Integrated Resources, Inc ( IRI )
Supplier Quality Engineer
Integrated Resources, Inc ( IRI ), Marlborough, Massachusetts, us, 01752
Overview
Title:
Supplier Quality Engineer Location:
Marlborough, MA Duration:
11 Months Shift & Timing:
Regular Business Hours, Monday to Friday Pay Range:
Up to $55/Hour Responsibilities
This position provides support to the Global Supplier Quality organization dedicated to the oversight of components, other materials & services. He/she will provide technical knowledge across the organization to ensure suppliers can meet all requirements. Execute all applicable activities to comply with regulatory standards and meet the requirements established in the Quality Management System around supplier’s quality management. Conduct technical reviews of suppliers to understand their capability to make materials. Oversee, assess, and monitor suppliers making parts as it relates to manufacturing, process and quality control practices, corrective action, continuous improvement, and “First Article Inspection”. Define and approve PPAP (Production Part Approval Process) requirements for all new and revised purchased parts (as applicable). Follow up for their on-time completion. Work with suppliers to exceed the “fit, form and function” and reliability requirements, while collaborating with Research & Development and Design Assurance. Issue and follow up on Agile Quality figures called “SCARs” and “SACAs” and “NCEs” related to suppliers. Monitor timing of the workflows to comply with key performance indicators established. Collaborate with suppliers on problem solving and root cause analysis to avoid repeat failures. Apply metrology and statistical measurement to problem analysis and resolution where applicable. Coordinate with Post Market Surveillance and other departments (Quality Engineering, MFG Engineering, R&D) to address complaints linked to supplier situations. Resolve day-to-day quality issues with suppliers worldwide by addressing non-conformities and coordinating with relevant departments to disposition impacted material (return to supplier, rework, sort, etc.). When needed, collect and send back samples to suppliers. As a PPAP-certified part number, work with Incoming Quality to include suppliers in the “Skip Lot Program” (as applicable) or remove suppliers if poor quality is detected. Maintain complete supplier quality records per applicable procedures (e.g., supplier performance indicators, supplier quality certifications, etc.). Update suppliers’ files when required and ensure information is accurate and complete, fulfilling applicable regulatory standards. Support audits as a subject matter expert. Travel may be required, domestically and internationally. Update the ERP system with the status of approved suppliers for the different materials (as applicable). Qualifications / Skills
Communication—ability to communicate effectively in written and verbal form at all levels of the organization. Ability to use problem-solving tools (SPC, TQM, etc.) to optimize processes. Ability to analyze situations or data and translate information into meaningful proposals or action plans. High proficiency with Microsoft Office to produce reports and analyze data. Ability to manage multiple complex projects. Knowledge of project management techniques. Working knowledge of Medical Device Regulations/In Vitro Diagnostic Regulation (as applicable), cGMP, CFR 820, ISO-13485, ISO-14971, ISO-9001. Ability to work independently and with all levels of the organization. ISO 13485 leader auditor (Desirable). Quality System Regulation; Validations (IQ, OQ, PQ) and CAPA (root cause analysis). Statistical Process Controls (SPC) and statistical sampling know-how. Experience
Minimum 2 years of professional experience, with a Bachelor’s degree, in roles of a similar nature in the medical industry, interacting with the quality management system. Full clean driver’s license (desirable). Proficiency in written and spoken English. A second language is a plus. Microsoft Office Internet Email
#J-18808-Ljbffr
Title:
Supplier Quality Engineer Location:
Marlborough, MA Duration:
11 Months Shift & Timing:
Regular Business Hours, Monday to Friday Pay Range:
Up to $55/Hour Responsibilities
This position provides support to the Global Supplier Quality organization dedicated to the oversight of components, other materials & services. He/she will provide technical knowledge across the organization to ensure suppliers can meet all requirements. Execute all applicable activities to comply with regulatory standards and meet the requirements established in the Quality Management System around supplier’s quality management. Conduct technical reviews of suppliers to understand their capability to make materials. Oversee, assess, and monitor suppliers making parts as it relates to manufacturing, process and quality control practices, corrective action, continuous improvement, and “First Article Inspection”. Define and approve PPAP (Production Part Approval Process) requirements for all new and revised purchased parts (as applicable). Follow up for their on-time completion. Work with suppliers to exceed the “fit, form and function” and reliability requirements, while collaborating with Research & Development and Design Assurance. Issue and follow up on Agile Quality figures called “SCARs” and “SACAs” and “NCEs” related to suppliers. Monitor timing of the workflows to comply with key performance indicators established. Collaborate with suppliers on problem solving and root cause analysis to avoid repeat failures. Apply metrology and statistical measurement to problem analysis and resolution where applicable. Coordinate with Post Market Surveillance and other departments (Quality Engineering, MFG Engineering, R&D) to address complaints linked to supplier situations. Resolve day-to-day quality issues with suppliers worldwide by addressing non-conformities and coordinating with relevant departments to disposition impacted material (return to supplier, rework, sort, etc.). When needed, collect and send back samples to suppliers. As a PPAP-certified part number, work with Incoming Quality to include suppliers in the “Skip Lot Program” (as applicable) or remove suppliers if poor quality is detected. Maintain complete supplier quality records per applicable procedures (e.g., supplier performance indicators, supplier quality certifications, etc.). Update suppliers’ files when required and ensure information is accurate and complete, fulfilling applicable regulatory standards. Support audits as a subject matter expert. Travel may be required, domestically and internationally. Update the ERP system with the status of approved suppliers for the different materials (as applicable). Qualifications / Skills
Communication—ability to communicate effectively in written and verbal form at all levels of the organization. Ability to use problem-solving tools (SPC, TQM, etc.) to optimize processes. Ability to analyze situations or data and translate information into meaningful proposals or action plans. High proficiency with Microsoft Office to produce reports and analyze data. Ability to manage multiple complex projects. Knowledge of project management techniques. Working knowledge of Medical Device Regulations/In Vitro Diagnostic Regulation (as applicable), cGMP, CFR 820, ISO-13485, ISO-14971, ISO-9001. Ability to work independently and with all levels of the organization. ISO 13485 leader auditor (Desirable). Quality System Regulation; Validations (IQ, OQ, PQ) and CAPA (root cause analysis). Statistical Process Controls (SPC) and statistical sampling know-how. Experience
Minimum 2 years of professional experience, with a Bachelor’s degree, in roles of a similar nature in the medical industry, interacting with the quality management system. Full clean driver’s license (desirable). Proficiency in written and spoken English. A second language is a plus. Microsoft Office Internet Email
#J-18808-Ljbffr