Quality Engineer
4 weeks ago
We are seeking a motivated Quality Engineer to join a multi-product manufacturing facility. This role supports the Quality Manager in maintaining a robust Quality Management System (QMS) and ensuring compliance with corporate policies, ISO standards, and regulatory requirements. This is an 11-month contract based in Dublin. This is an excellent opportunity for a quality-focused professional to join a dynamic team in the life sciences sector.
Key Responsibilities:
1. Develop, implement, and maintain the Quality Management System (QMS), including document control, change management, CAPA, and complaint handling.
2. Perform internal audits and support external audits for regulatory and customer compliance.
3. Oversee supplier quality management and conduct supplier audits as necessary.
4. Support product realization activities, such as validation, process capability, and equipment qualification.
5. Perform risk assessments and implement quality risk management strategies.
6. Manage the testing, review, and disposition of production batches and raw materials.
7. Collaborate with customers during audits and resolve quality issues through effective communication.
Qualifications and Skills:
1. Bachelor's Degree in Engineering or Science.
2. 3 years’ Experience in a regulated industry (e.g., pharma, biopharma, medical device) within a manufacturing environment.
3. Previous roles in quality system development or implementation in manufacturing.
4. Strong understanding of ISO standards, cGMP practices and lean manufacturing.
5. Knowledge of sterile programs and sterility management is desirable.
6. Proficient in Microsoft Office Suite and quality-related software.
7. Strong analytical, communication, and problem-solving skills with a team-oriented mindset.
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