Senior Validation Quality Engineer at Abbott Laboratories

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.

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.

• Employees can qualify for free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year.

• 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.

THIS IS AN ONSITE DAILY REQUIRED POSITION.

Our location in Austin, TX is currently looking for a Senior Validation Quality Engineer.

The Opportunity

This position is an onsite opportunity in the Abbott Diabetes Care Division. We are helping people with Diabetes lead healthier, happier lives.   As a global leader in diabetes care, Abbott is constantly working to deliver the highest quality products and unwavering support to our customers.  Consistent and accurate glucose monitoring is the foundation of any diabetes management plan, so we’re committed to continuous improvement in the way patients and professionals measure, track and analyze glucose levels.

What You’ll Do

As the Senior Quality Engineer, you will be responsible for performing quality oversight & approval of validations, change controls, records, & projects to ensure consistent deliver of high quality documents, processes, products, and processes.

MAIN PURPOSE OF ROLE
This position is responsible for providing quality support and oversight on product, process, and equipment related changes and implementations (validation & change control). Specifically,

• Provide quality support and oversight (approval) of process and equipment validation and change control records and activities,
• Ensure that facilities, utilities, and equipment (FUE) used in the support of the Quality System are validated and maintained in compliance with regulatory and Abbott requirements,
• Review documentation (including but not limited to validation records/reports, change control records, periodic reviews, 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 third party manufacturer (TPM) teams, and
• Provide guidance, coaching, and training to various functions and colleagues.

MAIN RESPONSIBILITIES

• Participate in the development or modification of validation packages and deliverables, including assessments, plans, requirements, and protocols.
• Report unexpected events or issues which occur during validation to project team and management.
• Apply sound, systematic problem-solving methodologies in identifying, investigating, assessing impact, and resolving unexpected events or issues which occur during validation.
• Perform quality oversight & approval of equipment, process, and validation documentation and change control records (e.g. pFMEAs, URSes protocols, reports, SOPs, work instructions, process flow diagrams, ECs, etc.)
• Review documentation for accuracy, clarity, consistency, completeness, and compliance to internal and external requirements for multiple projects
• Drive strategy of FUE & process validation for new or changing products, processes, facilities, equipment, etc.
• Ensure that appropriate procedures, controls, and recovery plans are incorporated into equipment, system, process, and/or product implementations/changes.
• Work with cross functional teams to ensure quality and compliance requirements are considered during activities (e.g., work with microbiology to ensure appropriate environmental monitoring and that microbiology requirements are considered in product and process development activities)
• Drive to meet validation schedule as aligned with project(s) goals.
• Works independently with objectives given by the Quality Manager.
• Plan and coordinate own work according to higher level project schedules.
• Support (as needed) the investigation, resolution and prevention of product and process nonconformances, CAPA investigations, or other quality system records.
• Identify areas for process improvement and provides supporting information for change, including reasons and justifications.
• Assist team members and cross functional colleagues in meeting their goals by providing coaching and mentoring as needed.
• Participate in or lead teams in supporting quality disciplines, decisions, and practices (e.g., represent the Quality function as a Core Team Member).
• Support projects and Divisional initiatives as identified by management.
• Performs other related duties and responsibilities, on occasion, as assigned.

QUALIFICATIONS
Education Level Major/Field of Study Or Education Level
Bachelor's Degree Engineering or Technical Field or an equivalent combination of education and work experience

Experience/Background Experience

Experience Details

• Minimum 5 years experience in medical device/pharmaceutical manufacturing
• Demonstrated supervisory experience preferred.
• Validation experience and demonstrated use of Quality tools/methodologies.
• Detailed knowledge of FDA, GMP, ISO 13485, and ISO 14971.
• Solid communication (written and oral) and interpersonal skills.
• Strong project management and leadership skills, including the demonstrated ability to lead multi-departmental project teams and resolve quality-related issues in a timely and effective manner
• Advanced computer skills, including statistical/data analysis and report writing skills.
• Prior medical device experience preferred.
• Experience implementing various product and process improvement methodologies (e.g., Six Sigma and Lean Manufacturing).
• Experience working in a broader enterprise/cross-division business unit model preferred.
• Ability to work in a highly matrixed and geographically diverse business environment.
• Ability to work within a team and as an individual contributor in a fast-paced, changing environment.
• Ability to leverage and/or engage others to accomplish projects.
• Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization.
• Multitasks, prioritizes and meets deadlines in timely manner.
• Strong organizational and follow-up skills, as well as attention to detail.
• Ability to maintain regular and predictable attendance.

Licenses and Certifications
License/Certification ASQ CQE or other certifications preferred

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
• Training and career development, with onboarding programs for new employees and tuition assistance
• Financial security through competitive compensation, incentives and retirement plans
• 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

Apply Now

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 and @AbbottGlobal.

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The base pay for this position is $72,700.00 – $145,300.00. In specific locations, the pay range may vary from the range posted.