C. R. Bard, Inc.

Quality Engineering Manager

2 weeks ago
Industry / Category
Medical Device/ Quality
Job ID
2017-10854
Career Level
management
Division
Bard Peripheral Vascular
Relocation
TBD
US-UT-Salt Lake City

Overview

Bard Peripheral Vascular – where a tradition of vascular innovation spans decades of focusing on improving the quality of patients’ lives. From C. R. Bard’s first arterial prosthesis developed in 1954, Bard and the division of Bard Peripheral Vascular have demonstrated commitment to innovative medical technology by introducing surgical and interventional devices for peripheral vascular patency, while providing exceptional service and support to surgeons, interventionalists and radiologists. Bard Peripheral Vascular is an affirmative action, equal opportunity employer that values and actively seeks diversity in the workforce. #LI-SF1

Summary of Position with General Responsibilities

The Quality Engineering manager will provide oversight and support for quality staff whose primary responsibility is risk identification and consistency of approach identifying risk for new product development.

Essential Job Functions

  1. Responsible for ensuring compliance with all Federal, State, local and company regulations, policies and procedures.
  2. Manage quality resources assigned to new product development programs.
  3. Ensure appropriate QE representation on product development teams.
  4. Provide QE resources required for test method development and validation, product verification and validation activities, coordination of reliability testing associated with new product development, evaluation of data for statistical validity, component qualifications, process capability studies, equipment qualifications, and process validations.
  5. Facilitate risk management process in compliance to appropriate external standards and corporate policies. Provide technical support to NPD teams in generating risk files for new products.
  6. Provide QE resources required for coordination of sterilization, biocompatibility, and shelf-life determination studies.
  7. Lead failure investigations for product failures encountered during the new product development.
  8. Ensure QE support of field assurance investigations as required.
  9. Maintain an up to date knowledge in the areas of quality assurance, regulatory compliance, design controls, risk management, statistical techniques and in the company products, policies, and procedures.
  10. Recruit and develop well trained quality professionals. Mentor employees and identify their training priorities.
  11. Facilitate compliance to applicable internal and external requirements during the product development cycle and commercialization of new products.
  12. Collaborate with the R&D organization to help facilitate the successful execution of the New Product Development Process and launching of robust products.
  13. Responsible and accountable for Quality Engineering (QE) deliverables required within the product development program and for ensuring that NPD projects are properly resourced with well trained and capable quality professionals.
  14. Recruit and develop quality engineering resources as required.
  15. Provide expertise in the areas of quality assurance, regulatory compliance, design controls, risk management, and statistical techniques.
  16. Coordinate quality activities with Bard divisions and manufacturing sites during the product development cycle, design transfer, and commercialization of new products.

           

Basic Qualifications

Ability to effectively deal and negotiate with members of Bard multi-functional project teams and representatives of various government and regulatory agencies.

Ability to travel within the USA and internationally.

Must read, write and understand English. Must be exact in handling detailed information/data.

Working knowledge of ISO, Medical Device Directive, GMP/QSR and other applicable regulations.        

Additional Desirable Qualifications Skills and Knowledge

Strong influence management, conflict resolution and communication skills.

Education and/or Experience

BS Degree in Science or Engineering (or equivalent).

Ten or more years of experience with Class II or Class III medical devices including a minimum of five years of supervisory experience.

At least five years of applicable statistical experience.

Design/Process Excellence or CQE certification is required.

Working knowledge of ISO, Medical Device Directive, GMP/QSR and other applicable regulations.

Physical Demands

While performing the duties of this job, the employee is regularly required to stand, walk, sit and use hands to manipulate, handle or feel objects, tools, controls and office equipment. The employee frequently is required to talk and hear.The employee is occasionally required to reach with hands and arms and stoop, kneel or crouch.

Work Environment

While performing the duties of this job, the employee may be in an open cubicle environment.       Candidate must be able to work in a team-oriented, fast-paced environment. Bard Peripheral Vascular is an affirmative action, equal opportunity employer that values and actively seeks diversity in the workforce.

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