NOW HIRING: Senior / Principal Quality Engineer
- Provide Quality Engineering representation on Product Development Teams.
- Initiate new/revised documentation and track through approval cycles and implementation.
- Participate and/or 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 device failure analysis for complaint investigations.
- Understand and follow company procedures on regulatory requirements.
- Provide positive example and actively promote compliance to company and industry standards.
- Maintain a professional working relationship with internal and external customer and support staff.
- Prepare and present project updates and technical discussions.
- Bachelors degree in Engineering or a closely related technical field.
- A minimum of 4 years experience in the medical device development or closely related industry or Masters Degree plus two years.
- Quality Engineering Certification (ASQ) or equivalent, desired.
- Working knowledge of FDA GMP/GLP, Medical Device Directive, ASTM, AAMI, IEC and ISO.
- New product development QA support of electro-mechanical medical device experience desired.
- Working knowledge of; process validation requirements and application of comparative statistics and other quality engineering tools.
- Experience supporting product, design & prototyping a plus.
Additional Skills & Abilities:
- Ability to create, review and coordinate test protocols and reports
- Ability to generate engineering proposals
- Strong interpersonal skills
- Problem solving ability
- Oral and written presentation skills
- Ability to lead cross functional teams
- Understanding of regulatory requirements
- Ability to make and present engineering decisions
This job description is intended as a summary of the primary responsibilities of and qualifications for this position. It is not intended as inclusive of all duties an individual in this position might be asked to perform or of all qualifications that may be required either now or in the future.
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3 years ago / No Comments