Senior Specialist Quality

1 month ago

Buffalo Grove, United States Abbott Laboratories Full time

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. Youâll 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 bachelorâs 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.  

 

The Opportunity  

This position works out of our Buffalo Grove, IL location in the Diabetes Care division where we are focused on helping people with diabetes manage their health with life-changing products that provide accurate data to drive better-informed decisions. Weâre revolutionizing the way people monitor their glucose levels with our new sensing technology. 

What Youâll Work On 

  • Responsible for implementing and maintaining an effective Quality System at the Third Party Manufacturer (TPM).

  • Partners with TPM to develop and implement strategies for quality and compliance initiatives.

  • Independently lead groups and projects to resolve complex issues, analyze complex problems and identify their impact, establish probabilities and draw conclusions reflecting broad business needs to ensure compliance.

  • Cross-functionally lead Quality System process improvements at TPM which may include training, corrective action and preventive action (CAPA) activities, equipment maintenance, product and process planning, quality audits, validation.

  • Leads and maintains a project management office for the on-site quality function.

  • Work may require collaboration with other Division sites and/or other Abbott divisions.

  • Responsible for completing documentation in a timely manner and in accordance with business standards and quality system requirements.

  • Communicates and maintains Supplier Metrics and Supplier Scorecard to meet quality and business metrics.

  • Understand and comply with applicable EHS policies, procedures and guidelines.

  • Works under general direction; independently determines and develops approach to solutions; work is reviewed upon completion for adequacy in meeting objectives.

  • Makes timely and effective decisions related to business issues within scope of responsibility; appropriately elevates high risk issues / decisions; identifies and quantifies risks and their consequences relative to the success of a project / task; recommends appropriate action; decisions or recommendations would typically achieve departmental / project objectives.

  • Drives functional performance that ensures cross-functional standards and expectations are met.

  • Travel up to 10% of the time both domestically and internationally.

Required Qualifications 

Bachelor's Degree preferably in science, engineering or a closely related discipline or an equivalent combination of education and work experience

Minimum 5 years of relevant experience, such as Quality, Compliance, Engineering, within a regulated environment, such as medical device, diagnostics or pharmaceutical industries, to develop the competence required to meet the skills and responsibilities of the position.

Knowledge of applicable US and non-US Quality System Requirements and other relevant regulations for medical devices.

Previous experience with regulatory body. Knowledge of software regulations and compliance (21 CFR Part 11)

Knowledge of ISO 13485.

Knowledge of quality management techniques and the application and principles of quality engineering.

 

Preferred Qualifications 

Masters Degree

Strong knowledge and application of concepts, practices and procedures.  

Ability or aptitude to work on problems that are complex in scope where analysis of situations or data involves multiple competing factors.

Understanding of statistics.

Ability to form and develop interpersonal, professional relationships; display socially and professionally appropriate behavior.

Ability to work independently and in groups; ability to work cross-functionally.

Demonstrated initiative and problem-solving skills and critical-thinking skills.

Ability and aptitude to use various types of databases and other computer software.

Ability to prioritize. Strong organizational and project management skills.

Ability or aptitude to lead without direct authority.

 

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. 



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

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