Senior Quality Systems Analyst

Description

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 115,000 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.
• 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 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.

For years, Abbott�s medical device businesses have offered technologies that are faster, more effective, and less invasive. Whether it�s glucose monitoring system, innovative therapies for treating heart disease, or products that help people with chronic pain or movement disorders, our medical device technologies are designed to help people live their lives better and healthier. Every day, our technologies help more than 10,000 people have healthier hearts, improve quality of life for thousands of people living with chronic pain and movement disorders, and liberate more than 500,000 people with diabetes from routine �ngersticks.

The Opportunity

We currently have an opportunity for a Senior Quality Systems Analyst.  This position is responsible for developing and maintaining quality systems and providing quality system support for the division (e.g. commercialized products, new product development, manufacturing, and/or system compliance).

What You�ll Work On

• Responsible for implementing and maintaining an effective Quality System.
• Collect and analyze quality data as needed for monthly metrics and data driven recommendations based on trends.
• Communicate confidently and effectively with all levels of management, peers and key stakeholders.
• Ensures compliance to ISO 13485, 21CFR 820 Quality System Regulations, and other applicable regulations and standards by providing support for audit execution, interpretation of regulations, performing gap analysis, and leading activities to implement improvements.
• Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and working with business units in resolving quality issues.
• Analyzes quality audit findings and recommends modifications in products or standards. Proactively identifies opportunities for system compliance improvement and leads activities to implement improvements to improve Quality System health.
• As appropriate, participates in or leads teams in supporting quality disciplines, decisions, and practices (e.g., represent the Quality System function as a Team Member).
• Complies with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments.  Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.
• Ensure internal activities and external partnership activities meet applicable regulations and quality standards including FDA QSR and ISO 9001/ ISO 13485
• Ensure external partnership activities meet applicable regulations and quality standards including FDA QSR and ISO 9001/ ISO 13485.
• Independently lead groups and projects to resolve complex issues. analyze complex problems and identify their impact. establish probabilities. draw conclusions reflecting broad business needs. ensure compliance.
• Cross-functionally lead Quality System process improvements which may include training, corrective action and preventive action (CAPA) activities, equipment maintenance, product and process planning, quality audits, validation.

Required Qualifications  

• Bachelor�s Degree in Engineering or technical field OR an equivalent combination of education or work experience.  
• 4 � 8 years technical experience.
• Previous Quality experience and demonstrated use of Quality tools/methodologies.
• Detailed knowledge of FDA, GMP, and ISO 13485.
• Solid communication and interpersonal skills.
• 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. 
• Advanced computer skills, including gap analysis and report writing skills.
• 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 influence as well as 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.

Preferred Qualifications  

• Master�s degree.
• Prior medical device experience with knowledge of Quality Systems and regulations (CFR820, ISO 13485, ISO 14921, ISO 9001, etc.)
• Six Sigma certification or Lean Manufacturing experience. ASQ CQE, CQA certification.
• Experience working in a broader enterprise/cross-division business unit model
• Prior audit experience.
• Strong analytical skills; awareness of Quality Management Systems/sub systems to work with the BUs on managing signals and trends. Familiarity with Power BI is highly desired.

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.

Learn more about our benefits that add real value to your life to help you live fully:  www.abbottbenefits.com

Follow your career aspirations to Abbott for diverse opportunities with a company that provides the growth and strength to build your future. 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.

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.