My client is a medical device developer located in beautiful Bucks County, PA. We are pioneering innovative, next-generation treatment devices for personal health monitoring.
You will collaborate with Process and Quality Engineers to draft and execute process validation protocols (IQ, OQ, PQ) and document their results. Your efforts will demonstrate processes are running according to specifications, within applicable regulations and to ensure data integrity and the production of quality products.
This is a full-time, on-site position.
Responsibilities:
Participates in teams assembled to specify, install, validate, troubleshoot, and maintain systems and equipment.
Executes equipment and process validation studies (IQ, OQ,PQ) to include protocol preparation, scheduling, execution, including data analysis and generation of summary reports.
Execute gage R&R and test method of QC test and inspection methods.
Ensure integration of validation schedule in the production schedule for implementation of validation activities and ensure due dates and customer needs are met.
Ensure compliance with company's SOPs and Quality Standards for validation and qualification activities.
Assess the potential impact of changes to qualified systems; Identify and implement validation best practices to continuously improve the site validation program.
Participates in deviation investigations to identify root causes and define corrective and/or preventative actions (CAPA).
Support regulatory audits through the preparation, defense, and interaction with auditors in areas related to sterilization, commodity prep, and formulation equipment.
May mentor junior-level engineers.
Contribute to the completion of complex projects, manage own time to meet agreed targets, and develop plans for work activities on own projects in collaboration with a team.
Qualifications:
Bachelor's Degree in a related discipline (e.g. Engineering, Physical or Life Science) with an advanced degree preferred.
Minimum 5 years experience in medical device quality or process engineering that includes direct experience planning, writing, and executing process validations
Demonstrated success in executing process validations in a medical device manufacturing environment.
Knowledge of FDA medical device regulations and international standards for medical devices.
Certified Quality Engineer (CQE) certification is a plus.