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.

Salary: $71,000- $75,000/year

Duties and Responsibilities

Overall Responsibilities:

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

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.

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.

Continuous Improvement

• Drive continuous improvement: Utilize internal audits and data analysis to identify areas for improvement and streamline workflows

Essential Duties and Responsibilities

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:

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.

Preferred Certification

• Certification as a Quality Auditor (ASQ) is preferred for years of experience auditing suppliers, medical device manufacturers, and/or tissue banks.

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.