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Company Info

Bard Peripheral Vascular
Tempe, AZ, United States

Company Profile



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Quality Engineer 1 - Tempe AZ Job ID: 2017-9934


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Job ID:

3568273

Location:

Tempe 

Job Category:

Engineering, Health Care, QA-Quality Control
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States:

AZ

Employment Type:

Full Time

Posted:

04.20.2017
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Job Description:

Overview:

Bard Peripheral Vascular is located Tempe, AZ – 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-JC1

 

Summary of Position with General Responsibilities:

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

 

Essential Job Functions:

  1. Assess risk associated with non-conforming material and determine disposition of affected product.
  2. Initiate new/revised documentation and tracks through approval cycles and implementation.
  3. Participate on cross-functional teams to develop risk assessment.
  4. Develop physical and functional test methods to ensure specifications are met.
  5. Write and/or review design verification and validation protocols and reports.
  6. Develop processes validation requirements (IQ, OQ, PQ) and equipment qualifications.
  7. Conduct and /or coordinate testing outlined in protocols and test methods.
  8. Perform process improvement, control and monitoring on manufacturing processes.
  9. Provide technical direction during design transfer activities.
  10. Conduct complaint investigations.
  11. Initiate Quality Event and CAPA investigations. Develop action plans to correct identified issues.
  12. Participate and provide input to training on department/division procedures, and policies.
  13. Participate in project planning, budgeting, scheduling and tracking.
  14. Participate in internal and supplier audits.
  15. Develop and implement procedures to provide easy to follow instructions.
  16. Understand and follow company procedures on regulatory requirements.
  17. Provide positive example and actively promote compliance to all standards.
  18. Maintain a professional working relationship with internal and external customer and support staff.
  19. Prepare and present project updates and technical discussions.
 

Job Requirements:

Basic Qualifications:

Working knowledge of FDA GMP/GLP, Medical Device Directive, and ISO.

Ability to make and present engineering decisions

Strong interpersonal skills

Comparative statistics

Engineering cost analysis

Ability to analyze and optimize manufacturing and quality systems

Ability to create and provide training

Software application skills

Problem solving ability

Ability to create, review and coordinate test protocols and reports

Ability to generate engineering proposals

Oral and written presentation skills

Ability to work on cross functional teams

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

Basic product, design & prototyping skills  

Proficient with Microsoft Excel

Familiar with Minitab and Statistical Analysis   

 

Additional Desirable Qualifications Skills and Knowledge:

 Prefer two years experience in the medical field or closely related industry.

 

Education and/or Experience:

A minimum of a Bachelors degree in a technical field.

Two years experience in the medical field or closely related industry.

 

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.

CLICK ON LINK BELOW TO BE DIRECTED TO OUR WEBSITE FOR YOUR APPLICATION PROCESS: https://jobs-crbard.icims.com/jobs/9934/quality-engineer-i/job
 

Work Environment:

While performing the duties of this job, the employee may be in an open cubicle environment as well as in a cleanroom environment on a medical device manufacturing floor. 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.

Security Clearance:

NO Security Clearance




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