Senior Quality Professional - Validation Job
Job Description Job Attributes+
Irving, TX, US
Yes, 5 % of the Time
40 hours per week
Senior Quality Professional - Validation
Abbott is a global healthcare leader, creating breakthrough science to improve people’s health. We are always looking towards the future, anticipating changes in medical science and technology.
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 will 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
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.
This position works out of our Irving, TX location in the Transfusion Medicine Division. We are 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 ten million tests are run on Abbott’s diagnostics instruments, providing lab results for millions of people.
As a Senior Quality Professional - Validation, you will conduct quality-related activities to deliver consistent; high quality documents; services; products and processes. Supports facilities, utilities, and equipment (FUE) validation activities across multiple Transfusion Medicine (TM) Division locations collaborating with other engineering disciplines, departments and contractors.
What You will Work On
Defines project goals and milestones. Responsible for timely project completion.
Receives general direction and exercises considerable discretion to own work detail.
Provides solutions to a wide range of difficult problems. Ensures that solutions are compliant, innovative, thorough, practical and consistent with organizational objectives.
May lead FUE validation projects with cross-functional or broader scope. Interacts effectively with employees, manager, and cross-functional peers. May represent own team while on cross-functional project teams with other functional leaders. Provides guidance and trains other Professionals and Technicians. May provide oversight to one or more QA professionals and/or contractors.
Communicates confidently and effectively with management, peers, and key stakeholders.
Quality System Compliance - Demonstrates good, general understanding of the standards and regulatory bodies that regulate our industry. Ensures compliance to site level policies and procedures and demonstrates a solid understanding of Division and Corporate policies and procedures by promptly addressing noncompliance issues within Division and Corporation as appropriate.
Ensures adherence and maintains the effectiveness of the Quality System, including the Subsystems and Key processes that govern the area by promptly addressing non-compliance issues.
Makes independent decisions within defined parameters while assuring that these decisions are compliant with site level policies and procedures and are aligned with the appropriate quality system. Accepts ownership and responsibility for decisions.
Effectively engages team members and provides guidance to various functions, other professionals, and technicians.
Assists team members in meeting their goals by providing coaching and mentoring as needed. Analyzes data, procedures, and requirements with consideration given to financial and business outcomes.
Identifies areas for process improvement and provides supporting information for change, including reasons and justifications.
Reviews documentation for accuracy, clarity, consistency, completeness and compliance for multiple projects.
Ensures FUE used in the support of the Quality System are developed, validated and maintained in compliance with regulatory and corporate requirements.
Bachelor’s degree in Life Science; Engineering; or closely related discipline; OR an equivalent combination of education and work experience.
Minimum 5 years in quality or related field experience; Less experience may be appropriate with advanced degree.
Preferred experience in the medical device or pharmaceutical industry.
Has a history of completing successful projects and driving positive compliance outcomes
Knowledgeable of FDA, Quality System Regulations (QSR), Medical Device Directive, ISO guidelines and 21 CFR Part 11/Annex 11.
Knowledgeable of ALCOA+ data integrity principles.
Basic understanding of Cybersecurity principles as applied to computerized systems.
Project experience in FUE validation practices, methodologies and techniques, particularly in validation of equipment used to support medical devices manufacturing or experience leading validation teams is a plus.
Must have excellent oral and written communication skills
* Participants who complete a short wellness assessment qualify for FREE coverage in our HIP PPO medical plan. Free coverage applies in the next calendar year.
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.
The base pay for this position is $80,700.00 – $161,300.00. In specific locations, the pay range may vary from the range posted.
- quality system compliance
- engineering disciplines
- field experience
- 21 cfr part 11
- project experience
- data integrity principles
- data integrity
- medical devices
- computerized systems
- cybersecurity principles
Sorry, this job is closed.
Who We Are
PUT YOUR TALENTS TO WORK
Abbott values the leadership skills developed through military service and we have a broad range of functional areas to put your talents to work. Our organization is making a difference in the lives of the people we serve with a diverse offering of healthcare products. We have a strong veteran employee community to help with your transition from the military to the corporate world.