Quality System Engineer

Working at Abbott At Abbott, you can do work that matters, grow, and learn, care for yourself and your 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 a 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 worldwide 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 the best place to work for diversity, working mothers, female executives, and scientists. What You'll Work On Analyze Quality System data and present established metrics to management. Investigates and resolves quality system corrective actions and preventive actions.

Support internal and external audits. Works with cross functional teams to develop sound quality improvement plans that effectively consider the impact of change(s) and the actions required for implementation. Ensures compliance to ISO 13485, 21CFR 820 Quality System Regulations, and other applicable regulations and standards by providing support for interpretation of regulations, performing gap analysis, and leading activities to implement improvements.

Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues. As appropriate, utilizes Lean, Six Sigma, and other quality tools to implement process improvements to enhance product quality and reduce process variance by identifying improvement opportunities in divisional quality system compliance, device, and process.

Analyzes quality audit findings and recommends modifications in products and processes. Proactively identifies opportunities for system compliance improvement and leads activities to implement improvements. Required Qualifications Bachelor's Degree in Engineering or Technical Degree or an equivalent combination of education and work experience.

3+ years' experience in the ownership of CAPA process, to include conducting root cause investigations and developing action plans/effectiveness checks.

Preferred Qualifications Demonstrated and impactful project management and leadership skills, including the demonstrated ability to lead multi-departmental project teams and resolve quality system-related issues in a timely and effective manner. Multitasks, prioritizes, and meets deadlines in timely manner. Strong organizational and follow-up skills, as well as attention to detail.

Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization. Experience working in a broader enterprise/cross-division business unit model preferred. Ability to work within a team and as an individual contributor in a fast-paced, changing environment.

Advanced computer skills, including gap analysis and report writing skills. Detailed knowledge of FDA, GMP, and ISO 13485. 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. The base pay for this position is $68,000.00 - $136,000.00 In specific locations, the pay range may vary from the range posted.

JOB FAMILY: Operations Quality DIVISION: NM Neuromodulation LOCATION: United States > Texas > Plano : 6901 Preston Road ADDITIONAL LOCATIONS: WORK SHIFT: Standard TRAVEL: Not specified MEDICAL SURVEILLANCE: Not Applicable SIGNIFICANT WORK ACTIVITIES: Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day), Continuous standing for prolonged periods (more than 2 consecutive hours in an 8 hour day), Continuous walking for prolonged periods (more than 2 hours at a time in an 8 hour day) Abbott is an Equal Opportunity Employer of Minorities/Women/Individuals with Disabilities/Protected Veterans.

EEO is the Law link - English: http://webstorage.abbott.com/common/External/EEO_English.pdf EEO is the Law link - Espanol: http://webstorage.abbott.com/common/External/EEO_Spanish.pdf Abbott is about the power of health. For more than 135 years, Abbott has been helping people reach their potential - because better health allows people and communities to achieve more.

With a diverse, global network serving customers in more than 160 countries, we create new solutions - across the spectrum of health, around the world, for all stages of life. Whether it's next-generation diagnostics, life-changing devices, science-based nutrition, or novel reformulations, we are advancing some of the most innovative and revolutionary technologies in healthcare, helping people live their best lives through better health.

The people of Abbott come to work each day with relentless energy, enthusiasm and a promise to enhance the health and well-being of millions of people. They push the boundaries to help manage and treat some of life's greatest health challenges. We invite you to explore opportunities at Abbott, to see if your talents and career aspirations may fit with our openings.

An equal opportunity employer, Abbott welcomes and encourages diversity in our workforce. Follow Us: Facebook LinkedIn YouTube Twitter