Quality Specialist II
Carlsbad, CA
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.
More About Isto
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
- Ensure product compliance: Guarantee products meet required quality standards before they are sold to consumers. This includes:
- 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.
- Conduct various functional tests such as:
- Conduct final inspections as per AQL ANSI (Acceptance Quality Limit).
- Quality Sample Submissions
- Sample submission associated with product release such as but not limited to:
- Environmental Monitoring.
- Residual Moisture.
- Product Leak Test.
- Sample submission associated with product release such as but not limited to:
- 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.
- Incoming/Receiving Inspections:
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.
Schedule: Full time
Pay: $71,000 - 75,000 Salary/year
Interested in applying?