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Sr. Quality Engineer

Company: Kelly Services
Location: Attleboro
Posted on: November 21, 2022

Job Description:

Sr. Quality Engineer (Attleboro MA) Our client, a leading medical contract manufacturer, is currently hiring a Sr. Quality Engineer to assist with identification of best practices for the organization, and demonstrate exceptional compliance to FDA 21, CFR 820 and ISO 13485. Essential Job Duties: Work closely with engineering regarding quality support for new and ongoing projects enabling rapid assimilation of customer specifications into manufacture-able product. Work as part of a team providing CAPA leadership, maintaining improving company policies, procedures work standards, and manufacturing environments. Assist with the design and compilation of metrics for operation's performance, post market surveillance and quality systems data. Support initiatives to analyze and resolve issues which prevent desired quality level achievement. Own and lead critical efforts to reduce rejections. Develop programs for maintenance, replacement and improvement of inspection techniques, gage R and R and new electronic collection and data reduction techniques. Manage and support the environmental monitoring and controls. Manage customer related quality and regulatory inquiries. Coordinate CAPA and NCMR (non-conforming material) meetings and investigate root causes in collaboration with the Auditors, Manufacturing Supervisors and Engineers. Develop plans for implementing corrective actions as necessary. Direct improvements in Quality Assurance processes such as NCMR/MRB. Identify process problems and nonconformance's in manufacturing processes and relay this information to Operations and Manufacturing Engineering. Take part in the troubleshooting process by collaborating with the Manufacturing Engineering and Operations team to develop corrective actions. Support the Quality Assurance organization by collaborating on customer complaints to investigate root causes and implement corrective actions. Respond to customers with written responses to complaints. Perform internal and external audits as required, including pre-audit preparation and assisting with post audit communication. Review procedures for accuracy and make updates using a Document Change Order to reflect process changes. Work with Engineering, Quality Assurance and Operations to develop production procedures, standard operating procedures and drawings. Implement GMP (Good Manufacturing Practices) throughout the manufacturing organization. Coordinate the training of Manufacturing Supervisors and Assemblers and act as a mentor and technical resource. Identify Quality System training or retraining needs and develop and deliver appropriate training based on organizational priorities and training needs. Develop tools to evaluate training effectiveness as appropriate. Participate on New Product Development teams to establish quality standards for new products and create process procedures, specifications and work instructions as needed. Support new product launches by supporting the installation and qualification of new processes and equipment by reviewing protocols, creating sampling plans and approving the protocols and reports confirming accuracy and completeness. Mentor Quality staff and multiple discipline teams in problem solving and root cause techniques. Qualifications: BS/BA in Engineering, Quality or Manufacturing. Minimum 7+ years in Medical Device manufacturing environment. Preferred: Experience with FDA 21 CFR 820 and ISO 13485. Risk Management skills with practical experience (e.g. FMEA and ISO 14871). Strong analytical and problem-solving skills. Ability to make informed decisions with minimal supervision and considers personal safety, the safety of others and product integrity as part of the decision-making process. Project planning. Excellent written and verbal skills. Ability to foster an environment of open and clear communication through effective listening. #TJP2022_SPEC

Keywords: Kelly Services, Attleboro , Sr. Quality Engineer, Engineering , Attleboro, Massachusetts

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