Summary of Position with General Responsibilities:|
The incumbent is responsible for the development, implementation, and maintenance of information systems for Quality department. These activities include providing ongoing administration and maintenance of the company’s systems for quality performance metrics and associated product technical files.
Essential Job Functions:
Provide Quality Engineering representation on Product Development Teams.
Initiate new/revised documentation and tracks through approval cycles and implementation.
Participate on cross-functional teams to develop risk assessment.
Develop physical and functional test methods to ensure specifications are met.
Write and/or review 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.
Participate in internal and supplier audits.
Develop and implement procedures to provide easy to follow instructions.
Understand and follow company procedures on regulatory requirements.
Provide positive example and actively promote compliance to all standards.
Maintain a professional working relationship with internal and external customer and support staff.
Prepare and present project updates and technical discussions.
Education and/or Experience:
- Working knowledge of FDA GMP/GLP, Medical Device Directive, and ISO.
- Ability to make and present engineering decisions
- Comparative statistics
- Engineering cost analysis
- Ability to analyze and optimize manufacturing and quality systems
- Basic product, design & prototyping skills
- 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.
Currently enrolled in a Bachelors degree program in Engineering or a closely related technical field.
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.
C. R. Bard - 2 years ago
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