Corporate Director of Quality- Works on site in Williamsport, PA
Reports to VP of Operations
Summary
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 a 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
Along with site stakeholders, 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
Assure the interpretation of 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 (e.g., internally caused, supplier-caused, and customer-warranty)
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
Education/License/Experience Required
Bachelor’s degree in a STEM
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.
