ESSENTIAL JOB FUNCTIONS
This position will be responsible in developing and executing the quality strategy for the Center Of Excellence (COE) site. The Quality Assurance Director will lead the quality team to provide the highest levels of value to the business. This role is responsible for ensuring the quality level of the products produced and supplied are the best in class. The Quality Assurance Director is responsible for overseeing the Quality Management System, Quality Engineering, Document Control and Inspection departments.
- Responsible for the overall management of the Quality Department, including staff supervision.
- Serve as the designated Management Representative providing quality oversite, ensuring quality objective are established and monitored, and provide visibility to quality performance to management
- Serve as Quality interface for customers.
- Set quality targets, measure achievement, and facilitate process of developing action plans to achieve targets.
- Identify the appropriate metrics & KPIs to measure internal & customer quality outcomes & processes; present quality metrics to internal & external stakeholders
- Drive a Root Cause Problem Solving (RCPS) culture throughout the organization and throughout product lifecycles.
- Leads corrective and preventive actions; proactively identifies and executes on opportunities for preventive actions.
- Partners with Operations and Manufacturing Engineering to drive continuous improvement through business and quality objectives.
- Works closely with cross-functional teams on new product introductions, transfers, and sustaining projects with a focus on Design for Manufacturability / Testability / Reliability.
- Provides Quality Engineering support for production; addresses non-conformances through the NCMR system, driving escalation when risk level warrants.
- Supports the supplier qualification program; including supplier audits and associated follow-up activities and provides support to IQA function in dealing with non-conforming materials.
- Participates in site internal audits and facilitates external audits.
- Manages non-conforming material's review board (MRB) system including WIP rejects and incoming materials.
- Support operations management in assessing RMA's and process defects in support of corrective action programs.
- Some travel is required with this role, about 25% to customer and supplier sites.
- Lead special projects as assigned.
- Bachelor's degree in Engineering or other technical discipline preferred.
- 10+ years of progressive experience in Quality Assurance.
- Comprehensive knowledge of quality assurance in an operations environment.
- Excellent knowledge of ISO 9001 and 13485.
- Internal auditor and continuous improvement experience required.
- Excellent written/verbal/teaching skills with attention-to-detail. (not necessary to include this is automatically)
- Strong analytical skills and demonstrated PC, Microsoft Word, Excel and Access database skills.
- Experience or trained in Six Sigma methodologies, TQM, Lean fundamentals preferred.
- Must have a working knowledge of quality programs, with experience in a variety of measuring/inspection instruments, auditing processes and closed loop corrective action programs.
- Formal experience and training in multi-disciplined project/program management required.
- Leadership SkiLLS
- Establish strong and sustaining relationships with Production, Engineering, external Regulatory bodies and others and will be recognized as an excellent team player within the total organization on site.
- Comfortable challenging the status quo and being a change agent on cultural development.
- Leads, coaches, and develops department team members to support changing business needs.
- Engage site leadership on Cost of Quality (COQ) improvements in each department.
- Drive a Customer Centric Quality Organization aligned with Customer performance expectations.