Overview
Facilitate compliance to applicable internal and external requirements for the Design Control process. Collaborate with R&D, Regulatory, Clinical, Manufacturing, and other departments to help facilitate the successful execution of the Design Control and Risk Management processes.
Accountable for Design Assurance Engineering deliverables required within the Design Control process.
Responsibilities
- Responsible for ensuring compliance with all federal, state, local, and company regulations, policies, and procedures.
- Provide expertise in the areas of Quality Assurance, Regulatory Compliance, Design Controls, Risk Management, and Statistical Techniques.
- Lead test method development and validation activities for product enhancement programs.
- Assist with driving opportunities internally and with existing suppliers, including support for process (IQ / OQ / PQ) development to ensure robust product design and manufacturing.
- Lead Design Assurance Engineering activities to improve customer satisfaction and successful achievement of corporate and department quality objectives.
- Support investigations for potential product or process failures encountered during the lifecycle of products.
- Ensure Design Assurance Engineering support of customer complaint investigations as required.
- Maintain an up to date knowledge in the areas of Quality Assurance, Regulatory Compliance, Design Controls, Risk Management, and Statistical Techniques including company products, policies, and procedures.
- Lead the development of Risk Management activities and facilitates updates to Risk Management files through regularly scheduled meetings.
- Identifies hazards, mitigates risks associated with hazards, and updates occurrence ratings in FMEAs.
Qualifications
- Excellent verbal and written communication skills
- Working knowledge of GMP / QSR, ISO, EUMDR, and other applicable regulations is expected.
- Working knowledge of desktop computer, office software, and e-mail is required. Knowledge of Minitab statistical software is preferred.
- Ability to handle multiple tasks simultaneously and ability to manage project timelines.
- Detail oriented. Must be accurate in performing statistical techniques and review of documentation containing highly detailed information / data.
Education :
Bachelor’s degree in a scientific discipline or equivalent
Experience :
- Minimum of 5 years experience in the Medical Device Industry.
- Experience with problems of diverse scope in which analysis of data requires evaluation of identifiable factors.
Compensation :
$82,000.00- $130,000.00
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