Mechanical Engineer

Description:
Participate in all elements of the supplier Quality control system and review DHF/ Core documents from a quality perspective for new product development. Help execute within a QA system and team that ensures alignment to the QMS while optimizing time to regulatory approval/clearance. Work with suppliers to review and drive the following working documents to ensure regulatory clearance and production readiness: engineering drawing review, capability studies, gage RRs, special process validations, CMM correlation studies, PFMEAs, Process flows, control plans, inspection plans, DHR reviews, routers, certifications, Manufacturing materials. Performs Quality System Audits of Suppliers and ensures compliance with FDA QSR and ISO13485 requirements, and internal procedures. Develop and implement corrective/preventative action plans, internal CAPA's and supplier SCARs Provide verification and validation, sampling, and statistical analysis support for all functions required for product clearance/approval through supplier relationships (eg mechanical testing, manufacturing special processes, packaging, sterilization). Design and implement inspection methods, equipment, acceptance criteria and sampling plans to support qualified vendors. Participated in Cadaver labs for Design freeze in new product development projects. Will work on multiple, complex and demanding projects and requires frequent domestic travel. Qualifications: MS in Mechanical Engineering with 1 year of experience or BS in Mechanical Engineering with 6 years of experience in Quality control and Audit of client Quality management and documentation to ensure compliance with FDA QSR and ISO 13485 requirements and defining and managing preventive actions plans for internal CAPA and Supplier SCAR and experience in CMM, PFMA, and DHR reviews and validation. Acceptable alternate experience includes Quality Engineer, Validation Engineer, and Process Engineer and relevant experience that equips the candidate to perform the core duties of this highly senior-level and demanding job Acceptable alternate experience includes Quality Engineer, Validation Engineer, and Process Engineer and relevant experience that equips the candidate to perform the core duties of this highly senior.

Experience in Quality control and Audit of client Quality management and documentation to ensure compliance with FDA QSR and ISO 13485 requirements as well as with internal client specific quality management process, defining and managing preventive action plans for internal CAPA and Supplier SCAR and experience in CMM, PFMA and DHR reviews and validation. Will work on multiple, complex and demanding projects and requires frequent domestic travel