SR. QUALITY ENGINEER
Adecco - Tempe, AZ

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Adecco Engineering and Technical, a division of the world leader in the recruitment of engineering and information technologies professionals, has an immediate career opportunity for a Sr. Quality Engineer on a Direct Hire basis, with a leader in the peripheral vascular industry.

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

Responsibilities:
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.

Qualifications:
1. 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.

Requirements:
Prefer a minimum of 6 years experience in the medical field or closely related industry or a Masters Degree plus three years.
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.

Work conditions:
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.

While performing the duties of this job, the employee may be in an open cubicle environment. 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.

Further information about careers and openings at Adecco Engineering & Technical can be found on our website: http://www.adeccotechnical.com/

Adecco Engineering & Technical is a Fortune Global 500 company and the global leader in HR services. Our group connects over 700,000 associates with our business clients each day through our 6,600 offices in over 70 countries and territories around the world. We offer employment opportunities at any stage in your professional career. Contact us today to discuss available contract and direct hire positions. Adecco Engineering and Technical is an Equal Opportunity Employer.

Adecco - 14 months ago - save job - block
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