TalentCraft
Senior Quality Engineer (Supplier Development)
TalentCraft, Burlington, Massachusetts, us, 01805
Senior Quality Engineer (Supplier Development)
Quality Engineer has the primary responsibility of supporting the supplier development and manufacturing of components and parts for Class I, II and III medical devices. Commodities will include electronics, molding, electro-mechanical, as well as mechanical industries. Responsibilities: Supplier Development and Parts Qualification: Support Quality Engineering, R&D and commercial engineering in the evaluation of new suppliers and components. Support the engineering teams to assess technical and manufacturing capabilities of prospective suppliers and define necessary technical requirements, tests and documentation for sourced products. Provide the product development teams with SME knowledge of manufacturing processes, such as PCBA manufacturing, OEM electro-mechanical assembly, machining/metal forming and plastics molding. Support execution of supplier qualifications including evaluation of supplier product realization processes to ensure suppliers can produce components that consistently meet pre-determined specifications. Support MSA at supplier and work with Quality Engineers and Design/Manufacturing Engineering to ensure continuity of Product and Process Quality Control Plans with Receiving Inspection. Investigate and disposition identified supplier related nonconforming components. Evaluate supplier changes requests and coordinate review with internal staff. Collaborate with suppliers on internal specification changes. Ensures the supplier development and parts qualification process aligns with the Supplier Quality program. Review the Approved Supplier List to ensure ASL data accuracy. Supports Supplier Quality Engineering on routine supplier technical assessments/process assessments based on performance data. Support the issuance and closure of Supplier Corrective Action Requests (SCAR) and Supplier Notification (SN) process. Review documentation to support changes at suppliers. Work with suppliers to resolve quality issues. Other Duties as Assigned. Additional other duties and projects as required to facilitate R&D, Operations, Production, Engineering, Clinical and Regulatory goals and objectives. Education/Experience: Bachelors degree in Engineering (Mechanical, Electrical, Industrial preferred) with 5+ years work experience in a production or engineering environment required. Masters degree with 3+ years work experience. 3+ years in Medical Device or other semi-regulated industries required. Aptitude towards most and mastery of some of the general knowledge, skills and abilities listed below. General Knowledge, Skills, and Abilities: Technical process knowledge of plastics/polymer molding, alloy machining and forming, and electronics/electromechanical assembly. Product/process validation experience Strong knowledge of medical device manufacturing. Knowledge of Process Capability and data analysis using statistical tools Working understanding of 21 CFR Part 820 and ISO 13485 and 14971 requirements Knowledge of FDA process validation Excellent documentation skills, attention to detail and accuracy Must be organized and able to coordinate activities with internal departments and outside suppliers. Strength is working well in a team environment while continually and constructively challenging the status quo. Seniority level
Associate Employment type
Contract Job function
Engineering, Science, and Quality Assurance Industries
Medical Equipment Manufacturing, Biotechnology Research, and Pharmaceutical Manufacturing
#J-18808-Ljbffr
Quality Engineer has the primary responsibility of supporting the supplier development and manufacturing of components and parts for Class I, II and III medical devices. Commodities will include electronics, molding, electro-mechanical, as well as mechanical industries. Responsibilities: Supplier Development and Parts Qualification: Support Quality Engineering, R&D and commercial engineering in the evaluation of new suppliers and components. Support the engineering teams to assess technical and manufacturing capabilities of prospective suppliers and define necessary technical requirements, tests and documentation for sourced products. Provide the product development teams with SME knowledge of manufacturing processes, such as PCBA manufacturing, OEM electro-mechanical assembly, machining/metal forming and plastics molding. Support execution of supplier qualifications including evaluation of supplier product realization processes to ensure suppliers can produce components that consistently meet pre-determined specifications. Support MSA at supplier and work with Quality Engineers and Design/Manufacturing Engineering to ensure continuity of Product and Process Quality Control Plans with Receiving Inspection. Investigate and disposition identified supplier related nonconforming components. Evaluate supplier changes requests and coordinate review with internal staff. Collaborate with suppliers on internal specification changes. Ensures the supplier development and parts qualification process aligns with the Supplier Quality program. Review the Approved Supplier List to ensure ASL data accuracy. Supports Supplier Quality Engineering on routine supplier technical assessments/process assessments based on performance data. Support the issuance and closure of Supplier Corrective Action Requests (SCAR) and Supplier Notification (SN) process. Review documentation to support changes at suppliers. Work with suppliers to resolve quality issues. Other Duties as Assigned. Additional other duties and projects as required to facilitate R&D, Operations, Production, Engineering, Clinical and Regulatory goals and objectives. Education/Experience: Bachelors degree in Engineering (Mechanical, Electrical, Industrial preferred) with 5+ years work experience in a production or engineering environment required. Masters degree with 3+ years work experience. 3+ years in Medical Device or other semi-regulated industries required. Aptitude towards most and mastery of some of the general knowledge, skills and abilities listed below. General Knowledge, Skills, and Abilities: Technical process knowledge of plastics/polymer molding, alloy machining and forming, and electronics/electromechanical assembly. Product/process validation experience Strong knowledge of medical device manufacturing. Knowledge of Process Capability and data analysis using statistical tools Working understanding of 21 CFR Part 820 and ISO 13485 and 14971 requirements Knowledge of FDA process validation Excellent documentation skills, attention to detail and accuracy Must be organized and able to coordinate activities with internal departments and outside suppliers. Strength is working well in a team environment while continually and constructively challenging the status quo. Seniority level
Associate Employment type
Contract Job function
Engineering, Science, and Quality Assurance Industries
Medical Equipment Manufacturing, Biotechnology Research, and Pharmaceutical Manufacturing
#J-18808-Ljbffr