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Specialist, Operations Quality

Poziții disponibile: O poziție
141
0
FULL-TIME
Producție & Tehnică
Oradea
Celestica

Responsibilities:

  • 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
Specialist, Operations Quality
Celestica
  • Oradea

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