PURPOSE OF JOB Responsible for establishing and improving quality assurance practices and procedures; evaluation of quality sampling plans and inspection methods and reviews/recommends solutions to quality problems.Additionally, this position is responsible to Develop, implement, maintain and improve appropriate quality system elements to ensure the high-quality level of existing products and as well new products transferred to the Site RESPONSIBILITIES Support process, product and/or equipment validation transfers, and design process activities (e.g., IQ, OQ, PQ, etc.).Execute equipment and process validation activities as required.Review and ensure validation protocols as well as monitor quality policies regarding the transfer and validation processes of processes/products.Review process changes, resolve product quality issues, and support implementation or transfers of new products by reviewing quality, testing plans, and quality transfer strategies. Travel and carry out evaluations of new products at the level of product quality risks as well as the transfer and validation strategy.Investigate instances of nonconforming material and facilitate the determination of root cause, correction action/preventive action (internal &supplier), and recommendation of disposition (Material Review Board).Establish and maintain appropriate documentation as required for quality assurance activities Utilizes DMAIC tools to promote a disciplined non-conformance investigation approach and participates in corrective and preventive actions (CAPA)related activities, including CAPA ownership if appropriate.Design means for measuring accuracy and documenting of inspection work Evaluate and recommend inspection gauges and test equipment Evaluate incoming raw material acceptance plans for effectiveness and validity Participate with manufacturing to recommend in-process and final inspection strategies to assure product quality at each stage of manufacturing.Ensure appropriate use of sampling plans and evaluate statistical rationale of acceptance plans at all stages of design and manufacturing Audit processes, internal and supplier, for quality and regulatory compliance and recommends improvements based on analysis of data and system performance Collaborate with suppliers to ensure the quality of incoming materials and components Develop key indices of measurements for quality, cost and delivery and improve cycle times Analyze routine and test data for improvement opportunities Ensure compliance with industry regulations and quality standards Provide technical guidance and training to other team members in statistical analysis techniques, experimental design, data analysis, sampling techniques and other QA engineering areas (once he obtains Minitab training and ASQ certification).REQUIREMENTS EDUCATION : Bachelor's Degree in Mechanical Engineering, Chemical Engineering, Industrial Engineering, Electromechanical Engineering or a related field EXPERIENCE : Minimum 4 years of experience as an engineer within a medical device manufacturing environment (required).Minimum 2 years of experience in process validation (required).Proven previous experience with IQ, OQ, PQ and previous working knowledge of the quality system regulation (21CFR PART 820) and ISO 13485 requirements (required).Proven previous experience working with Minitab (required).PREFERRED QUALIFICATIONS : Knowledge/previous working experience with ASQ CQE/CSSBB is considered a plus.POSITION SKILLS : Strong written and verbal communication skills.Able to work effectively in a team.Excellent organizational skills.Familiar with projects management.Powered by JazzHR
