Abbott

Quality Assurance Supervisor

Posted on: 7 Feb 2021

Abbott Park, IL

Job 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 107,000 colleagues serve people in more than 160 countries

JOB DESCRIPTION:

ABOUT ABBOTT DIAGNOSTICS:

The key to successful treatment and full recovery is often fast, accurate diagnosis. Abbotts life-changing tests and diagnostic tools provide insights that enable smarter, faster decisions and transform the way the world is managing health.

Our pioneering technology spans the world of healthcare operations with medical diagnostic instruments, tests, automation and informatics solutions for hospitals, reference labs, blood centers, emergency departments, physician offices and clinics.

Our location in Lake County, IL currently has an opportunity for a Quality Assurance Supervisor.

WHAT YOULL DO Please Modify

As the Quality Assurance Supervisor, you will be responsible for the Product Quality Assurance (PQA) team supporting Immunoassay Third Party manufactured products , and supervising an exempt team which supports complaints, risk evaluations, risk control measures, and other post-market surveillance and communication activities. You will spend time working to grow and develop team members, monitor and respond to field performance and customer feedback, ensure full audit readiness and milestones are achieved within budget.

* Responsible for implementing and maintaining the effectiveness of the quality system; Drive proactive quality within team to ensure audit readiness
* Drives continuous improvement in compliance through the maintenance of quality policies.
* Provides direct audit support including functioning as a PQA SME with auditors, and supervises audit-support activities
* Responsible for mentoring, conducting performance reviews, creating training plans and delivering training to team members, in addition to identifying staff development needs in areas such as GMP training, technical skills, safety, performance management and best practices.
* Identifies cause-effect relationships and uses technical/quality knowledge and experiences to recommend and execute action plans.
* Responds directly to requests for information from internal quality organizations and external regulatory agencies.
* Takes action to ensure the team, department, and overall GPQA organization meets the required goals and metrics.
* Manage quality discrepancies related to process, product, and customer complaints; and develops scope, disposition, and corrective actions for prevention of future discrepancies.
* Quantifies Risk by identifying the financial, quality, regulatory, and human considerations associated with decisions.

EDUCATION AND EXPERIENCE YOULL BRING

Required

* BS or equivalent and 2-4 years of related operations experience.
* Experience should demonstrate the application of analytical and mathematical skills, and the ability to understand financial information or directly technical experience sufficient to demonstrate the knowledge typically associated with the degree and experience requirement.
* Knowledge of regulations and standards affecting IVDs and Biologics

Preferred

* Degree in Medical Technology, Engineering, or Sciences
* Experience in healthcare or healthcare industry, especially in the clinical laboratory
* Experience in customer support, complaint handling, and/or risk
* Ability to motivate and influence a team
* Effective verbal and written communication skills with the ability to summarize and present on complex technical topics
* Strong interpersonal skills and decision-making ability
* Ability to train, organize and supervise the efforts of a work group.
* Demonstrated capability of driving change

WHAT WE OFFER

At Abbott, you can have a good job that can grow into a great career. We offer:

* Training and career development, with onboarding programs for new employees and tuition assistance
* Financial security through competitive compensation, incentives and retirement plans
* Health care and well-being programs including medical, dental, vision, wellness and occupational health programs
* Paid time off
* 401(k) retirement savings with a generous company match
* The stability of a company with a record of strong financial performance and history of being actively involved in local communities

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.

JOB FAMILY:

Operations Quality

DIVISION:

ADD Diagnostics

LOCATION:

United States > Abbott Park : AP08B Floor-1

ADDITIONAL LOCATIONS:

WORK SHIFT:

Standard

TRAVEL:

Yes, 5 % of the Time

MEDICAL SURVEILLANCE:

No

SIGNIFICANT WORK ACTIVITIES:

Continuous sitting for prolonged periods (more than 2 consecutive hours 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

Lake Bluff, IL

Abbott Laboratories discovers, develops, manufactures, and sells health care products worldwide. The company’s Established Pharmaceutical Products segment offers branded generic pharmaceuticals for the treatment of pancreatic exocrine insufficiency; irritable bowel syndrome or biliary spasm; intrahepatic cholestasis or depressive symptom; gynecological disorder; hormone replacement therapy; dyslipidemia; hypertension; hypothyroidism; Ménière's disease and vestibular vertigo; pain, fever, and inflammation; migraine; and anti-infective clarithromycin, as well as provides influenza vaccines and products that regulate physiological rhythm of the colon.

Its Diagnostic Products segment offers core laboratory systems in the areas of immunoassay, clinical chemistry, hematology, and transfusion; molecular diagnostics systems that automates the extraction, purification, and preparation of DNA and RNA from patient samples, as well as detects and measures infectious agents; cartridges for blood analysis; rapid diagnostics systems for infectious diseases; molecular point-of-care care testing for HIV, influenza A and B, RSV, and strep A; cardiometabolic test systems; drug and alcohol test systems, as well as remote patient monitoring and consumer self-test systems; and informatics and automation solutions for use in laboratories. The company’s Nutritional Products segment provides pediatric and adult nutritional products.

Its Cardiovascular and Neuromodulation Products segment offers rhythm management, electrophysiology, heart failure, vascular, and structural heart devices for the treatment of cardiovascular diseases, as well as neuromodulation devices for the management of chronic pain and movement disorders.

The company also provides glucose and blood glucose monitoring systems, including test strips, sensors, data management decision software, and accessories for people with diabetes. The company was founded in 1888 and is headquartered in Abbott Park, Illinois.