Senior Software Quality Engineer - Columbus, OH

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 114,000 colleagues serve people in more than 160 countries.

JOB DESCRIPTION:

Nourish the world and your career as part of the Nutrition team at Abbott.

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®, Glucerna® – to help get the nutrients they need to live their healthiest life.

WHAT WE OFFER

At Abbott, you can have a good job that can grow into a great career. We offer:

A fast-paced work environment where your safety is our priority

Production areas that are clean, well-lit and temperature-controlled

Training and career development, with onboarding programs for new employees and tuition assistance

Financial security through competitive compensation and incentives

Health care and well-being programs including medical, dental, vision, wellness and occupational health programs

Paid time off

401(k) retirement savings with a generous company match

The stability of a company with a record of strong financial performance and history of being actively involved in local communities

Learn more about our benefits that add real value to your life to help you live fully:

The Senior Software Quality Engineer will provide validation support, consultation, and training to both internal and external software development providers to assure standards are established and maintained for all phases of the computerized system lifecycle. This position will also interface with SMEs to capture and share best practices globally

WHAT YOU’LL DO

Core Job Responsibilities:

Lead software quality assurance validation and system compliance to federal regulations (e.g. 21 CFR Part 11, cGMP etc) and set overall strategic vision for sites and providers.

Maintain Quality System (QS) processes, procedures, templates and job aids and create new QS documents as needed. Provide change management.

Provide validation training on validation policies and practices.

Provide the business with consistent guidance in the creation, interpretation, and implementation of software quality systems. Assures consistent interpretation and implementation of regulatory requirements and software process improvement initiatives for the business.

Provide guidance on defining the validation & verification strategy, including risk management mitigations, verification and validation plans, protocols, and reports. Review, analyze and provide recommendations for verification and validation test data.

Provide guidance on resolving deviations associated with verification and validation activities.

Responsible for ongoing support of Validation Management System (VMS) software.

Supports site audits and support and/or lead CAPA investigations and Global Impact Assessment Reports.

Participates and advises in Validation Review Board meetings as needed.

Promote continuous process improvements by initiating and supporting process improvements to reduce software validation costs and cycle time.

Develop and track validation related metrics.

Monitors enforcement activities from Regulatory agencies and advise on any enforcements that may impact Abbott.

This position does not have direct reports but requires skills in influencing others without direct reporting relationships.

EDUCATION AND EXPERIENCE, YOU’LL BRING:

Required

B.S. degree in engineering, science, or technical related field.

5+ years of experience in design/process verification and validation in a regulated environment such as Medical Devices, Pharmaceutical Products or Food Manufacturing desired.

Knowledgeable in System Life Cycle.

Experience creating software verification and validation strategy, plans, protocols, and reports.

Understanding of engineering best practices and test methodologies.

Demonstrated capability to solve technical problems.

Strong verbal and written communication skills.

Knowledgeable in statistical rationale and sampling plans.

A high degree of interpersonal relations skills.

Able to work independently and/or function with minimal super vision. Must be able to work under pressure and stress common to office environments.

Must be able to maintain a high degree of accuracy and analytical thinking.

Must be able to deal effectively with problems and internal customers.

Must have knowledge of Microsoft Office Suite.

Misc: Travel 10%

The base pay for this position is $97,300.00 – $194,700.00

In specific locations, the pay range may vary from the range posted.

JOB FAMILY:Operations Quality

DIVISION:ANSC Nutrition Supply Chain

LOCATION:United States > Columbus : 2900 Easton Square Place

ADDITIONAL LOCATIONS:

WORK SHIFT:Standard

TRAVEL:Yes, 15 % of the Time

MEDICAL SURVEILLANCE:No

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)

Abbott is an Equal Opportunity Employer of Minorities/Women/Individuals with Disabilities/Protected Veterans.

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