C. R. Bard, Inc.

Associate Director / Director, Advanced Quality Engineering

1 month ago
Industry / Category
Medical Device / Quality Assurance
Job ID
2017-10746
Career Level
management
Division
Warwick, RI / Davol Inc.
Relocation
Yes
US-RI-Warwick

Overview

Bard Davol Inc., a subsidiary of C. R. Bard, Inc., located in Rhode Island, is a leading developer, manufacturer, and marketer of innovative, life-enhancing medical technologies. We focus our business on key surgical specialties, including Soft Tissue Repair, Surgical Fixation, Biomaterials and Orthopedic/Wound Management Irrigation.

Our company has a strong tradition of developing our employees to learn, grow and excel.  We are continually building our team with qualified, team oriented individuals to enhance the success of our company.

Davol headquarters is situated in a central location, surrounded by a scenic coastline with easy access to T.F. Green Airport, AMTRAK Train Stations and Route 95, a major highway connecting to Providence, Connecticut, Boston and New York City within a short amount of time.                 

Summary of Position with General Responsibilities

The main responsibilities of the position are to provide strategic vision and tactical implementation of the quality engineering role in support of new product development (NPD).  The position will represent the QA team as a spokesperson and leader within NPD.  Davol has a wide range of products and technologies, and the leader must be able to adapt their quality assurance skill set and apply it to a breadth of difficult technical issues. 

 

The position requires strategic vision in building the organization’s skill sets and capabilities, as well as adapting the QMS to meet the ever changing needs of the business.

 

The leader must have the ability to influence internal and external relationships, including the quality engineering staff, functional peers, upper management and suppliers.  The leader will work closely with R&D, Manufacturing, Marketing and Regulatory Affairs, to collaborate on complex issues and apply critical thinking to each unique situation.   

Essential Job Functions

Design Assurance:  Manage and mentor the AQE staff in support of NPD activities:

  • Creation of design inputs.
  • Evaluation and approval of new product designs, specifications and product test procedures.
  • Evaluation of HF&U activities, including Formative and Summative studies.
  • Designing and executing statistical engineering experiments to compare design alternatives, compare proposed product with competitive products and evaluate performance.
  • Co-ordination of biocompatibility testing on all new materials.
  • Development of test methods and test method validations for the adequate evaluation of designs.
  • Development and execution of Design Verification plans.
  • Development and coordination of Risk Management activities, including DFMEA.
  • Development of accelerated and real time shelf life plans.
  • Development of supplier and component qualification plans in support of NPD projects
  • Providing the smooth transition of new products to manufacturing through the continuous review of all quality systems, inspection data and product yields.
  • Special projects as assigned.

 

Quality Engineering:  Manage and mentor the AQE staff in support of NPD activities:

  • Developing process and product controls to assure the consistent manufacturing of products to established specifications.
  • Development of processes and equipment validation plans.
  • Support failure investigation process to identify root cause of product, process, and system non-conformances in order to drive continuous improvement as well as corrective and preventive actions.
  • Develop and improve quality systems to facilitate business and quality objectives and compliance review and resolution process to ensure the organization is alerted to issues in time to resolve potential adverse effects on the customer, company, or business.
  • Special projects as assigned.

Basic Qualifications

  • Bachelor Degree in Engineering or Technical Science required.
  • Associate Director: Minimum of 6 years’ experience managing Sr. level AQEs and/or a Franchise team in an Engineering environment; Minimum of 8 years’ experience in a product development environment; Minimum of 6 years’ experience in the medical device industry.
  • Director: Minimum of 10 years’ experience managing Sr. level AQEs and/or a Franchise team in an Engineering environment; Minimum of 10 years’ experience in a product development environment; Minimum of 8 years’ experience in the medical device industry.
  • Formal course work in Statistical Quality Control.
  • Ability to apply broad technical, business, and compliance knowledge to improve business results.
  • Ability to effectively negotiate and influence upper management, other departments, and industry.
  • Conceptual and practical knowledge of applicable processes, systems and validation processes and systems.
  • Ability to adjust to and assimilate new technologies and innovations.
  • Effective communication skills.
  • Effective problem solving techniques
  • Demonstrated leadership skills.
  • Ability to travel approximately 20% of time.

Additional Desirable Qualifications Skills and Knowledge

  • Master’s Degree strongly preferred.

Education and/or Experience

*Determination of level will be based upon years of experience and demonstrated knowledge/skills.


Davol Inc. and C.R. Bard, Inc. are Affirmative Action/Equal Opportunity Employers, M/F/D/V.  VEVRAA Federal Contractor.

 

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