C. R. Bard, Inc.

Supplier Quality Engineer II

2 months ago
Industry / Category
Quality Engineer II/Quality Assurance
Job ID
2017-9856
Career Level
experienced
Division
Bard Medical
Relocation
Yes
US-GA-Covington

Overview

C.R. Bard’s story began with one product in turn-of-the-century New York City. We now have offices across the world, including the Bard Medical Division (BMD) headquartered in Covington, Georgia. BMD is a market leader in Urology products, holding leading market position in nearly all product groups in which we compete.

 

Summary of Position with General Responsibilities

The purpose of this position is to assist Quality Systems Management in maintaining the Supplier Management System. This includes assisting other Quality Systems personnel with the proper tools and guidance to be successful in performing their work. Additionally, the Supplier Management Engineer II functions as a subject-matter resource for Quality Systems, internal supplier quality assurance, Operations, sterilization and external suppliers.

Essential Job Functions

  • Performs internal or supplier quality system audits.
  • Create & maintain supplier contact database; plan for incorporation of this information into Master Control.
  • Update supplier profiles for all Class C suppliers (may also include performance assessment of Class C suppliers). Evaluate profiles for A and B suppliers for compliance to procedure.
  • Conduct standardized performance assessments with new “benchmark” template (assessments) and ensure minimum required information is submitted with the audit file (on-site audits).
  • Identify the need for and facilitate completion of memos (or other documentation) to address any existing gaps in the supplier files within the record retention period.
  • Generate and maintain a database for existing/current supplier management documentation; generate electronic copies for backup/file storage; archive/facilitate off-site storage of physical files.
  • Create and maintain audit management database (audit date, report date, AAP date, CA/PA due dates, completion dates, EV dates, closure date, etc.). Also include documentation of local Supplier Management Committee (SMC) review and approval.
  • Facilitate transition of paper-based to electronic-based systems (audit schedules, SCAR log, audit records (notification, agenda, executive summary, detailed summary, AAP, supplier profile, performance assessments, debarment checks, warning letter search, scorecards, memos, etc.).
  • Manage Supplier Management Change Requests (Audit Schedule, ASL, SCAR log, etc.).
  • Identify linkages between supplier, material, specification, risk analysis and plan for incorporation of this information into Master Control.
  • Creation and maintenance of report cards for entire ASL, to include expansion of ASL (internal suppliers, non-inventory suppliers, consultants, contractors, and others, as appropriate).
  • Manage the ASL in three categories – external Bard Medical Division suppliers; external Bard Shared Services suppliers; internal Bard Medical Division suppliers. Assist with documentation and communication associated with NCs, SCARs, AAPs, objective evidence.
  • Develop an auditor training program.
  • Prepare reports for SMC meetings – Component Quality Rating, Audit Rating, SCAR Rating, Approval Status Rating, MRR updates, Audit updates, SCAR updates, Approval Status updates.
  • Cross train in other QS responsibilities, as appropriate.

Basic Qualifications

To be successful in this role, 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. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

 

  • Ability to perform engineering work of a broad nature with minimal oversight and direction from Quality Management. Generally, receives guidance on novel or controversial problems.
  • Demonstrated extensive knowledge of medical device regulations, industry and international standards.. Ability to understand Division and Plant Quality Systems 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 the relationship to the 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 through influence roles on projects or assignments.
  • Comprehensive understanding of auditing principles and ability to perform as a lead auditor.
  • 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 basic 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, as well as, 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.)
  • Minimum 5 years of experience with FDA regulated industry including 3 years in QA preferably Supplier Quality.

Physical Demands

Employee may be required to sit, bend, stoop, use keyboard, see, talk and hear. May occasionally lift objects up to 25 lbs. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

 

 

Work Environment

Normal office environment - noise level is quiet to moderate - frequent travel is required - when traveling to clinical sites or hospitals, work environment will be specific to the area under evaluation.

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