Description
Job Opportunity:in need of a knowledgeable and experienced Quality Assurance Engineer to play a key role in managing the selection, qualification, calibration, maintenance and validation of laboratory equipment, and in maintaining accurate and complete documentation of these activities in compliance with the requirements of the Quality System Regulation (21 CFR 820) and ISO 13485.
The candidate should have:
- Hands-on experience working with state-of-the-art laboratory equipment
- Experience writing and executing laboratory Work Instructions, protocols, and procedures
- Experience writing, executing, and documenting equipment IQ/OQ/PQ validations
- A technical understanding of laboratory equipment sufficient to allow preparation of detailed qualification, operation, maintenance and calibration procedures for laboratory personnel to follow
- Experience with risk assessment/analysis processes
Excellent writing skills, verbal communication, and organizational skills are critical.
Role and Responsibilities: Under the direction of the Manager, Quality Assurance:
- Assist scientific staff in identifying and documenting requirements for new instruments and selecting equipment that meets requirements.
- Prepare protocols for installation, operational and performance qualification of instruments, direct the execution of these protocols and write the final reports.
- Write Quality System procedures for instrument operation, routine maintenance and calibration.
- Plan and schedule instrument maintenance and calibration performed by external vendors.
- Manage the environmental monitoring system, and coordinate responses and corrective actions to alarms and out-of-specification conditions.
- Respond to equipment malfunctions and coordinate repairs performed by external vendors.
Maintain detailed records of equipment purchase, qualification, calibration, repair and maintenance in compliance with documented Quality System Procedures
Education, Certification/Licensing and Experience:
Required:
- Bachelor Degree is required in a technical discipline in the sciences, life sciences, or engineering.
- Knowledge of the requirements of the FDA Quality System Regulation and ISO 13485.
- Five or more years of relevant experience in an FDA regulated industry, with 3-5 years' experience in Quality Assurance.
- Experience with equipment installation, operational and performance (IQ/OQ/PQ) qualification.
Highly Desired:
- ASQ Certification as Quality Engineer (CQE) or equivalent.
- Experience in writing requirements documents, IQ/OQ/PQ protocols and qualification reports.