Principal Specialist, Software Quality AssuranceThe OpportunityThis position works out of our
Lake Forest, IL location in the
Core Lab, Diagnostics Division. 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.
As the
Principal Specialist, Software Quality Assurance, you'll be the division subject matter expert for the non-product software lifecycle, Data Integrity, and cybersecurity compliance. This position reviews and assesses software activities (e.g., suppler evaluations, lifecycle deliverable document(s), etc. to ensure that they comply with applicable procedures, standards, and regulatory requirements. Directs mulit-site and division wide software lifecycle activities to accomplish quality system objectives. Provides back-up support to the manager as needed.
What You'll Work On-
- Applies established software quality and engineering methods to the investigation and solution of software quality problems and Data Integrity.
- Leads in the creation and improvement of software development, software processes, and document processes.
- Reviews and approves software lifecycle deliverables.
- Provides regulatory interpretation/guidance division-wide and across divisions.
- Utilizes engineering and quality experience and knowledge to mentor project team and others.
- Consistently, software engineering theories, methods, and research techniques apply to the investigation and solution of complex software quality problems.
- Leads the planning and implementation of the quality aspects of software projects.
- Leads in the creation and improvement of software development, document processes, and quality operating procedures.
- Deals with high-level management and outside entities in response to quality problems, needed process improvement, and audit observations.
- Provides back-up support to the manager as needed.
- Responsible for implementing and maintaining the effectiveness of the quality system.
- Apply established software quality and engineering methods to the investigation and solution of software quality problems.
- Reviews and approves software life-cycle deliverables.
- The individual is the division subject matter expert for the non-product software life cycle, Data Integrity, and cybersecurity therefore may represent the division during internal and external inspections, such as FDA; ISO and AQR.
- Leads and support audits related to software life cycle and cybersecurity.
- Leads and support CAPAs.
Required Qualifications- Bachelors in engineering; scientific or technical discipline.
- Minimum 6 years' experience in software discipline.
- Has led a last one significant project from beginning to end.
Preferred Qualifications- Bachelors degree in engineering or computer science.
- ASQ certification related to software and/or CFR21 Part 11 compliance.
- Industry experience
- PMP
- Cybersecurity training or certification
Apply NowLearn more about our health and wellness benefits, which provide the security to help you and your family live full lives: https://abbottbenefits.com/
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.
JOB FAMILY:Operations Quality
DIVISION:TM Transfusion Medicine
LOCATION:United States > Lake Forest : CP01
ADDITIONAL LOCATIONS:WORK SHIFT:Standard
TRAVEL:Yes, 10 % of the Time
MEDICAL SURVEILLANCE:Not Applicable
SIGNIFICANT WORK ACTIVITIES:Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day), Keyboard use (greater or equal to 50% of the workday), Work requiring repeated bending, stooping, squatting or kneeling
