Quality Assurance Compliance Specialist

4 weeks ago

San Diego, California, United States Innovive Full time

About the Role:

Innovive, a leading B2B manufacturing company serving the biomedical research industry, is seeking a highly skilled Quality Compliance Specialist to contribute to our success. As a key member of our team, you will work closely with suppliers, customers, engineering, operations, and supply chain teams to drive design and process improvements.

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.
  • Act as the primary point of contact for the Customer Service team for complaint management, leading investigations, root cause analysis, and 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.
  • Lend support and assistance to the Quality Manager with projects as needed, with additional responsibilities to be developed after 1 year of tenure.

Requirements & Skills:

  • Critical thinking and problem-solving skills.
  • Attention to detail.
  • Organizational, planning, and documentation skills.
  • Strong written and verbal communication skills.
  • Ability to take direction as well as initiative.
  • Teamwork and collaboration.

Preferred Qualifications:

  • 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.

What We Offer:

At Innovive, we offer a competitive salary, 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.

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