Quality Engineer - Day Shift
CREGG Group is seeking a highly skilled Quality Engineer for a permanent role based in Galway. This dedicated professional will join our team, working closely with our client, a leader in the pharmaceutical and medical device sector.
This pivotal role plays a crucial part in maintaining high-quality standards across manufacturing, validation, and risk management activities.
Roles and Responsibilities
* Report any Health and Safety incidents and near misses, ensuring a safe working environment.
* Perform Electrical, Mechanical, Hydraulic, and Pneumatic isolation of equipment to ensure safety during maintenance.
* Evaluate the Quality Management System (QMS) to ensure compliance with customer requirements, ISO standards, and all applicable regulatory standards.
* Provide technical direction and input into qualification and validation activities in collaboration with the NPI, Design, Engineering, and Production teams.
* Lead validation activities (IQ, OQ, PQ, PPAP, FAI) to ensure product compliance.
* Design methods and procedures for inspecting and testing finished products to meet regulatory standards.
* Review, update, and maintain existing quality management processes and procedures.
* Conduct root cause analysis for quality issues and manage Non-Conformances (NCs) and Corrective and Preventive Actions (CAPAs).
* Oversee and maintain quality assurance protocols and methods for processing materials into finished or semi-finished products.
* Analyze data to identify trends and recommend updates or changes to quality standards and procedures.
* Participate in continuous improvement programs aimed at enhancing manufacturing, quality, and safety processes.
* Perform risk management activities, including Failure Modes and Effects Analysis (FMEA) and risk assessments.
Qualifications & Professional Skills
* Bachelor's degree or diploma in Quality Assurance, Engineering, Life Sciences, or a related field.
* 1+ years experience in quality engineering or a related discipline preferred.
* Proficiency in MS Excel and the Microsoft Office Suite.
* Strong attention to detail with excellent verbal and written communication skills.
* Understanding of customer requirements in terms of quality and delivery.
* Able to impart knowledge clearly and concisely.
* Strong decision-making and reporting abilities.
* Able to work effectively as part of a team with shared goals.
Benefits
* Paid Holidays
* Canteen
* Parking
* Pension
* Educational assistance
* Laya Healthcare
* Laptop
We are offering a challenging and rewarding career in quality engineering to those who apply.