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 providing transformative solutions with distinctive, sustainable, and long-term value. ECI has a proven track record of delivering full product lifecycle consulting on a variety of challenging and exciting projects. Our collaborative culture, welcoming team, and flexible employment and benefit options enable us to maintain strong relationships with the most talented individuals in the industry.
About The Role
This role involves evaluating and communicating quality issues to suppliers, applying systematic problem-solving methodologies to identify, prioritize, and resolve quality 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 as required.
4. Review existing mold validations thoroughly.
5. Manage control of 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 experience in the field.
2. Awareness of applicable worldwide regulations for quality systems (EU MDR, ISO 13485, 21 CFR 820, etc.) (preferred).
3. Experience with quality processes such as CAPA, complaint management, and risk management (preferred).
4. Experience conducting audits to international standards like ISO 9001:2015 and ISO 13485:2016.
5. Results-oriented with strong organization and time management skills, with a focus on processes.
6. Effective communication skills in an international environment with external partners and stakeholders.
Equal Opportunity Statement
ECI is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, creed, color, religion, national origin, sex, age, disability, sexual orientation, gender identity or expression, genetic information, veteran status, marital or citizenship status, or any other protected status by law.
Note: Candidates must be authorized to work in the U.S. without sponsorship now or in the future. ECI does not sponsor work visas for this role.
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