Quality Specialist II

Isto Biologics is a growing, 100% biologics-focused company committed to helping patients heal faster by providing a range of advanced solutions to surgeons of varying specialties. Isto is seeking a full-time Quality Specialist for their Carlsbad, CA location. 

Position is full-time, in office.

Duties and Responsibilities

Overall Responsibilities:

1. Product Quality Assurance
   • Ensure product compliance: Guarantee products meet required quality standards before they are sold to consumers. This includes:
     • Conducting and/or reviewing appropriate testing procedures during manufacturing processes.
     • Identifying and reporting any issues or deviations in product quality, including nonconformance issues, defects, and procedural errors
2. Quality Management Systems (QMS) and Documentation
   • Manage QMS: Assist with the overall management of the QMS, which involves tracking quality events and incidents.
   • Documentation Control: Assist and maintain data for the control of documentation.
3. Audits And Supplier Management
   • Internal audits: Conduct internal audits and recommend improvement(s)
   • External/supplier audits: Conduct external/supplier audits.
   • Supplier qualification and reassessment: Qualify new suppliers and reassess current suppliers.
   • QMS Logs: Audit logs for documents, corrective and preventive actions, and various reports (DCN’s, CAPAs, Test Protocols, Deviations, NCMRs, etc.).
   • Independent Process Oversight: Provide independent oversight of processes, verifying compliance with company standards and policies.
4. Continuous Improvement
   • Drive continuous improvement: Utilize internal audits and data analysis to identify areas for improvement and streamline workflows

Essential Duties and Responsibilities

1. Quality Inspection
   • Incoming/Receiving Inspections:
     • Perform and/or review inspections of incoming materials to ensure they meet specifications. This includes conducting visual and measurement tests.
     • Perform ERP transfers as needed to manage material movement between sites.
     • Document inspection results in reports, logs, and a quality database.
   • In-Process Inspections: Inspections happen at specific production stages.
     • Perform and/or review in-process production inspections to confirm specifications.
     • Conduct per AQL ANSI (Acceptance Quality Limit) for visual inspection of products.
     • Complete all applicable forms outlined in per appropriate procedures.
     • Perform ERP functions as needed to manage product movement between sites.
   • Post-Process Inspections:
     • Conduct final inspections as per AQL ANSI (Acceptance Quality Limit).
       • Communicate nonconformances to the production supervisor, as needed.
       • Perform ERP functions as needed to manage product movement between sites.
       • Functional Testing:
         • Conduct various functional tests such as:
           • Label inspections.
           • Pouch-peel inspections.
   • Quality Sample Submissions
     • Sample submission associated with product release such as but not limited to:
       • Environmental Monitoring.
       • Residual Moisture.
       • Product Leak Test.
   • Supplier Approval Program
     • Supplier Communication and Documentation: Communicate with suppliers and assist in gathering necessary documents for approval.
     • Supplier Procurement: Coordinate and assist with completing all appropriate onboarding forms and updating the approved supplier list.

Required Education and Experience

Education and/or Formal Training:

1. Required Education
   • A U.S. bachelor’s degree or its non-U.S. equivalent is required.
   • Degrees in life sciences, technical fields, or related fields are preferred.
2. Preferred Certification
   • Certification as a Quality Auditor (ASQ) is preferred for years of experience auditing suppliers, medical device manufacturers, and/or tissue banks.
3. Experience Equivalency
   • A combination of education and experience may be considered in lieu of meeting the exact requirements listed above and below.

Experience:

• Three or more years of experience in the medical device industry, including working in a cleanroom environment and other relevant sectors.
• Experience in the allograft industry, including knowledge of 21 CFR Part 1271, is desired but not required
• Regulatory and Quality Management Systems Experience
  • Three or more years of experience with ISO standards (e.g., ISO 13485 for quality management systems) and FDA regulations (e.g., 21 CFR Part 820 for medical device quality systems).
• Auditing experience
  • Three or more years of experience in conducting internal and supplier audits.