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:
Assists with defining the 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.
Under the direction of the Principle QE, develops supplier contracts for critical suppliers to ensure quality, delivery, capacity and manage change control.
Supports supplier relationship management for Urology & Critical Care (UCC).
Assists with defining appropriate metrics/measurements for ongoing supplier analysis.
Works with critical suppliers and SMAT to reduce costs through improvement plans.
Reviews QA, ISO and other audit reports for suppliers subject to FDA regulations to assist with identification of risks and opportunities.
May perform internal and external Supplier Quality System audits and qualification audits as part of supplier assessment and development
Other duties may be assigned.
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 minimal direction from Quality Management.
In depth knowledge of medical device regulations, industry or international standards. 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 8 years of experience with FDA regulated industry including 3 to 5 years in Supplier Quality.
Direct experience with FDA QSR and ISO 13485 compliance.
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.
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