Quality systems engineer i (remote)

Descripción general

The Quality Systems Engineer I is responsible of supporting quality system implementation and improvements to ensure compliance with regulatory requirements, including but not limited to CAPA (Corrective/Preventive) and Internal Quality Audit System. Prepare, analyze, and report quality system metrics to ensure quality system effectiveness.

Responsibilities:
Please ensure such requirements align with the job’s essential functions. Essential job functions are a duty or responsibility that is fundamental to the job and the team member must be able to perform. Leader and direct report job descriptions should be evaluated to ensure they do not overlap in responsibilities.
•Support the Corrective Action Preventive Action (CAPA) and Internal Quality Audit Systems.
•Partner with CAPA owner to investigate issues related to, but not limited to, audit findings.
•Support CAPA review board meetings as required.
•Ensure CAPA and Audits records are following good documentation practices and procedure requirements.
•Develop and conduct training related to the CAPA and Internal Quality Audit Systems to users as required.
•Periodically prepare, analyze, and report quality system metrics to ensure quality system effectiveness as required.
•Support the Change Control process.
•Support audit activities as requested.
•Conduct requested audits as scheduled.
•Ensure compliance against standards and regulations of the areas that supports.
•Complete assigned training on time.
•Follow SOPs, internal policies, and requirements.
•Perform investigation and take appropriate action as required.
•Follow SOPs, internal policies, and requirements
•Ability/flexibility to work in a fast-paced environment and technical level
•Take the assigned portable computer home every day, to maintain connectivity to SDC and ability to perform required tasks offsite if required

Requisitos para aplicar

• Bachelor’s degree in Industrial Engineer or similar.
• Experience: At least 1 year of related experience.
• Previous experience working in a medical industry (FDA 21CFR part 820, ISO13485) environment is preferred.
• Software: MS Office, Visio. SharePoint and statistical software are a plus.
• Language: English / Spanish, (minimum Level B2).
• CQE certification or equivalent is a plus.
• Highly detailed-oriented with solid organization skills.
• Problem solving skills.
• Self-directed and motivated with ability to handle multiple tasks.
• Ability to prioritize and adapt quickly to changing needs.
• Oral and Written Communication.
• Ability to write clear, concise, and comprehensive quality documentation.
• Team player.
• Ability/flexibility to work in a fast-paced environment at a technical level.