Quality Engineer

Description Kelly Engineering Resources is currently looking for a Direct Hire Senior Biomedical Quality Engineer for a great company in Pittsburgh, Pennsylvania. The Senior Quality Engineer will work closely with internal and external resources utilizing various Quality Engineering tools in the development and manufacture of a polymeric surgical adhesive currently in clinical trials, as well as maintenance and support of innovative new products, materials and processes. This individual will function as a quality lead on multi-functional product development and manufacturing teams in matters relating to Quality Engineering. Responsibilities will include implementation of FDA Design Control requirements for medical devices through design verification, validation and commercial launch. Candidate will manage design control processes, validation activities, material sourcing and vendor management for new and existing products. This individual will ensure effective and efficient use of Quality Engineering techniques such as risk analysis, test method development, statistical data analysis, and the development of sample plans. The Senior Quality Engineer will implement effective and comprehensive quality strategies for development and validation, and will establish appropriate test methods for design and manufacture of products and components. The Senior Quality Engineer will assist in thorough investigation of quality issues and effective corrective and/or preventive action, and will provide guidance to project teams, suppliers and other disciplines to ensure compliance with company policies and procedures as well as applicable medical device regulations.
Experience/Skills
' 5+ years experience in product development for Class III medical devices, preferably polymer biomaterials, from pre-clinical phase through commercialization ' engineering level understanding of the development and regulatory challenges for liquid polymer devices ' management of FDA Design Control documentation through design verification, validation, and commercial launch phases ' extensive knowledge of FDA and ISO regulations for medical devices for both US and European markets
Qualifications A minimum of a Bachelor's degree in Engineering, Life Science, Physical Science or a related field is required, with an advanced chemistry/chemical engineering degree preferred. A minimum of 5+ years of Quality Engineering experience is required. Experience in the medical device, pharmaceutical or other highly regulated industry is required. New product development experience with Class III medical devices is required. Experience with the development of liquid polymeric devices is considered a strong asset. Knowledge of ISO and/or cGMP regulations is required. Strong knowledge in Quality Systems Regulations (QSR) preferred. ASQ certifications (CQE, CQM, CRE or CQA) is preferred. Knowledge in Statistics, Sampling Planning, Reliability, Design Validation and Process Validation and strong supplier management skill set is an asset. Supplier quality engineering experience is a plus. Candidate must be able to communicate effectively at all levels of the organization. This position may require up to 20% travel. If interested in this great opportunity, please submit your resume for immediate consideration.

Requirements ' 5+ years experience in product development for Class III medical devices, preferably polymer biomaterials, from pre-clinical phase through commercialization ' engineering level understanding of the development and regulatory challenges for liquid polymer devices ' management of FDA Design Control documentation through design verification, validation, and commercial launch phases ' extensive knowledge of FDA and ISO regulations for medical devices for both US and European markets. A minimum of a Bachelor's degree in Engineering, Life Science, Physical Science or a related field is required, with an advanced chemistry/chemical engineering degree preferred. A minimum of 5+ years of Quality Engineering experience is required. Experience in the medical device, pharmaceutical or other highly regulated industry is required. New product development experience with Class III medical devices is required. Experience with the development of liquid polymeric devices is considered a strong asset