Senior QA Lead - TPM Oversight & Compliance

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

Benefits offered by this job

Health insurance

Retirement plan

Tuition reimbursement

FreeU education benefit

Job summary

Abbott Laboratories in Austin, TX is seeking a Lead Specialist Quality Assurance to oversee quality for third-party manufacturing and TPM compliance, ensuring adherence to Abbott requirements and regulatory standards.

The role involves managing scorecards, investigations, and documentation, and collaborating across engineering, operations, regulatory, and program management while coaching teams to sustain a robust quality system.

Qualifications

• Bachelor's degree in Life Science, Engineering, or closely related discipline.
• 8+ years in Quality or related field; advanced degree may reduce experience.
• Experience with TPM oversight is a plus.

Responsibilities

• Provide quality oversight of TPM and support compliance activities.
• Manage TPM oversight activities including scorecards and SCARs.
• Ensure processes/equipment/procedures comply with regulatory, local site, Abbott requirements.
• Review documentation for accuracy, clarity, consistency, completeness and compliance.
• Plan and complete assignments with milestones in project schedules.
• Collaborate with engineering, operations, regulatory, program management and other quality teams.
• Coordinate activities across multiple project groups.
• Accept ownership and responsibility for decisions and outcomes.
• Provide guidance, coaching, and training to colleagues.

Skills

Quality oversight

Regulatory alignment

Cross-functional collaboration

Documentation review

Education

Bachelor's degree in Life Science or Engineering

Equivalents considered with experience

Job description

Abbott Laboratories in Austin, TX is seeking a Lead Specialist Quality Assurance to oversee quality for third-party manufacturing and TPM compliance, ensuring adherence to Abbott requirements and regulatory standards.

The role involves managing scorecards, investigations, and documentation, and collaborating across engineering, operations, regulatory, and program management while coaching teams to sustain a robust quality system.