Lead Specialist Quality Assurance

Abbott • Austin, TX

2d • $99,300 - $198,700 • Onsite

About The Position

As the Lead Specialist Quality Assurance, you will be responsible for conducting and completing quality-related activities for third party manufacturing (TPM) oversight and to support a TPM in maintaining compliance with Abbott, internal, and external requirements. This position will be located at our Austin, TX Flex facility.

Requirements

• Bachelors Degree in Life Science, Engineering, or closely related discipline or an equivalent combination of education and work experience
• Minimum 8 years In Quality or related field experience; Less experience may be appropriate with advanced degree.

Nice To Haves

• Quality experience in the medical device or pharmaceutical manufacturing industries.
• History of completing successful projects and driving positive compliance outcomes.

Responsibilities

• Manage TPM oversight activities, including but not limited to scorecards, communications, SCARs, etc.
• Provide quality support and oversight of compliance readiness activities related to a TPM.
• Ensure that processes, equipment, and procedures used in the support of the Quality System are maintained in compliance with applicable regulatory, local site, and Abbott requirements.
• Review documentation (including but not limited to scorecards, communications, change control records, investigations, etc.) for accuracy, clarity, consistency, completeness, and compliance.
• Plan and complete assignments with a wide degree of difficulty while maintaining milestones established in the project schedule.
• Analyze data, procedures, and requirements to ensure quality and compliance.
• Collaborate with alternate functional teams (including but not limited to engineering, operations, regulatory, program management, and other quality teams) to ensure consideration is given to financial and business outcomes when making quality decisions.
• Coordinate activities across multiple project groups.
• Accept ownership and responsibility for decisions.
• Effectively engage with team members within Abbott and TPM teams.
• Provide guidance, coaching, and training to various functions and colleagues.

Benefits

• Career development with an international company where you can grow the career you dream of.
• Free medical coverage for employees via the Health Investment Plan (HIP) PPO
• An excellent retirement savings plan with high employer contribution
• Tuition reimbursement, the Freedom 2 Save student debt program and FreeU education benefit - an affordable and convenient path to getting a bachelor’s degree.
• A company recognized as a great place to work in dozens of countries around the world and named one of the most admired companies in the world by Fortune.
• A company that is recognized as one of the best big companies to work for as well as a best place to work for diversity, working mothers, female executives, and scientists.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior