Quality Systems Specialist

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

Responsibilities will include, but not be limited to:

• Maintain the quality system in compliance with ISO 13485, 21 CFR 820, and applicable GMP requirements, and help drive quality system improvements
• Maintain supplier quality system by working with cross-functional team to assess suppliers, review and update supplier files as needed, and tracking due dates in supplier system
• Maintain current versions of external standards in QMS
• Assist with complex document changes
• Assist teams with planning, preparation and review of quality documentation, including creation of procedures
• Perform assigned activities for administration of electronic QMS
• Provides data collection and general support for timely completion of complaint investigations
• Drive timely closure of CAPAs by assisting with investigations, facilitating corrective action implementation, and monitoring progress of CAPA phases
• Perform environmental monitoring and microbiological evaluation as needed
• Write and present reports to management and communicate changes to affected employees
• Participates in audits of documents and records, and provide support during external audits
• Execution of validation protocols and report generation
• Perform manufacturing and QC records review as needed

Qualifications

Experience

• 5-7 years of experience in small to mid-size Medical Device, Pharmaceutical, or other regulated companies (drug-device combination product a plus)
• Strong knowledge of quality systems (CAPA, audits, supplier control, document control, etc.)
• Prior experience with auditing to ISO 13485 and GMP
• Certification as an Internal Auditor to ISO 13485 is a plus
• Excellent technical writing and documentation skills
• Experience with process or software validations is a plus
• Ability to plan, organize, and manage multiple tasks simultaneously
• Demonstrated analytical and problem-solving capabilities
• Strong written, oral communication, and interpersonal skills
• Prior experience with process validation or software validation is a plus
• Basic experience with Microsoft Windows, Microsoft Office, Adobe Acrobat
• Prior experience with CAD software (Solidworks, etc) or PLM systems (Arena, Windchill, etc) are a plu

Education Requirements

• Bachelor’s degree in Engineering or Science discipline
• Additional background in microbiology is a plus

This position is based in Milpitas, CA and is an onsite position. The salary range of $110K – $125K based on factors including experience, skills, etc.