Job Summary:
We are seeking a Quality Engineer to support manufacturing, product development, and quality improvement initiatives. This role focuses on maintaining regulatory compliance, driving process improvements, and collaborating with cross-functional teams to enhance product quality and performance.
Key Responsibilities:
- Collaborate with all departments on manufacturing, product development, transfer, and improvement projects.
- Support the design verification process by reviewing protocols, reports, and quality documentation.
- Apply process validation techniques, including risk management and statistical methods, in line with regulatory requirements.
- Support supplier qualification, assessment, and audit activities.
- Generate and manage NCRs, CAPAs, complaints, and deviations, ensuring effective and timely closure.
- Manage validation and monitoring activities related to particulate and biocontamination control.
- Process and close change requests in a timely manner.
Qualifications:
- Degree in Engineering or a related Science discipline, with experience in an engineering function.
- Minimum 3 years’ experience as a Quality Engineer or similar role in a medical device manufacturing environment.
- Strong technical skills, analytical problem-solving ability, and excellent attention to detail.
What’s Next?
- Click “Apply Now” or contact me at +353 21 461 5740 or pkiely@sigmar.ie.
- If this role isn’t the right fit, I’d still love to hear from you about other opportunities!
