Senior Quality Engineer
C. R. Bard - Tempe, AZ

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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.

Summary of Position with General Responsibilities:
This position develops, implements and improves new and existing product quality requirements.

Essential Job Functions:
1. Provide Quality Engineering representation on Product Development Teams.
2. Initiate new or revised documentation
3. Lead cross-functional teams to develop risk assessment.
4. Develop physical and functional test methods to ensure specifications are met.
5. Write, review and approve 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. Participate and provides input to training on department/division procedures, and policies.
12. Participate in project planning, budgeting, scheduling and tracking.
13. Coordinate and lead internal and supplier audits.
14. Develop and implement procedures to comply with corporate and industry standards.
15. Understand and follow company procedures on regulatory requirements.
16. Provide support to the regulatory department in writing technical submissions.
17. Provide positive example and actively promotes 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.

Basic Qualifications:
Ability to make and present engineering decisions
2. Strong interpersonal skills
3. Demonstrated Project Management skills
4. Advanced statistics
4.1. Understanding and application of DOE
5. Ability to lead cross functional teams
6. Engineering cost analysis
7. Ability to analyze and optimize manufacturing and quality systems
8. Advanced product, design & prototyping skills
9. Ability to create and provide training
10. Software application skills
11. Advanced problem solving skills
12. Ability to create, review and coordinate test protocols and reports
13. Ability to generate engineering proposals
14. Oral and written presentation skills
15. In-depth knowledge of regulatory requirements
16. Ability to develop and control a budget
17. Ability to manage technical personnel
18. Ability to perform design review functions
19.Must read, write and understand English. Must be detailed in handling information/data.

Additional Desirable Qualifications Skills and Knowledge:
Prefer a minimum of 6 years experience in the medical field or closely related industry or a Masters Degree plus three years.

Education and/or Experience:
A minimum of a Bachelors degree in a technical field.
Prefer a minimum of 6 years experience in the medical field or closely related industry or a Masters Degree plus three years.
Quality Engineering Certification (ASQ) or equivalent.

Extensive knowledge of FDA GMP/GLP, Medical Device Directive, ASTM, AAMI, CEN and ISO.

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.

About this company
9 reviews
C. R. Bard is no upstart in the world of medical devices. The company has been in the business for more than a century and introduced the...