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