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Quality Assurance Compliance Specialist

2 months ago


San Diego, California, United States Innovive Full time
Job Title: Quality Assurance Compliance Specialist

Innovive is a rapidly growing B2B manufacturing company serving the biomedical research industry. We value hard work and credit our team for our success. We are seeking a Quality Assurance Compliance Specialist to contribute to our success through collaboration with suppliers and customers, as well as the engineering, operations, and supply chain teams.

Key Responsibilities:
  • Establish and maintain audit schedules for raw material and service vendors in collaboration with the Supply Chain team.
  • Conduct on-site and/or virtual audits of suppliers and third-party manufacturers to ensure compliance with product specifications and ISO standards.
  • Provide clear and factual feedback to suppliers in the form of written reports, including observations and assessment of corrective and preventive actions to remediate gaps.
  • Participate in/conduct audit activities, including opening and closing meetings, establishment of agendas, and coordination with auditing team members; may include coordination of travel accommodations.
  • Serve as the primary point of contact for the Customer Service team for complaint management, leading investigation, root cause analysis, and training/communication of issues to production or quality teams as needed.
  • Prepare and submit required quality records and documentation for closure and filing of customer complaints.
  • Be an active member of the internal audit team, assisting in the completion of process audits.
  • Develop expertise in NetSuite development of quality-based modules and serve as a point of contact.
  • Lend support and assistance to the Quality Manager with projects as needed, with additional responsibilities to be developed after 1 year of tenure.
Requirements:
  • Critical thinking and problem-solving skills.
  • Attention to detail.
  • Organizational, planning, and documentation skills.
  • Strong written and verbal communication skills.
  • Brings values and a sense of ownership to the position.
  • Ability to take direction as well as initiative.
  • Teamwork.
Qualifications & Experience:
  • Experience in quality or systems management.
  • 5 or more years of relevant experience required.
  • Experience in the FDA industry is a plus.
  • Experience working with Google Suite is a plus.
Location & Benefits:

San Diego, CA

We offer excellent benefit packages and employee programs, including paid time off, paid holidays, medical, dental, vision, life insurance, disability insurance, FSA or HSA, 401k with Company match, EAP, employee discounts, and a casual work environment with excellent career development opportunities.