Test Equipment Specialist
We are seeking a skilled Test Equipment Specialist to join our team in a GMP-regulated manufacturing company. The successful candidate will be responsible for planning and implementing test equipment qualification and test method validation.
This role involves ensuring that products are tested in compliance with regulations, including statistical sampling plans and test procedures. Additionally, the Test Equipment Specialist will provide necessary training to chapter members and stakeholders on test procedures.
* Key Responsibilities:
* Design and develop test equipment and fixtures
* Define acceptance criteria for test equipment
* Collaborate with cross-functional teams to ensure regulatory compliance
* Conduct training sessions for internal and external stakeholders
* Perform technical documentation reviews
Requirements:
* Bachelor's degree in Engineering, Natural Science or related field
* 3+ years of experience in a GMP-regulated manufacturing company
* Knowledge of ISO 13485 and FDA 21 CFR part 820
* Excellent communication and analytical skills