18 Quality Assurance Manager - (JP9589) Jobs in Thousand Oaks, CA
3 Key Consulting is Hiring a Quality Assurance Manager - (JP9589) Near Thousand Oaks, CA
- Quality Assurance experience.
- Experience with technical methods.
- Experience with combination products.
- Review and approve FP Mechanical/Physical methods, method development reports, user requirements, method validation reports and method transfer reports.
- Provide oversight to ensure accuracy and precision of methods to measure final product specifications.
- Review material characterization data, work with Regulatory to inform teams of any regulatory requirements that must be met.
- Facilitate PAI readiness for notified bodies and act as escort.
- Review method transfers across sites and suppliers to provide quality perspective and approval.
- Provides advice to regulatory on submission strategies associated with platforms and physical methods.
- Inform other Quality functions of any material requirements.
- Provide quality expertise and technical knowledge to Final Product Key External Initiative (KEI).
- Co-develop training materials for method transfers and stability method transfers with FPT Core Technologies.
- Co-develop training materials for stability method transfers with FPT Core Technologies
- BS or BE in Engineering and previous experience in the medical device and/or pharmaceutical industries.
- 8 years current experience with engineering processes/procedures and quality tools.
- Major contributions to or the leadership of projects from development through the 510k and PMA approval process.
- Experience with material & test specs generation, protocol & report writing, process & test development, prototyping, design verification/validation, DOE/SPC process optimization & validation (IQ, OQ, PQ), P/DFMEA.
- Product design/development (design control) from concept to post product launch for Europe (EMEA/CE Mark) & US (FDA/PMA/510k) submissions.
- Experience in test or inspection method design and development.
- Small scale device assembly and/or benchtop testing experience..
- Experience with Automated Test Equipment (ATE).
- Experience with regard to Measurement Systems Analysis/GRR principles, including study design/execution/troubleshooting.
- Strong critical thinking, problem solving, risk assessment, and risk management skills.
- Must be capable of working on multiple projects in a deadline driven environment.
Video Skype Panel InterviewWe invite qualified candidates to send your resume to resumes@3keyconsulting.com. If you decide that you’re not interested in pursuing this particular position, please feel free to take a look at the other positions on our website www.3keyconsulting.com/careers. You are also welcome to share this opportunity with anyone you think might be interested in applying for this role.
Job Summary
Full Time
Business Services
$113k-141k (estimate)
12/13/2023
06/15/2024
3keyconsulting.com
WEST HILLS, CA
100 - 200
2009
Private
$50M - $200M
Business Services
Related Companies
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