Director, Quality Assurance

JOB SUMMARY

The Director Quality Assurance oversees the efficient operations of the Quality Assurance department which is composed of the Quality Engineers (staff) Inspectors (union) Laboratory Technicians (union) and Inspector Technicians Ultrasonic (union). The Director Quality Assurance reviews and monitors Government Customer and Industry Quality system requirements to assure procedures are adequate and in compliance; oversees Regulatory Agency certification and periodic audits; is responsible for formulating documenting implementing and assuring compliance to Quality policies plans and standards; and represents the organization as the ISO / AS9100 Quality representative among other duties.

WORKING RELATIONSHIPS

This position reports to the CEO. The Director Quality Assurance liaises closely with the VP Operations VP Supply Chain Program Management and Project Management. Reporting to the Director Quality Assurance are the Quality Engineers Lab Technicians and the Inspection Team.

WORK PERFORMED

• Directs and manages the efforts of the Quality Assurance and Quality Control Teams
• Assists the VP Operations in following up on the assigned tasks given
• Assists in the measurement of operational performance and training needs
• With minimum direction is responsible for formulating documenting implementing and assuring compliance to Quality policies plans and standards
• Responsible for Regulatory Agency certification and periodic audits
• Manages and mentors Quality Engineering Inspection and production teams
• Reviews and monitors Government and Customer Quality system requirements to assure procedures are adequate and in compliance
• Analyzes internal and external Quality data and initiate effective corrective actions to reduce and eliminate adverse trends
• Manages periodic Quality Management Reviews
• Provides Quality technical support to all process owners
• Leads by example demonstrating a consistent professional manner
• Creates a team environment with all fellow managers and their staffs
• Ensure timely responses to all Quality activities and issues to meet scheduled needs of both internal and external customers
• Conducts effective meetings by strong understanding of roles responsibilities & action plans
• Represents the organization as the ISO / AS9100 Quality representative
• Monitors and assures compliance of all processes including NADCAP ISO / AS9100
• Manages all aspects of ISO & Regulatory compliance
• As needed performs the essential duties of a Quality Engineer and other related tasks

CONSEQUENCES OF ERROR / IMPACT OF DECISIONS

This position is expected to make strategic decisions regarding the planning monitoring and evaluation of the Quality Management System based on feedback from Operations Programs Suppliers and the Customer. The consequences of error are serious in that poor product quality translates to higher costs slower delivery decreased profit poor customer satisfaction low audit ratings and the highest risk increased chance of a product failure in the field. Accountability initiative sound judgment and decisiveness are required.

SUPERVISION RECEIVED

This position works independently to prioritize and complete assigned tasks. Assignments are periodically reviewed for progress through biweekly meetings with the CEO. Work is checked and reviewed upon request when tasks deviate from established guidelines.

SUPERVISION GIVEN

Oversees the Quality Control Supervisors and coaches QC Supervisors in any issues with the Inspectors. Leads trains and mentors the Quality Assurance Engineers. Provides day-to-day supervision of the lab. Delegates issues as needed and follows up to ensure completion.

QUALIFICATIONS AND SKILLS

Required Experience :

Director

Key Skills

Quality Assurance,FDA Regulations,ISO 9001,Root cause Analysis,Biotechnology,Clinical Trials,Quality Systems,Food Processing,Quality Control,Quality Management,cGMP,HACCP

Employment Type : Full Time

Experience : years

Vacancy : 1