C. R. Bard, Inc.

Sr. Quality Engineer

1 month ago
Industry / Category
Quality Engineer
Job ID
Career Level
Lutonix, New Hope, MN
US-MN-New Hope

Summary of Position with General Responsibilities

This position develops, implements, and improves new and existing product quality requirements.

Essential Job Functions

  • Support cross-functional drug-device combination product development projects from concept through commercialization.
  • Provide Quality Engineering representation on Product Development Teams.
  • Carry responsibility for quality systems, compliance and Six Sigma/Lean projects.
  • Use advanced skills to design experiments using DOE methodology and analyze the test results using statistical tools. Lead efforts in developing methods to test components and finished products.
  • Initiate new or revised documentation
  • 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 provides input to training on department/division procedures, and policies.
  • Participate in project planning, budgeting, scheduling and tracking.
  • Coordinate and lead 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 promotes compliance to all standards.
  • Maintain a professional working relationship with internal and external customer and support staff.
  • Prepare and present project updates and technical discussions.

Basic Qualifications

  • Ability to make and present engineering decisions
  • Strong interpersonal skills
  • Demonstrated Project Management skills
  • Advanced statistics and understanding and application of DOE
  • Ability to lead cross functional teams
  • Engineering cost analysis
  • Ability to analyze and optimize manufacturing and quality systems
  • Advanced product, design & prototyping skills
  • Ability to create and provide training
  • Software application skills
  • Advanced problem solving skills
  • Ability to create, review and coordinate test protocols and reports
  • Ability to generate engineering proposals
  • Oral and written presentation skills
  • In-depth knowledge of regulatory requirements
  • Ability to develop and control a budget
  • Ability to manage technical personnel
  • Ability to perform design review functions


Education and/or Experience


  • A minimum of a Bachelors degree in a technical field.
  • A minimum of 6 years experience in the medical device industry or other highly regulated industry; or a Masters Degree plus three years.
  • Quality Engineering Certification (ASQ) or equivalent.
  • Extensive knowledge of FDA GMP/GLP, ICH, Medical Device Directive, ASTM, AAMI, CEN and ISO guidances and requirements.


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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