Quality Engineering Lead

Full-time

Description

POSITION SUMMARY:

The Quality Assurance Engineering Lead at our Statesville location will work to apply knowledge in the implementation of an integrated Quality Management System (QMS) to ensure full compliance and a continual product process and supplier improvement culture. This individual will work closely with all cross-functional teams to create quality strategies that support customer needs and overall business objectives. Work on and provide solutions to a wide range of difficult problems relating to the quality aspects of design validation and manufacture of medical devices. This person serves as owner and administrator of several aspects of the quality system including but not limited to supplier management customer feedback process control internal audits change management and design control. This quality and compliance professional will be responsible for assuring conformance to product serve as the sites lead ISO Representative.

This position is subject to the International Traffic in Arms Regulations (ITAR) which requires U.S. person status. ITAR defines U.S. person as an U.S. Citizen or U.S. Permanent Resident.

ESSENTIAL JOB FUNCTIONS:

• Plans implements and directs quality program consistent with ISO and AS9100 quality systems.
• Is the site Quality Subject Matter Expert (SME) for all quality adherences including integration and bridging customer corporate and supply base requirements.
• Evaluates current QA and QC procedures and practices for accomplishing department objectives; develops and implements improvements as needed.
• Validates quality product specifications and quality attributes; measures and documents objective evidence; determines operational and performance qualifications; develops and updates the company quality manual as necessary (ISO9001 AS9100D NADCAP and other quality related documents).
• Provides guidance to Engineering during design and specification requirements to best utilize quality processes and techniques.
• Prepares quality documentation and reports by collecting analyzing and summarizing information and trends including corrective actions failed processes recalls return merchandise and re-validations.
• Conducts periodic reviews of manufacturing and quality systems and create improvement cycles based on performance results.
• Interfaces with engineering and manufacturing/operations to ensure customer requirements and specifications are flowed down to products and services.
• Supports manufacturing and quality project planning and scheduling to assure a seamless execution and delivery of products and services.
• Supports quality task sequences planning (work instructions) and workflow for fabrication assembly integration test and shipping/receiving.
• Proficiency in the use of inspection tooling to determine if parts and process yield the dimensional requirements.
• Interfaces with engineering and manufacturing/operations to ensure customer requirements and specifications are flowed down to products and services.
• Supports the company quality performance rating process to continually improve customer satisfaction.
• Customer interface for all quality issues requiring an understanding of OEM specifications and an ability to interpret purchase order flow downs.
• Interface with supply chain/suppliers for all quality RCCA (Root Cause Corrective Action) on purchased or returned parts.
• Performs other related duties as assigned by management.
• Champion ISO9001 AS9100D and NADCAP Compliance.
• AS9100D Subject Matter Expert with the responsibility to support the development implementation and management of the Quality Management System per IS09001 AS9100 and NADCAP.
• Generation of protocols reports; review protocols SOPs product specifications and records.
• Support first article testing test analysis manufacturing processes process documentation project workflow and shipping/receiving.
• Manage quality metrics trends and Lean activities to improve cost quality and schedule performance.
• Direct and coordinate the activities of the quality control function to ensure achievement of company objectives.
• Implement a quality culture of root cause analysis and corrective action to prevent future escapes and continuously improve quality.
• Develop quality plans by conducting analyses; identifying critical control points and preventive measures; establishing critical limits; monitoring procedures corrective actions and verification procedures; and monitoring inventory quality.
• Ensures that quality system requirements are maintained and reported.
• Establish self as quality conduit between company and customer.

Requirements

QUALIFICATIONS:

• A bachelors degree in industrial management quality management or related field.: three to five years related experience and/or training; or equivalent combination of education and experience.
• Successful candidate will have a broad Quality and/or Engineering background with direct experience in customer management contract review and implementation quality management systems non-conformances Root Cause and Corrective Action (RCCA) through the utilization and application of Six Sigma tools.
• Undergraduate technical or business degree desired.
• 6-10 years of Quality QA/QC methodology or Engineering with professional experience in an aerospace manufacturing environment.
• Knowledge of ISO9001 AS9100 and/or NADCAP quality standard requirements.
• Experience in all elements of Quality from design to assembly/inspection/integration/test.
• Proficiency in CMM programming and operations preferred.
• Quality systems or related discipline with AS9100 certification or training.
• Experience in Lean/Six Sigma 5S and Continuous Improvement.
• Experience with the control and disposition of non-conforming material.
• Proficiency with Microsoft Office Suite and relevant applications.
• Ability to communicate effectively and deliver technical presentations.
• Solid analytical skills and solution-driven thinking.
• Detail-oriented to accurately prepare statistical reports and technical documents in support of company objectives.
• Strong business/technical writing presentation planning problem solving organizational project management and decision-making skills.
• Able to create and maintain enthusiasm for new and challenging goals.
• Willingness and ability to learn and engage with ERP system.
• Candidate should be self-motivated flexible and able to succeed with several projects at the same time work accurately under pressure and with a positive work ethic.