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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. 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 (https://www.abbott.com/corpnewsroom/strategy-and-strength/tackling-student-debt-for-our-employees.html) student debt program and FreeU (https://www.abbott.com/corpnewsroom/strategy-and-strength/college-degree-for-free-its-possible-with-freeu.html) 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.

The Opportunity

As a Section Manager,QA, you will be at the forefront of ensuring excellence in our Quality Management Systems. This role is pivotal in maintaining our commitment to quality and regulatory compliance, and in driving the continuous enhancement of our products and processes. Your role involves:

• Conducting thorough investigations, audits, and analyses to enhance our processes.

• Spearheading continuous improvement initiatives tailored to our design control system.

• Writing, revising, and updating Quality Assurance (QA) procedures when necessary.

• Upholding strict adherence to Abbott Diabetes Care’s Quality Management policies, as well as all relevant regulatory and corporate standards, including ISO 9001/13485, FDA 21 CFR part 820, and IVD/MDD directives.

• Acting as the go-to Quality Assurance representative for each assigned Product Development Team.

• Integrating quality functions into Project Teams at strategic points and ensuring their presence during Phase Reviews.

• Crafting and executing a Quality Plan for each new product development endeavor, guaranteeing a seamless flow of requirements from the Design History File (DHF) to the Device Master Record (DMR) to the Device History Record (DHR).

• Assessing complaints, Corrective and Preventive Actions (CAPAs), and findings from both internal and customer audits to recommend appropriate actions.

• Reporting on the progress and challenges of design control-related projects to senior management.

• Formulating and enforcing policies for Verification and Validation, including maintaining the site’s Validation Master Plans.

• Endorsing validation protocols and reports after thorough review.

• Fostering and sustaining productive relationships across various departments, including Research & Development (R&D), Engineering, Manufacturing, Operations, Quality Control, and Regulatory Affairs.

What You'll Work On

• Actively engage Operations and Engineering to implement design control project deliverables.

• Drive compliance to and Maintain DMR/DHF requirements in accordance with project time line and design control requirements.

• Responsible for the development, approval, and change control of, quality assurance procedures and design history documentation (e.g.

• Design Inputs, Design Outputs, Trace Matrix, Design Verification/Validation, Change Impact Assessments, Quality Plans, Work Instructions, Protocols, Reports, FMEAs, etc.).

• Collect and analyzes quality information/data from various quality systems and develop reports.

• Make data driven recommendation/decisions,

• Take appropriate action based on the trends, communicate/report activities and status as needed for senior management review. 5.Conduct or assist in systems/process/product failure mode and effects analysis and initiation of corrective and/or preventative action as it applies design control activities.

• Evaluate complaints, CAPAs.

• Internal audits findings,

• Customer audits findings and.

• Propose corrective and preventive actions.

• Analyze, monitor and report status and issues to upper management on design control related projects.

• Accountable for timeliness and effectiveness of Quality related deliverables for assigned projects.

• Accountable for directing/setting Quality strategy for new product development teams.

• Ensures project is compliant to Regulatory Compliance bodies and Abbott ADC/Corporate policies and procedures.

• Has direct impact on the success of regulatory submissions.

• This position may have 1-2 direct reports.

Required Qualifications

• BS in engineering or related field

• 7-10 years overall experience in Quality Assurance or Engineering.

• Minimum 5 years’ experience in medical device manufacturing or pharmaceutical industries,

• Minimum 3 years direct experience in Design Control.

• Working knowledge applicable regulations and standards such as FDA, QSR, ISO 13485, ISO 14197, MDD, & IVDD.

• Demonstrated written, oral, and interpersonal skills.

• Strong analytical skills, problem solving techniques and statistical application experience.

• Knowledge in the areas of Medical Device Design and Development, Design Controls, V&V activities, manufacturing practices, statistical techniques

• Knowledge of medical product quality assurance (including the requirements for test protocols and statistical techniques).

Preferred Qualifications

• Lean Six Sigma training and/or certification preferred.

• BS in Mechanical or Biomedical preferred. MBA a plus.

• Must have a demonstrated ability to solve problems with innovative solutions along with strong project management and organizational skills to deliver projects on time and on budget.

• Able to manage numerous projects/conflicting priorities, and to be flexible when priorities change.

• Experience with Class 2 and Class 3 devices, sterility assurance and packaging validation experience a plus

• Working knowledge of GCP, Clinical and Regulatory Affairs.

• Flexibility in daily activities.

• Proficient with Microsoft Suite.

Apply Now (https://www.jobs.abbott/us/en)

• 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 (http://www.abbottbenefits.com/pages/candidate.aspx)

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 and @AbbottGlobal.

The base pay for this position is $109,300.00 – $218,500.00. In specific locations, the pay range may vary from the range posted.

An Equal Opportunity Employer

Abbot welcomes and encourages diversity in our workforce.

We provide reasonable accommodation to qualified individuals with disabilities.

To request accommodation, please call 224-667-4913 or email corpjat@abbott.com