Drives the Quality aspects of a new Health Tech Customer (HTC) or New Product Introduction
Participates in releasing Quality Plans, Control Plans, First Article reports
Creates, publishes, reviews, controls and constantly improves process documentation
Develops, maintains, and communicates Change management processes in conformance with ISO, Food and Drug Administration (FDA) standards, Medical Device and Diagnostics standards and regulations, and Customer’s requirements
Initiates and participates in an annual review process to ensure data integrity and revises existing documentation to reflect process changes
Collects data/information releasing analysis and reports
Acts as the lead auditor for Internal Quality System Audits. Plans, directs, performs, and reports the results of process, product, systems, supplier, and ISO quality audits
Acts as contact person in external second party or third party audits in the team of the Management Responsible for the audited systems
Performs independent, comprehensive reviews of the existence, correctness and effectiveness of standards and controls used to perform specific functions
Develops, documents, and monitors key processes such as the Design Transfer and Validation Process, Corrective Action Process, Audit Process etc.
Provides consultation and training in the areas of Health Tech Quality requirements, Quality Tools, Statistical Process Control, Risk Management, Workmanship, PCA skills, standards, audit, etc.
Authority:
take steps to eliminate, document and correct problems affecting product quality;
approves and maintains DMRs and DHRs;
has the authority and responsibility to act autonomously in stopping a process that is known or suspected to have an impact on quality;
has the authority and responsibility to make a final decision on acceptance of the product throughout the manufacturing process and before the product is shipped;
sign the certificate of conformity (CoC) for the products approved by Celestica for shipment.
Requirements:
Bachelor’s degree in related field
Usage of computer (Office, Minitab etc.)
Good command of written & spoken English
Knowledge and experience in Health Tech (ISO 13485 and FDA CFR 821/210/211 regulations)
Strong understanding of quality systems
Good analytical and problem solving skills
Ability to exercise good judgment in implementing change orders that affect pricing, costs, and manufacturing processes
Ability to effectively communicate with a wide variety of internal and external customers
3 to 6 years relevant experience in Quality Engineering
Diagnostics manufacturing environment is essential
High level teamwork player, resistant to stress/critical situations
Ability to prioritize and problem solve a variety of tasks to ensure their timely and accurate completion
Ability to communicate effectively, both verbally and in writing, with a wide variety of internal and external customers
Working knowledge of engineering and supply chain systems, inventory management and planning process is an advantage
Lean Six Sigma knowledge is advantage
Lead Auditor experience and/or certification is advantage
Strong basic technical knowledge is advantage.
Project Management Training/Experience – an advantage