Quality Systems Specialist

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

Job summary

Elixir Medical Corporation is seeking a qualified professional to maintain and improve the quality system in Milpitas, CA. The role requires 5–7 years in regulated environments, strong CAPA and audit experience, and CAD/PLM familiarity.

Onsite position with a competitive salary range of $110,000–$125,000 per year. The candidate will manage document control, assist with complex documentation, execute validations, and support supplier quality programs while collaborating across functions to ensure

Qualifications

• 5-7 years of experience in regulated medical device, pharmaceutical, or similar environments.
• Strong knowledge of CAPA, audits, supplier control and document control.
• ISO 13485 and GMP auditing experience.
• Internal Auditor certification to ISO 13485 is a plus.
• Excellent technical writing and documentation skills.
• Process or software validation experience 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.
• CAD or PLM systems experience a plus.

Responsibilities

• Maintain quality system in compliance with ISO 13485, 21 CFR 820, and GMP requirements and drive improvements.
• Work with cross-functional teams to assess suppliers and track due dates in supplier system.
• Maintain current versions of external standards in QMS.
• Assist with complex document changes and development of procedures.
• Plan, prepare and review quality documentation and procedures.
• Administer electronic QMS and support data collection for investigations.
• Drive CAPA closure and monitor progress of CAPA actions.
• Perform environmental monitoring and microbiological evaluation as needed.
• Write and present reports to management and communicate changes to staff.
• Support audits of documents and records and assist during external audits.
• Execute validation protocols and generate reports.
• Review manufacturing and QC records as needed.

Skills

Quality systems

Auditing

Documentation

Project management

Communication

Analytical thinking

Problem solving

Interpersonal skills

Education

Bachelor's degree in Engineering or Science

Microbiology background

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.