What are the responsibilities and job description for the Quality Engineer position at Actalent?
South FL Medical Device Manufacture in need of Quality Engineer!
Description:
Responsible for ensuring that the quality system requirements are on the performance of the quality system and any need for improvement to management with executive authority for review. Ensuring the promotion of awareness of applicable regulatory and quality management system requirements throughout the organization.
- Ensure compliance with all applicable regulatory and statutory requirements
- Manage and maintain regulatory QMS
- Arrange audits both internal and external
- Remediate/close audit findings
- Ensure processes are compliant and followed
- Act as CAPA Project Lead, work with internal CAPA Owners to establish resource commitments, schedule team meetings, assist in the development of CAPA plans, and ensure deliverables are managed to project timelines
- Responsible for identifying product complaints corrective actions and ensuring closure in accordance with company guidelines and external regulatory requirements
- Leads supplier quality function concentrating on the development of existing suppliers through focus on capabilities and robust corrective actions
Qualifications:
-3 years within Quality Engineering
-Lead CAPA process
-Non conformance experience
-Medical Device Experience
-Documentation
Nice to have:
Bachelors Degree in engineering
ISO 13485:2016, FDA CFR’s: 21CFR803, 806, 807, 820,
Canadian Medical Device Regulations SOR 98-282, MDD 93/42/EEC, ISO 14971:2012, EC 53:2013
ASQ Certification preferred
ISO 13485:2016 Certification
About Actalent:
Actalent connects passion with purpose. Our scalable talent solutions and services capabilities drive value and results and provide the expertise to help our customers achieve more. Every day, our experts around the globe are making an impact. We’re supporting critical initiatives in engineering and sciences that advance how companies serve the world. Actalent promotes consultant care and engagement through experiences that enable continuous development. Our people are the difference. Actalent is an operating company of Allegis Group, the global leader in talent solutions.
The company is an equal opportunity employer and will consider all applications without regards to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.
