This position supports quality engineering activities related to validation of equipment, rooms, and other areas including production/automation equipment. Support activities related to manufacturing of product and design control in accordance with FDA and ISO regulations. The ideal candidate will have a Quality Engineering background in a medical Device or pharmaceutical company.
- Support Quality Engineering activities related to equipment and facilities qualifications, production line validations including other tasks as assigned, with focus on Design Control, validation, risk management and continuous process improvement.
- Analyze processes for improvements and evaluate scale-up activities to improve cost-savings, efficiencies and product quality while managing technical and compliance risks.
- Independently prepare validation protocols, support protocol execution and training, analyze test results and prepare protocol reports.
- Work with management to improve Quality System policies and procedures.
- Perform failure investigations for non-conformances, perform root-cause analysis and provide recommendations to management.
- Assist in setting specifications for raw-materials, in-process testing and final product release.
- Assist in internal and external audits.
- B.S. Degree in Engineering, Chemistry, Biology or related field.
- Minimum of 5 years work experience in Quality Engineering or Process Engineering in pharmaceutical or medical device industry with applicable knowledge of cGMP, ISO and FDA regulations.
- Strong knowledge of process validation in reagent assay products and automation production equipment.
- Excellent problem solving and analytical skills.
- Knowledge of applying statistical analysis for SPC, process capability, and design of experiments (knowledge in minitab or related statistical software preferred).
- Effective interpersonal and communication skills in technical writing and capable of supporting cross-functional project teams in microbiology, mechanical engineering, electrical/optical engineering and process engineering disciplines.
- Capable of multitasking and prioritizing several projects independently.
- Experience in cGMP documentation practices and audits
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