Quality Assurance Specialist - Sturgis, MI Plant
Sturgis, MI, United States
- Manufacturing
- Full-time
- Quality Assurance
- Quality Control
- Regulatory Compliance
The Quality Assurance Specialist at Abbott's Sturgis, MI plant ensures that all production batches meet quality and regulatory standards by identifying nonconformances and issuing shipping releases. The role involves maintaining quality system documentation, supporting regulatory compliance, participating in audits, and assisting with new product introductions. Candidates should have relevant QA or manufacturing experience, strong communication skills, and knowledge of FDA and industry regulations.
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.
Job Title: Quality Assurance Specialist
Working at Abbott
At Abbott, you can do work that matters, grow, and learn, care for yourself and your family, be your true self, and live a full life. You’ll also have access to:
- Production areas that are clean, well-lit and temperature-controlled
- Training and career development, with onboarding programs for new employees and tuition assistance
- Financial security through competitive compensation, incentives and retirement plan
- Health care and well-being programs including medical, dental, vision, wellness and occupational health programs, Medical Benefits start day 1
- Vacation – 120 hours of accrued vacation (1st yr is prorated) + vacation buy program + 3 personal days + 10 paid holidays
- Retiree Healthcare program
- Robust 401(k) retirement savings with a generous company match
- 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 stable company with a record of strong financial performance and history of being actively involved in local communities
- A company that is recognized as one of the best big companies to work for as well as the best place to work for diversity, working mothers, female executives, and scientists.
The Opportunity
This position works out of our Sturgis, MI location in the Abbott Nutrition division. Our Nutrition business develops science-based nutrition products for people of all ages, from helping babies and children grow to keeping adult bodies strong and active. Millions of people around the world count on our leading brands – including Similac®, PediaSure®, Pedialyte®, Ensure®, and Glucerna® – to help them get the nutrients they need to live their healthiest lives.
For over 70 years, Abbott’s Sturgis, Mich., has been impacting its community while producing products that provide essential nutrition to millions of families around the world. Working here, you’ll feel part of a family that is dedicated to making a difference and helping others.
What You’ll Work On
The Quality Assurance Specialist identifies all batch nonconformances for final audit/review and initiates appropriate actions for those non-conformances when needed, and issues Finished Product shipping releases in a timely manner for all conforming material goods.
- Responsible for maintaining and improving guidance documents and (Work Orders, Forms, Procedures, etc.) and supporting the overall Quality Systems Department.
- Assures that all documentation is in compliance with standards established by Abbott and other regulatory agencies before it is released for review and final approvals.
- Abilities to work with an experienced Sr. Project Leader, Quality Engineer, or Manager in identifying quality issues and approaches to their resolution.
- Addresses documentation concerns with Plant management.
- Responsible for implementing and maintaining the effectiveness of the quality system and providing support to Quality and Compliance Management to ensure Plant regulatory compliance.
- Participates in, and supports successful completion of regulatory Audits and assessments.
- Provide backup assistance in development and execution of New Product Introduction (NPI) activities including tracking and trending and communication of NPI needs and/or trends to the leadership and support staff as appropriate.
- Assist with or develop master work orders, plant procedures, and Deviations as necessary in support of plant projects, new processes, and new packages.
- You’ll also be accountable for providing excellent customer service to the production teams and meeting our compliance standards including FDA, OSHA and Abbott policies and procedures.
Required Qualifications
- Bachelor’s Degree but will consider equivalent work experience.
- Two years of relevant experience in Quality Assurance and/or Manufacturing or Engineering.
- Communicate effectively with people in Engineering, Manufacturing, Research and Development, Logistics, Material Control, and plant management.
- Knowledge of various plant processes in order to identify the causes of problems with product quality as well as potential concerns during product launches.
- Application of knowledge to solve problems with product quality is required.
- Sound technical judgment in reaching valid conclusions that will be regularly audited by Division and Corporate Auditors.
- Self-driven with the ability to work independently with little Supervision and capable of driving actions forward to meet Plant deadlines for Project Goals.
- A good working knowledge of Low Acid Food Regulations, Infant Formula Regulations, Corporate Policies, Division Policies, Plant procedures and other governmental regulations affecting the manufacturing and distribution of the products produced in the plant is required for success in this position.
Preferred Qualifications
- Degree in a Technical area such as Engineering or Food Science preferred.
In compliance with federal law, all persons hired will be required to verify identity and eligibility to work in the United States and to complete the required employment eligibility verification form upon hire. Pre-Employment Inquiries and Citizenship | U.S. Equal Employment Opportunity Commission (eeoc.gov)
* 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 and Military/Veteran friendly 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 $61,300.00 – $122,700.00. In specific locations, the pay range may vary from the range posted.
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