Katalyst Healthcares and Life Sciences
Responsibilities:
The Quality Engineer is the Quality point of contact for strategic customers, for customer driven actions & requests, and Quality Engineering support. Conduct and complete Product Verification Reports (PVR) (i.e. customer PPAPs) for new production introduction (NPI) and customer engineering changes. Investigate product complaints and reported quality issues through PDCA and 8D to ensure closure in accordance with company guidelines and external regulatory requirements and customer expectations. Maintain Corrective and Preventative Action (CPAR) process to ensure Root Cause Analysis (RCA) and identified solution is in place and effective for internal, external, and regulatory reported findings. Monitor and ensure Supplier Corrective Action Reports (SCAR) are effective and resolved in a timely manner. Use and create problem logs to identify and report recurring issues to management and product development teams to drive continuous improvement. Facility customer quality action list to collect, analyze, and summarize data leading to continuous improvement of Company and Customer quality. Implement methods to inspect, test and evaluate the reliability of product quality. Collaborate with Department Managers to maintain, create, & revise QMS documentation as necessary to maintain ISO 9001 registration. Working in accordance with deadlines and priorities for delivery and customer driven actions to required dates. Conduct Internal Audits to ISO 9001:2015 standards. Complete and support customer compliance requests for regulatory compliance (i.e. Rohs & REACH). Participate in MRB meetings and product dispositions. ssist Quality Management in tracking, documenting, and reporting quality levels to meet Quality, CSR (corporate social responsibility), environmental, and health and safety goals/KPIs. Provide cross-functional Quality Engineering support for all I Automation facilities as needed. Requirements:
Requires a bachelor's degree in engineering (i.e. mechanical, chemical, or industrial). 5+ years of professional experience in Quality Engineering. Strong understanding of ISO 9001 standard requirements. Corrective and Preventative Action (CPAR). Root Cause Analysis and 8D. QMS documentation. Investigate product complaints. Product Verification Reports (PVR). Internal Audits to ISO 9001:2015 standards.
The Quality Engineer is the Quality point of contact for strategic customers, for customer driven actions & requests, and Quality Engineering support. Conduct and complete Product Verification Reports (PVR) (i.e. customer PPAPs) for new production introduction (NPI) and customer engineering changes. Investigate product complaints and reported quality issues through PDCA and 8D to ensure closure in accordance with company guidelines and external regulatory requirements and customer expectations. Maintain Corrective and Preventative Action (CPAR) process to ensure Root Cause Analysis (RCA) and identified solution is in place and effective for internal, external, and regulatory reported findings. Monitor and ensure Supplier Corrective Action Reports (SCAR) are effective and resolved in a timely manner. Use and create problem logs to identify and report recurring issues to management and product development teams to drive continuous improvement. Facility customer quality action list to collect, analyze, and summarize data leading to continuous improvement of Company and Customer quality. Implement methods to inspect, test and evaluate the reliability of product quality. Collaborate with Department Managers to maintain, create, & revise QMS documentation as necessary to maintain ISO 9001 registration. Working in accordance with deadlines and priorities for delivery and customer driven actions to required dates. Conduct Internal Audits to ISO 9001:2015 standards. Complete and support customer compliance requests for regulatory compliance (i.e. Rohs & REACH). Participate in MRB meetings and product dispositions. ssist Quality Management in tracking, documenting, and reporting quality levels to meet Quality, CSR (corporate social responsibility), environmental, and health and safety goals/KPIs. Provide cross-functional Quality Engineering support for all I Automation facilities as needed. Requirements:
Requires a bachelor's degree in engineering (i.e. mechanical, chemical, or industrial). 5+ years of professional experience in Quality Engineering. Strong understanding of ISO 9001 standard requirements. Corrective and Preventative Action (CPAR). Root Cause Analysis and 8D. QMS documentation. Investigate product complaints. Product Verification Reports (PVR). Internal Audits to ISO 9001:2015 standards.