Lead Specialist Quality Assurance

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

Lead Specialist Quality Assurance

Working at Abbott

At Abbott, you can do work that matters, grow, and learn, care for yourself and family, be your true self and live a full life. You’ll also have access to:

• 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.

The Opportunity

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.

What You’ll Work On

• This position is responsible for providing quality oversight of a TPM and supporting quality compliance related activities. Specifically,
• 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, and
• Provide guidance, coaching, and training to various functions and colleagues.

Required Qualifications

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

Preferred Qualifications

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

Learn more about our health and wellness benefits, which provide the security to help you and your family live full lives: www.abbottbenefits.com

Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life. Abbott is an Equal Opportunity Employer, committed to employee diversity.

Connect with us at www.abbott.com, on Facebook at www.facebook.com/Abbott, and on Twitter @AbbottNews.

Divisional Information

Medical Devices

General Medical Devices:

Our medical devices help more than 10,000 people have healthier hearts, improve quality of life for thousands of people living with chronic pain and movement disorders, and liberate more than 500,000 people with diabetes from routine fingersticks.

CRM

As a global leader in Cardiac Rhythm Technologies, we focus on innovative technologies that can improve the way doctors treat people with heart arrhythmias or irregular heartbeats.

Diabetes

We’re focused on helping people with diabetes manage their health with life-changing products that provide accurate data to drive better-informed decisions. We’re revolutionizing the way people monitor their glucose levels with our new sensing technology.

Vascular

Abbott Vascular provides innovative, minimally invasive, and cost-effective products for the treatment of vascular disease.

Neuromodulation

Our Neuromodulation business includes implantable devices compatible with mobile technology to help people who suffer from chronic pain and movement disorders. These non-opioid therapies allow us to provide interventional pain therapy to patients throughout the pain continuum.

Structural Heart

Structural Heart Business Mission: Why We Exist

Our business purpose is to restore health and improve quality of life by designing and providing device and management solutions for treating structural heart disease.

EP

In Abbott’s Electrophysiology (EP) business, we’re advancing the treatment of heart disease through breakthrough medical technologies in atrial fibrillation, allowing people to restore their health and get on with their lives.

HF

In Abbott’s Heart Failure (HF) business, we’re developing solutions to diagnose, monitor and manage heart failure, allowing people to restore their health and get on with their lives.

Diagnostics

We’re empowering smarter medical and economic decision-making to help transform the way people manage their health at all stages of life. Every day, more than 10 million tests are run on Abbott’s diagnostics instruments, providing lab results for millions of people.

Our Point of Care diagnostic portfolio spans key health and therapeutic areas, including infectious disease, cardiometabolic, informatics, and toxicology.

Our diagnostic solutions are used in hospitals, laboratories, and clinics around the globe. The crucial information derived from our tests, instruments, and informatics systems is often the first step in patient care decision-making for hundreds of health conditions from heart attacks to blood disorders to infectious diseases and cancers.

Our rapid diagnostics solutions are helping address some of the world’s greatest healthcare challenges.

Our molecular division delivers best-in-class innovative testing solutions for people around the world to provide answers to life’s critical health decisions. We help people live full and healthy lives through our accessible, molecular-based solutions.

Nutrition

Our nutrition business develops science-based nutrition products for people of all ages, from helping babies and children grow to keeping adult bodies strong and active. Millions of people around the world count on our leading brands – including Similac®, PediaSure®, Pedialyte®, Ensure®, and Glucerna® – to help them get the nutrients they need to live their healthiest lives.

The base pay for this position is $99,300.00 – $198,700.00. In specific locations, the pay range may vary from the range posted.