We are looking for Staff CAPA Engineer for our client in Irvine, CA
Job Title: Staff CAPA Engineer
Job Location: Irvine, CA
Job Type: Contract 12 Months
"US citizens and those authorized to work in the US are encouraged to apply. We are unable to sponsor H1b candidates at this time."
- Looking for a strong engineer with solid technical expertise and leadership skills, who enjoys working in a fast paced and rapidly growing environment.
- This Staff Quality Engineer will focus on providing ownership and support of all phases of the CAPA process including investigations, robust root cause analysis, development and implementation of corrective actions, and effectiveness monitoring.
- Additional responsibilities may include performing process improvement projects.
- With the support of subject matter experts (SMEs), lead investigations of complex manufacturing product quality and compliance issues (e.g., CAPA, non-conformances, audit observations) for all production processes based on engineering principles;, perform robust root cause analysis, develop and implement corrective actions, and establish effectiveness monitoring plans
- Manage all phases of the CAPA process for specific events; including documentation, record management, and assembly of robust CAPA files within the CAPA Management System
- Analyze results, make recommendations and develop reports
- Quality Systems Engineering support, including Post-Market Quality Engineering support
- Applies knowledge of quality engineering principles and methods to ensure compliance with regulatory requirements and client's systems/procedures to optimize product development, internal and external device manufacturing, and device distribution
- Guide others in resolving basic issues in specialized area based on existing solutions and procedures
- Train, coach, and guide lower level employees on CAPA procedures
- Other incidental duties assigned by Leadership
Required Education & Skills:
- A Bachelor's Degree or equivalent in Engineering with a minimum of 6 years related experience in the industry required ; A Master's Degree or equivalent in Engineering field with a minimum of 2 years of experience in the industry
- Working knowledge of the Domestic and International regulatory Medical Device regulations (FDA 21 CFR 820, ISO 13485; and other applicable regulatory requirements)
- Advanced problem-solving, organizational, analytical and critical thinking skills
- Strong leadership skills and ability to influence change
- Strong documentation, communication and interpersonal relationship skills including negotiating and relationship management skills
- Ability to prioritize, plan & evaluate deliverables to established strategic goals
- Ability to interact professionally with all organizational levels
- Ability to manage competing priorities in a fast paced environment
- Must be able to work in a team environment, including inter-departmental teams and key contact representing the organization on contracts or projects
- ASQ Certified Quality Engineer (CQE), Quality System Lead Auditor, Certified Six Sigma Black Belt (CSSBB), or related quality/regulatory certifications preferred