LanceSoft Inc
Overview
Join our dynamic team in Billerica, MA, where you will play a crucial role in ensuring the quality and compliance of our medical device manufacturing processes. We are seeking a dedicated professional with a strong background in quality management within the medical device industry. Responsibilities
Partner with Manufacturing Engineering and Supervisors to assess and determine routes for non-conformances. Conduct quality line walks to ensure compliance and audit readiness. Own and collaborate on Quality Management System (QMS) and Process change orders. Represent Quality in process improvement projects. Collaborate with cross-functional teams to resolve quality issues. Ensure corrective actions and documentation meet regulatory and internal standards. Qualifications
3 years of experience in the medical device industry, with a strong background in Non-Conforming Materials Reports (NCMR), CAPA, or product quality management. Solid understanding of FDA regulations (21 CFR Part 820), ISO 13485, EU MDR, and other relevant medical device regulations. Proven experience leading NCMR and CAPA processes, ideally within a medical device or regulated industry. Strong project management skills, with the ability to manage multiple priorities and deadlines. Excellent problem-solving and analytical skills, with the ability to identify root causes and implement effective corrective actions. Outstanding communication and interpersonal skills, capable of effectively working with cross-functional teams and external stakeholders. Proficiency in Microsoft Office Suite and quality management systems (QMS). Strong technical writing capability. Experience in Process Validation. Experience working in a clean room or regulated manufacturing environment. Nice to Have
Familiarity with scientific problem-solving methodologies such as DMAIC, process mapping, 5 Whys, Is/Is Not analysis. Experience with Agile Map change control systems. Familiarity with SAP ERP manufacturing systems and electronic manufacturing execution systems (MES). Top Technical Skills
Experience working in a clean room or regulated manufacturing environment. 3 years of experience in the medical device industry, with a strong background in Non-Conforming Materials Reports (NCMR), CAPA, or product quality management. Excellent problem-solving and analytical skills, with the ability to identify root causes and implement effective corrective actions. Education and Experience
Requires a University Degree and minimum of 2 years of relevant experience, or an advanced degree with 0 years of experience. Work Schedule
This position is 100% on-site, working 40 hours per week. You will support the 1st shift in Disposables Manufacturing. Location
Billerica, MA Closing
Join us in Billerica, MA, and contribute to the development of high-quality medical devices that make a difference in people’s lives.
#J-18808-Ljbffr
Join our dynamic team in Billerica, MA, where you will play a crucial role in ensuring the quality and compliance of our medical device manufacturing processes. We are seeking a dedicated professional with a strong background in quality management within the medical device industry. Responsibilities
Partner with Manufacturing Engineering and Supervisors to assess and determine routes for non-conformances. Conduct quality line walks to ensure compliance and audit readiness. Own and collaborate on Quality Management System (QMS) and Process change orders. Represent Quality in process improvement projects. Collaborate with cross-functional teams to resolve quality issues. Ensure corrective actions and documentation meet regulatory and internal standards. Qualifications
3 years of experience in the medical device industry, with a strong background in Non-Conforming Materials Reports (NCMR), CAPA, or product quality management. Solid understanding of FDA regulations (21 CFR Part 820), ISO 13485, EU MDR, and other relevant medical device regulations. Proven experience leading NCMR and CAPA processes, ideally within a medical device or regulated industry. Strong project management skills, with the ability to manage multiple priorities and deadlines. Excellent problem-solving and analytical skills, with the ability to identify root causes and implement effective corrective actions. Outstanding communication and interpersonal skills, capable of effectively working with cross-functional teams and external stakeholders. Proficiency in Microsoft Office Suite and quality management systems (QMS). Strong technical writing capability. Experience in Process Validation. Experience working in a clean room or regulated manufacturing environment. Nice to Have
Familiarity with scientific problem-solving methodologies such as DMAIC, process mapping, 5 Whys, Is/Is Not analysis. Experience with Agile Map change control systems. Familiarity with SAP ERP manufacturing systems and electronic manufacturing execution systems (MES). Top Technical Skills
Experience working in a clean room or regulated manufacturing environment. 3 years of experience in the medical device industry, with a strong background in Non-Conforming Materials Reports (NCMR), CAPA, or product quality management. Excellent problem-solving and analytical skills, with the ability to identify root causes and implement effective corrective actions. Education and Experience
Requires a University Degree and minimum of 2 years of relevant experience, or an advanced degree with 0 years of experience. Work Schedule
This position is 100% on-site, working 40 hours per week. You will support the 1st shift in Disposables Manufacturing. Location
Billerica, MA Closing
Join us in Billerica, MA, and contribute to the development of high-quality medical devices that make a difference in people’s lives.
#J-18808-Ljbffr