What are the responsibilities and job description for the Validation Engineer position at Actalent?
For immediate consideration, please apply directly to this job posting AND email biacosta@actalentservices.com with the following:
- WORD copy of updated resume
- 4-5 bullet points highlighting your qualifications for the role
Medical Device in the Los Angeles Area is seeking a Validation Engineer.
Description:
- Initiate and lead the development /review of validation policies, master plans and schedules, and protocols and quality engineering issues.
- Support site production and engineering functions in process quality improvement activities.
- Support the internal and supplier audit processes. Perform internal and/or supplier audits as required.
- Support the risk documentation process, ensuring that product FMEAs, Hazard assessments, etc.
- Initiate and lead investigations involving manufacturing nonconformances, product or component failures, customer complaints, or product returns by leading or participating in the investigation process, technical troubleshooting, FMEA, hazard, or other risk analysis, determining root cause and recommending CAPA/SCRs.
- Interface with external auditors (Notified Body, FDA, etc.) during audits participate in the preparation and completion of corrective action plans as needed.
- Apply statistical methodologies, risk analyses and other quality engineering tools to manufacturing and design related issues.
- Compile Quality metrics, analyze trends and report to Quality Management.
- Initiate and lead design process characterization studies (DOE, R&R) conduct statistical analysis of results to identify critical parameters and improves process capability.
- Participate in Design Control on New Product development teams advise the team on design control requirements develop, review and approve design control deliverables related to quality engineering and validations.
Skills:
IQ, OP, QP, medical device, validation protocols, validation, ISO 13485, quality assurance, audits
Top Skills Details:
IQ, OP, QP, medical device ,validation protocols
EXPERIENCE
- 2-3 years of experience in validation and/or quality engineering in the medical device or pharmaceutical industries
- Experience writing validation protocols (IQ, OP, PQ)
- Engineering Degree
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.
