Supplier Quality Engineer

ECI; Sligo; On-site; EUR 45,000 - 60,000; Full time

Job summary

A leading consulting firm in the life sciences industry is seeking a quality specialist to evaluate and resolve quality issues with suppliers. The role requires strong problem-solving skills and knowledge of quality regulations. Join a collaborative team focused on delivering sustainable solutions.

Qualifications

• Awareness of worldwide regulations for quality systems preferred.
• Experience with quality processes such as CAPA and risk management preferred.

Responsibilities

• Evaluate and communicate quality issues to suppliers.
• Support the development of supplier qualification activities.
• Manage controls for sub-tier suppliers.

Skills

Communication

Organization

Problem Solving

Education

Engineering or Science Degree

Job description

Brief Description

About ECI

ECI’s mission is to be the global leader in professional consulting services for the life sciences industry. Our clients rely on our diverse perspectives and decades of expertise to address their toughest challenges. We pride ourselves on delivering transformative solutions with distinctive, sustainable, and long-term value. ECI has a proven track record of providing comprehensive product lifecycle consulting on a variety of challenging and exciting projects. Our collaborative culture, welcoming team, and flexible employment and benefit options help us maintain strong relationships with the most talented individuals in the industry.

About The Role

The role involves evaluating and communicating quality issues to suppliers, applying systematic problem-solving methodologies to identify, prioritize, and resolve these issues. The role also includes reviewing and approving supplier corrective action plans and verifying their effectiveness.

What You'll Do

1. Support the development and maintenance of supplier qualification and re-qualification activities.
2. Maintain detailed knowledge of ISO 13485:2016, MDSAP, MDR, and ISO standards.
3. Support ongoing quality improvement projects and initiatives.
4. Review existing mold validations thoroughly.
5. Manage controls for sub-tier suppliers.
6. Review process controls.
7. Perform other duties as assigned.

What You Will Bring

1. An engineering or science degree, or valid relevant experience.
2. Awareness of applicable worldwide regulations for quality systems (e.g., EU MDR, ISO 13485, 21CFR820) (preferred).
3. Experience with quality processes such as CAPA, complaint management, and risk management (preferred).
4. Experience conducting audits to international standards such as ISO 9001:2015 and ISO 13485:2016.
5. Results-oriented with strong organization and time management skills, and a focus on processes.
6. Effective communication skills for working with international partners and stakeholders.

Equal Opportunity Statement

ECI is an equal opportunity employer. All qualified applicants will receive consideration regardless of race, creed, color, religion, national origin, sex, age, disability, sexual orientation, gender identity or expression, genetic predisposition, veteran status, marital or citizenship status, or any other protected status.

Applicants must be authorized to work in the U.S. without sponsorship now or in the future. ECI will not sponsor work visas for this position.