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Sr. Quality Engineer Arizona
Summary
This position develops, implements and improves new and
existing product quality requirements.
Primary Duties - Provide Quality
Engineering representation on Product Development Teams
- 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 provide 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 promote compliance to all standards
- Maintain a professional working
relationship with internal and external customers and support staff
- Prepare and present project
updates and technical discussions
Experience / Education
- Must read,
write and understand English.
- Must be detailed in handling information / data.
- Extensive knowledge of FDA GMP / GLP, Medical Device Directive, ASTM, AAMI, CEN, and ISO.
- A
minimum of a Bachelor’s degree in a technical field. Prefer a minimum of seven years experience in the medical field
or closely related industry or Master’s degree plus three years.
- Quality Engineering Certification
(ASQ) or equivalent.
Skills
- Must be able to work
in a team oriented, fast paced environment, with strong interpersonal skills
- Needs the ability
to make and present engineering decisions with demonstrated project management skills
- Must have
an understanding and be able to apply DOE
- Candidate must understand advanced statistics and
engineering cost analysis, with the ability to analyze and optimize manufacturing and quality systems
- Ability to lead cross functional teams, create and provide training, and create, review and coordinate test protocols
and reports
- Analyze and optimize manufacturing and quality systems
- Advanced
problem solving skills, and thorough software application skills
- Generate engineering proposals,
with oral and written presentation skills
- In-depth knowledge of regulatory requirements
- Ability to develop and control a budget
- Able to manage technical personnel
- Ability to perform design review functions
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