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. 

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.

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:

• Five 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
  • Six 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.