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.
The Opportunity
This position works out of our Austin, TX location in the Diabetes Care division. 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.
As the Senior Quality Engineer, you will be responsible for conducting quality-related activities to deliver consistent; high quality documents; services; products and processes.
MAIN PURPOSE OF ROLE
This position is responsible for developing and maintaining quality engineering methodologies and providing quality engineering support within new product development, manufacturing, or system/services support.
- Provide quality support of validation and change control activities, collaborating with engineering, operations, regulatory, and other quality teams.
- Ensure that facilities, utilities, and equipment (FUE) used in the support of the Quality System are developed, validated, and maintained in compliance with regulatory and Abbott requirements.
- Review documentation for accuracy, clarity, consistency, completeness, and compliance for multiple projects. Plan and complete assignments with a wide degree of difficulty.
- Analyze data, procedures, and requirements to ensure quality and compliance. Collaborate with alternate functional teams to ensure consideration is given to financial and business outcomes.
- Coordinate activities across impacted groups. Accept ownership and responsibility for decisions.
- Effectively engage with team members. Provide guidance and training to various functions and colleagues.
MAIN RESPONSIBILITIES
- Reviews pre-defined deliverables/activities as identified in the Validation Process and/or Product Quality Process/project plan or equivalent project plan.
- Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues
- Identifies areas for process improvement and provides supporting information for change, including reasons and justifications.
- Participates in the development or modification of validation packages and deliverables, including, assessments (including risk assessments, e.g., FMEAs), plans, requirements, and protocols.
- Works independently with objectives given by the Quality Manager.
- Can plan and coordinate own work according to higher level project schedules.
- Review documentation for accuracy, clarity, consistency, completeness and compliance to internal and external requirements for multiple projects, including but not limited to specifications/requirements documents, valida tion protocols & reports, trace matrices, validation events, change control packages, etc.
- Report unexpected events, issues or software bugs which occur during validation to project team and management.
- Assist team members and cross functional colleagues in meeting their goals by providing coaching and mentoring as needed.
- Drive to meet validation schedule as aligned with project(s) goals.
- Ensure that appropriate procedures, controls, and recovery plans are incorporated into equipment/systems.
- Lead the investigation, resolution and prevention of product and process nonconformances, CAPA investigations, or other quality system records
- Participate in or lead teams in supporting quality disciplines, decisions, and practices (e.g., represent the Quality function as a Core Team Member)
- Lead in the completion and maintenance of risk analysis
- 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 require ments are considered in product and process development activities)
- 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 (± 16 years) Engineering or Technical Field ☒ 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 multidepartmental 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
Apply Now
- 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.
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.