Quality Assurance Lead - TPM Oversight & Compliance

Abbott; Austin (TX); On-site; USD 99,000 - 199,000; Full time

Job summary

Abbott in Austin, TX is seeking a Lead Specialist Quality Assurance to oversee quality activities for third party manufacturing oversight and to support TPM compliance with Abbott requirements. This role is located at our Austin, TX Flex facility and reports into the Quality Assurance organization.

You will coordinate multidisciplinary teams, manage scorecards, change controls, investigations, and documentation to ensure regulatory alignment and robust quality systems.

Qualifications

• Bachelor's Degree in Life Science, Engineering, or closely related discipline.
• Minimum 8 years in Quality or related field experience; advanced degree may substitute.

Responsibilities

• Provide quality oversight of a TPM and support quality compliance activities.
• Manage TPM oversight activities (scorecards, communications, SCARs, etc.).
• Provide quality support and oversight of compliance readiness activities related to a TPM.
• Ensure processes, equipment, and procedures comply with regulatory Abbott requirements.
• Review documentation for accuracy, clarity, consistency, completeness, and compliance.
• Plan and complete assignments with milestones in the project schedule.
• Analyze data, procedures, and requirements to ensure quality and compliance.
• Collaborate with engineering, operations, regulatory, and other teams to consider business outcomes in quality decisions.
• Coordinate activities across multiple project groups.
• Accept ownership and responsibility for decisions.
• Engage with Abbott and TPM teams; provide guidance and training.

Education

Bachelor's Degree in Life Science or Engineering

Job description

Abbott in Austin, TX is seeking a Lead Specialist Quality Assurance to oversee quality activities for third party manufacturing oversight and to support TPM compliance with Abbott requirements. This role is located at our Austin, TX Flex facility and reports into the Quality Assurance organization.

You will coordinate multidisciplinary teams, manage scorecards, change controls, investigations, and documentation to ensure regulatory alignment and robust quality systems.