Quality Engineer
Location: Waterford
Position Summary
The Quality Engineer supports the development and implementation of quality plans, programs, and procedures using quality engineering tools, lean manufacturing concepts, and statistical analysis. The role ensures that product and process quality meet company, customer, and regulatory requirements. The Quality Engineer assists in reviewing, analysing, and reporting quality issues related to manufacturing and assembly, and works cross‑functionally to drive corrective and preventive actions.
Key Responsibilities and End Results
Provide technical quality support during the New Product Introduction (NPI) process, ensuring compliance with healthcare and medical device requirements, including FDA, QSR, and MDD standards.
Apply quality engineering tools and techniques with a strong emphasis on Validation protocols (DQ, IQ, OQ, PQ), cGMP, Process FMEAs (PFMEAs), Generation and maintenance of Device Master Files (DMFs), where applicable.
Use scrap reduction methodologies and process capability analysis to establish and maintain robust, defect‑free manufacturing processes.
Support quality activities related to sterilisation, automation, and equipment/software validation.
Support manufacturing activities within controlled and regulated environments.
Participate in and support internal and external Quality Management System (QMS) audits (auditor trained).
Support and contribute to the Corrective and Preventive Action (CAPA) system.
Liaise closely with manufacturing, engineering, and other departments to drive quality initiatives across operational activities.
Support the implementation of company policies, GMP requirements, and quality systems.
Support all company safety and quality programs and initiatives.
Ensure ongoing compliance with GMP in all practices, documentation, and processes.
Ensure compliance with all GMP training requirements.
Apply a structured root‑cause problem‑solving approach within a team environment.
Align customer specifications with company manufacturing capabilities.
Perform other duties as required based on business needs and the evolution of the department.
Job Specifications
Education and Experience
Degree in Engineering or Science (Mechanical, Electronics, Chemistry, or related discipline) with a minimum of 2 years’ experience in a relevant Quality role;
or A minimum of 5 years’ experience in a relevant Quality role.
Strong knowledge of Quality Management Systems and applicable regulatory standards.
Competent in quality engineering tools, validation methodologies, and continuous improvement techniques.
Skills and Attributes
Excellent leadership skills with the ability to motivate and influence team members.
Energetic, enthusiastic, and proactive approach.
Strong organisational, communication, computer, and presentation skills.
Demonstrates initiative, sound decision‑making, and ability to work effectively in cross‑functional teams.
Solution‑driven mindset with a strong focus on performance and results.
For further information, contact Alan on alan@accpro.ie
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