Quality Assurance Specialist

6 days ago

Waterford, Waterford, Ireland beBeeQuality Full time €78,280 - €101,400
Job Overview

We are seeking a seasoned professional to join our team as a Quality Specialist. This role plays a critical part in ensuring product quality and patient safety through the effective execution of quality processes.

The ideal candidate will have a strong background in quality management, with experience in regulated industries such as medical devices. They will be responsible for providing quality direction, governance, and best practices across the Quality Management System and the programs they support.

This role supports multiple concurrent projects to ensure regulatory and quality compliance is maintained throughout the product development lifecycle, including manufacturing, commercialization, and life-cycle management.

Key Responsibilities:
  • Provide quality direction and governance across the Quality Management System
  • Support multiple concurrent projects to ensure regulatory and quality compliance
  • Develop comprehensive project plans, including scope, timelines, budget, resources, and project success criteria
  • Collaborate with cross-functional teams to coordinate project execution and ensure project objectives and success criteria are met
  • Author, review, and/or approve design history documentation and design manufacturing documentation
Requirements:
  • Bachelor's Degree in Engineering or Science or equivalent experience required
  • Minimum 5 years of experience in a regulated industry (e.g., Medical Device), including Product Manufacturing and Post Market Surveillance Activities required
  • Demonstrated experience independently defining, planning, and executing projects in highly regulated environments with a track record of success required
  • In-depth knowledge of cGMP regulations, ISO 15378 or ISO 13485, 21 CFR 820, ISO 14971 required
Preferred Qualifications:
  • Experience with MasterControl, SAP, Share Point
  • Experience with ISO 11040, ISO 11607
  • Expertise in quality management tools, standards, policies, and procedures – APQP, PPAP, MSA, SQC etc
Benefits:
  • Sedentary work involves sitting most of the time
  • 10% travel requirement
  • Manufacturing/Six Sigma Green Belt Certification or Black Belt Upon Hire preferred
Additional Requirements:
  • Exhibit a strong 'quality first' mentality and ensure that product and process quality are held to the highest standard
  • Excellent written and oral communication and interpersonal abilities
  • Critical reading skills and maintain high attention to detail, accuracy, and overall quality of work

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