Smtnet
Corporate Director of Quality
Smtnet, Williamsport, Pennsylvania, us, 17705
Corporate Director of Quality - Works on site in Williamsport, PAReports to VP of OperationsSummary
The Quality Director is responsible for assuring the program health and operation of the overall quality management systems and the Quality Assurance functional organizations for Spartronics. The Quality Director has overall leadership responsibility for all quality-related aspects of customer requirements, design, supply base, manufacturing, test, service, etc. through the appropriate application of Quality Engineering, Supplier Quality, Quality Assurance, Quality Control, and Continuous Improvement processes for the business. The Quality Director works with the segment and site Quality Leaders and stakeholders throughout the company to continuously improve processes and capabilities, while assuring cost-effective compliance to internal, customer, and regulatory requirements. The Quality Director continuously plans, measures, prioritizes, improves, and works to remove constraints to balance customer advocacy with Spartronics business success.Responsibilities
Promote and assure a safe and respectful team-based working environment.Partner with all stakeholders and functional organizations to assure timely and effective communications, reporting, and customer support.Assure an escalation path and resolution for quality-related issues and customer concerns.Lead, harmonize, and continuously improve all aspects of the business’s quality management systems, quality assurance organizations, and continuous improvement programs to provide additional value back to the business.Implement automated and information technology systems (e.g., ERP, PLM, MES) that facilitate improvements to quality management systems and processes, while maintaining compliance with regulatory and customer requirements.Interpret customer, regulatory, and internal requirements into program and product specific quality planning and procedures for use in design, purchasing, inventory, manufacturing, test, inspection, and customer service.Assure the overall certification, evaluation, auditing, compliance, and continuous improvement of the Quality Management Systems (QMS) to required industry standards (e.g., AS9100, ISO13485, FDA CFR 820).Identify and drive proactive risk reduction, failure analysis, root cause determination, and permanent corrective action and facilitate continuous process improvements.Work with internal and external customers to efficiently analyze, resolve, and manage quality issues that arise to prevent negative impacts to product quality, service, schedule performance, and/or cost.Assure development and deployment of quality engineering processes (e.g., APQP, FAIR, Validations, PPAP, Control Plans, PFMEA, Inspection Plans, Source Inspection documentation, etc.) in support of business needs.Assure data availability, traceability, and product integrity in support of customer requirements.Consolidate, analyze, and report process and product quality results and issues to management and customers.Other duties as assigned by senior leadership.Requirements and Skills
Strong customer service attitude and proactive approach.Ability to develop and maintain strong working relationships with suppliers, external customers, and internal partners.Excellent analytical and systems application abilities for process and product related data.Ability to utilize a variety of techniques to assess root cause and solve problems.Ability to manage multiple projects and/or issues simultaneously.Ability to lead problem-solving investigations and continuous improvement teams.Excellent presentation and communication skills, both written and oral.Strong experience with MS Office tools (e.g., MS Excel, MS Word, and MS PowerPoint) as well as data extraction and analysis (e.g., SQL, Access, Minitab).Key Metrics and Focus Areas
Effective Quality Management System execution, auditing, and improvement.Proactive Quality Engineering and Supplier Quality processes and customer focus.Effective Continuous Improvement program management and Return on Investment.Effective Root Cause Analysis and Corrective Action program management.Effective and timely Customer Corrective Action Response management.Process data analysis, and effective non-conforming material control and reduction.Scrap / Rework analysis and reductions.Facilitation of Cost of Poor Quality programs and strategic cost reduction opportunities.Return Merchandise Authorization (RMA) program management and customer focus.Requirements
Bachelor’s degree in a STEM field.Master’s degree in business or engineering (preferred).Lean Six Sigma Black Belt certification.10 – 20 years of Quality-discipline related work experience with electronic assemblies.5 – 10 years of management experience, including direct management of people.5+ years of related work experience in the medical, military, or aerospace products sector.FDA 21 CFR 820 compliance, auditor hosting, corrective action, and correspondence.FDA facility and listing registration.Auditor certification with ISO 9001, 13485, and AS9100 Quality Management Systems.MDSAP (Medical Single Audit Program) compliance and implementation.MDR (EU), ANVISA, MHLW, HC, TGA compliance (desired).Root Cause / Corrective Action / Complaint Handling.Process Validation / Risk Analysis.Material Review Board / Nonconforming Material Control.ERP, PLM, and MES systems implementation and compliance.FDA 21 CFR 11 compliance for electronic systems.Ability to travel up to 50% to other manufacturing sites.IPC and J-STD electronic assembly certifications (desired).The ability to obtain and maintain a DoD security clearance (required).Relocation assistance available.
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The Quality Director is responsible for assuring the program health and operation of the overall quality management systems and the Quality Assurance functional organizations for Spartronics. The Quality Director has overall leadership responsibility for all quality-related aspects of customer requirements, design, supply base, manufacturing, test, service, etc. through the appropriate application of Quality Engineering, Supplier Quality, Quality Assurance, Quality Control, and Continuous Improvement processes for the business. The Quality Director works with the segment and site Quality Leaders and stakeholders throughout the company to continuously improve processes and capabilities, while assuring cost-effective compliance to internal, customer, and regulatory requirements. The Quality Director continuously plans, measures, prioritizes, improves, and works to remove constraints to balance customer advocacy with Spartronics business success.Responsibilities
Promote and assure a safe and respectful team-based working environment.Partner with all stakeholders and functional organizations to assure timely and effective communications, reporting, and customer support.Assure an escalation path and resolution for quality-related issues and customer concerns.Lead, harmonize, and continuously improve all aspects of the business’s quality management systems, quality assurance organizations, and continuous improvement programs to provide additional value back to the business.Implement automated and information technology systems (e.g., ERP, PLM, MES) that facilitate improvements to quality management systems and processes, while maintaining compliance with regulatory and customer requirements.Interpret customer, regulatory, and internal requirements into program and product specific quality planning and procedures for use in design, purchasing, inventory, manufacturing, test, inspection, and customer service.Assure the overall certification, evaluation, auditing, compliance, and continuous improvement of the Quality Management Systems (QMS) to required industry standards (e.g., AS9100, ISO13485, FDA CFR 820).Identify and drive proactive risk reduction, failure analysis, root cause determination, and permanent corrective action and facilitate continuous process improvements.Work with internal and external customers to efficiently analyze, resolve, and manage quality issues that arise to prevent negative impacts to product quality, service, schedule performance, and/or cost.Assure development and deployment of quality engineering processes (e.g., APQP, FAIR, Validations, PPAP, Control Plans, PFMEA, Inspection Plans, Source Inspection documentation, etc.) in support of business needs.Assure data availability, traceability, and product integrity in support of customer requirements.Consolidate, analyze, and report process and product quality results and issues to management and customers.Other duties as assigned by senior leadership.Requirements and Skills
Strong customer service attitude and proactive approach.Ability to develop and maintain strong working relationships with suppliers, external customers, and internal partners.Excellent analytical and systems application abilities for process and product related data.Ability to utilize a variety of techniques to assess root cause and solve problems.Ability to manage multiple projects and/or issues simultaneously.Ability to lead problem-solving investigations and continuous improvement teams.Excellent presentation and communication skills, both written and oral.Strong experience with MS Office tools (e.g., MS Excel, MS Word, and MS PowerPoint) as well as data extraction and analysis (e.g., SQL, Access, Minitab).Key Metrics and Focus Areas
Effective Quality Management System execution, auditing, and improvement.Proactive Quality Engineering and Supplier Quality processes and customer focus.Effective Continuous Improvement program management and Return on Investment.Effective Root Cause Analysis and Corrective Action program management.Effective and timely Customer Corrective Action Response management.Process data analysis, and effective non-conforming material control and reduction.Scrap / Rework analysis and reductions.Facilitation of Cost of Poor Quality programs and strategic cost reduction opportunities.Return Merchandise Authorization (RMA) program management and customer focus.Requirements
Bachelor’s degree in a STEM field.Master’s degree in business or engineering (preferred).Lean Six Sigma Black Belt certification.10 – 20 years of Quality-discipline related work experience with electronic assemblies.5 – 10 years of management experience, including direct management of people.5+ years of related work experience in the medical, military, or aerospace products sector.FDA 21 CFR 820 compliance, auditor hosting, corrective action, and correspondence.FDA facility and listing registration.Auditor certification with ISO 9001, 13485, and AS9100 Quality Management Systems.MDSAP (Medical Single Audit Program) compliance and implementation.MDR (EU), ANVISA, MHLW, HC, TGA compliance (desired).Root Cause / Corrective Action / Complaint Handling.Process Validation / Risk Analysis.Material Review Board / Nonconforming Material Control.ERP, PLM, and MES systems implementation and compliance.FDA 21 CFR 11 compliance for electronic systems.Ability to travel up to 50% to other manufacturing sites.IPC and J-STD electronic assembly certifications (desired).The ability to obtain and maintain a DoD security clearance (required).Relocation assistance available.
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