Immediate need for a talented Engr 3, Quality. This is a 06+ Months Contract opportunity with long-term potential and is located in San Diego, CA (Remote role but will need to travel to the site for audits). Please review the job description below and contact me ASAP if you are interested.
Job ID:26-12038
Pay Range: $57 - $67/hour. Employee benefits include, but are not limited to, health insurance (medical, dental, vision), 401(k) plan, and paid sick leave (depending on work location).
Key Responsibilities:
- Provides continuous and rigorous assessment of CAPA activities and documentation to assure compliance with internal policies in general and specific to CAPA process, FDA regulations, ISO 13485, Medical Device Requirements, and governmental regulations through the review of CAPA records at every phase.
- Participates in CAPA Board, management reviews, and audits.
- Provides guidance, support, and mentorship to CAPA Owners regarding the CAPA process, root cause analysis methodologies, CAPA record content, statistical sampling plans for effectiveness plans, and CAPA software tools.
- Collaborates with engineering and support functions to ensure quality CAPA reviews are performed in a timely manner.
- Devises and implements methods and procedures for inspecting, testing, and evaluating the effectiveness and accuracy of corrective actions ensuring no impact to products, processes or patient safety.
- Ensures CAPA records contain proper bounding and containment and applicable global holds or field actions are initiated.
- Ensures proper objective evidence is attached to CAPA records as needed.
- Will train, coach, guide & mentor CAPA process stakeholders on both base CAPA process execution and best practices employed to ensure robust quality record generation for CAPA and related records.
Key Requirements and Technology Experience:
- Skills-Minimum of 7 years of CAPA/Quality experience
- Understanding of FDA regulations (21 CFR 820, 210/211 as applicable and Part 11), ISO 13485, and quality requirements and Trackwise QMS system experience
- Experience working with non-conformances, corrective and preventive actions, and field actions.
- To be considered for this role, please ensure the minimum requirements are evident on your resume.
- Bachelor’s degree in an engineering field is required
- Minimum of 7 years of CAPA/Quality experience
- Trackwise QMS system experience
- Experience in medical device, pharmaceutical and/or a comparable regulated environment.
- Experience working with non-conformances, corrective and preventive actions, and field actions.
- Understanding of FDA regulations (21 CFR 820, 210/211 as applicable and Part 11), ISO 13485, and quality requirements
- Experience owning CAPAs which conducted effective root cause investigation, corrective and preventive action planning and execution and verification of effectiveness techniques.
- Strong analytical, process improvement, critical thinking, and decision-making skills.
- Ability to create a CAPA gold standard for the CAPA program.
- Influence management skills: ability to work constructively across all functions of the organization as well as external customers.
- Project management skills.
- Experience reviewing technical documentation.
- Strong written and verbal communication skills.
- Experience with internal and external audits.
- Experience with FDA warning letters and/or consent decrees
Our client is a leading medical technology Industry and we are currently interviewing to fill this and other similar contract positions. If you are interested in this position, please apply online for immediate consideration.
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