Kelly Engineering is seeking a cGMP Compliance Engineer to join a leading medical device manufacturing company. This role focuses on ensuring compliance with FDA regulations, ISO 13485 standards, and cGMP requirements. If you are passionate about driving quality and compliance in manufacturing processes and have a track record of success in regulated environments, this opportunity is for you.
Why Join Us?
Innovative Work : Contribute to the development of cutting-edge medical devices.
Career Growth : Opportunity for long-term employment through a contract-to-hire structure.
Competitive Pay : Negotiable rates for exceptional candidates.
Work-Life Balance : Standard weekday schedule with overtime options for flexibility.
Key Responsibilities
Revalidate chemical, electrochemical, laser, and cleaning systems, as well as assembly processes in cleanroom environments.
Lead the validation lifecycle, including risk assessments, deviation investigations, and change control activities.
Author and manage protocols (IQ, OQ, PQ) and summary reports while adhering to cGxP standards.
Identify and mitigate risks proactively to enhance operational efficiency.
Collaborate with cross-functional teams on requirements and project timelines.
Contribute to training and continuous improvement initiatives.
Support investigations, CAPA processes, and quality system audits to ensure compliance.
Qualifications
Education : Bachelor’s degree in engineering or a related science field is required (Master’s preferred).
Experience : Minimum of 5 years in a cGMP manufacturing environment.
Expertise :
ISO 13485 Medical Device standards.
Strong cGxP knowledge, including process validation and qualification.
Experience in pFMEA development and statistical process control (SPC).
Familiarity with ISO Class 7 cleanrooms and equipment qualification.
Skills :
Technical writing for cGxP documentation.
Ability to drive results in regulated environments.
Effective communication and teamwork capabilities.
Ready to make an impact in the medical device industry? Apply now to join a team dedicated to quality and innovation.
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