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Sr. Engineer Quality Systems
Location: 6901 Preston Road Plano, TX 75024
NOTE: This role is required to work onsite five days/week.
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.
• Free medical coverage for employees* via the Health Investment Plan (HIP) PPO
• 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’s 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.
Neuromodulation
Our Neuromodulation business includes implantable devices compatible with mobile technology to help people who suffer from chronic pain and movement disorders. These non-opioid therapies allow us to provide interventional pain therapy to patients throughout the pain continuum.
What You’ll Work On
• Analyze Quality System data and present established metrics to senior and executive 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.
• Support all Divisional initiatives as identified by divisional management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements.
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 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.
• Advanced computer skills, including gap analysis and report writing skills.
• Detailed knowledge of FDA, GMP, and ISO 13485.
• Six Sigma certification (e.g., ASQ CQE, CQA or Six Sigma certification preferred).
• 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.
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.
