Senior Quality Systems Specialist - Medical Devices

Elixir Medical Corporation; Milpitas (CA); On-site; USD 110,000 - 125,000; Full time

Job summary

Elixir Medical Corporation in Milpitas, CA is seeking a quality systems professional to maintain ISO 13485 and 21 CFR 820 compliant operations. You will drive improvements, manage supplier quality, and assist with documentation changes and validation activities.

This onsite role emphasizes cross-functional collaboration and robust technical writing skills. The position requires 5–7 years in regulated medical device or pharma settings, with strong CAPA and audit experience.

Qualifications

• 5-7 years of experience in medical device/pharma or regulated environments.
• Strong knowledge of CAPA, audits, supplier control, and document control.
• Auditing to ISO 13485 and GMP experience preferred.
• Internal Auditor ISO 13485 certification a plus.
• Excellent writing and documentation skills.
• Experience with process or software validations is a plus.
• Able to plan, organize, and manage multiple tasks.

Responsibilities

• Maintain quality system compliance with ISO 13485, 21 CFR 820, and GMP.
• Collaborate with cross-functional teams to assess suppliers and track due dates.
• Update external standards in the QMS and assist with document changes.
• Prepare and review quality procedures and documentation.
• Administer electronic QMS and support complaint investigations.
• Drive CAPA closure and monitor progress through phases.
• Assist with environmental monitoring and microbiological evaluations.
• Prepare reports and communicate changes to staff; support audits.

Skills

Quality systems

Documentation

Auditing

Cross-functional collaboration

Analytical thinking

Communication

Problem solving

Process validation

Software validation

Education

Bachelor’s degree in Engineering or Science

Background in microbiology

Tools

Solidworks

Arena PLM

Windchill

Microsoft Office

Adobe Acrobat

Job description

Elixir Medical Corporation in Milpitas, CA is seeking a quality systems professional to maintain ISO 13485 and 21 CFR 820 compliant operations. You will drive improvements, manage supplier quality, and assist with documentation changes and validation activities.

This onsite role emphasizes cross-functional collaboration and robust technical writing skills. The position requires 5–7 years in regulated medical device or pharma settings, with strong CAPA and audit experience.