C. R. Bard, Inc.

Quality Engineer II

2 months ago
Industry / Category
Quality Engineer II
Job ID
2017-10715
Career Level
experienced
Division
Lutonix, New Hope, MN
Relocation
No
US-MN-New Hope

Overview

This position develops implements and improves new and existing product quality requirements within a dynamic combination medical device / pharmaceutical R&D Technology Center.

Essential Job Functions

  • Provide Quality Engineering representation on Product Development Teams.
  • Initiate new/revised documentation and track through approval cycles and implementation.
  • Participate and/or lead cross-functional teams to develop risk assessment.
  • Develop physical and functional test methods to ensure specifications are met.
  • Write, review and approve design verification and validation protocols and reports.
  • Develop processes validation requirements (IQ, OQ, PQ) and equipment qualifications.
  • Conduct and /or coordinate testing outlined in protocols and test methods.
  • Perform process improvement, control and monitoring on manufacturing processes.
  • Provide technical direction during design transfer activities.
  • Conduct complaint investigations.
  • Participate and provide input to training on department/division procedures, and policies.
  • Participate in project planning, budgeting, scheduling and tracking.
  • Coordinate and perform internal and supplier audits.
  • Develop and implement procedures to comply with corporate and industry standards.
  • Understand and follow company procedures on regulatory requirements.
  • Provide support to the regulatory department in writing technical submissions.
  • Provide positive example and actively promote compliance to division, corporate and industry standards.
  • Maintain a professional working relationship with internal and external customer and support staff.
  • Prepare and present project updates and technical discussions.

 

 

Basic Qualifications

  • Bachelors degree in Engineering or a closely related technical field.
  • A minimum of 4 years experience in the medical device development or closely related industry or Masters Degree plus two years.
  • Quality Engineering Certification (ASQ) or equivalent, desired.
  • Working knowledge of FDA GMP/GLP, Medical Device Directive, ASTM, AAMI, CEN and ISO.
  • Combination device/pharmaceutical and coating technology experience preferred.    
  • Working knowledge of; process validation requirements and application, comparative statistics, risk management, internal and supplier audits.
  • Experience supporting product, design & prototyping a plus.

 

Physical Demands

While performing the duties of this job, the employee may be required to stand, walk, sit and use hands to manipulate tools, controls and office equipment. Work may involve continuous computer use with repetitive motion to wrists, hands and fingers.  The employee frequently is required to see, talk and hear.  The employee is occasionally required to bend, lift, reach or stoop.  In addition, the employee must have visual acuity and color perception to conduct clean-room and laboratory duties.  Employee must be able to wear personal protective equipment.  Inability to meet one or more of these physical demands will not automatically disqualify a candidate or employee from the position.  Upon request, the company may make reasonable accommodations. 

Work Environment

While performing the duties of this job, the employee may work with chemicals and/or biological materials. The employee may be in an open cubicle environment and must be able to work in a team-oriented, fast-paced environment.  Bard Lutonix is an affirmative action, equal opportunity employer that values and actively seeks diversity in the workforce.

 

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