Senior Quality Engineer (2nd Shift)

Abbott Laboratories; Saint Paul (MN); On-site; USD 78,000 - 156,000; Full time

Job summary

Abbott Laboratories in St. Paul, MN seeks a Senior Quality Engineer (2nd shift) to support manufacturing of vascular medical devices. This is an onsite role within the Vascular division, focusing on quality engineering and issue resolution on production lines.

You will lead CAPA investigations, apply Six Sigma/Lean tools, contribute to risk management, and collaborate with design, manufacturing, and microbiology to ensure regulatory compliance.

Qualifications

• Bachelor’s Degree in Engineering or a technical field is required.
• Minimum 6+ years of related quality engineering experience.
• Knowledge of FDA, GMP, ISO 13485, ISO 14971 required; Six Sigma/Lean experience a plus.

Responsibilities

• Identify and implement process control systems to support development and ongoing manufacturing of products.
• Lead investigations, CAPAs, and resolution of nonconformances; drive root-cause analysis.
• Apply quality tools, lead risk analyses, and support product verification and validation with design and microbiology teams.

Education

Bachelor's degree in Engineering

Job description

## Senior Quality Engineer (2nd Shift)Applylocations: United States - Minnesota - New Brightontime type: Full timeposted on: Posted 8 Days Agojob requisition id: 31157067Abbott 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.## **JOB DESCRIPTION:****Job Title**Sr. Quality Engineer**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 of which you dream.* Employees can qualify for free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year.* 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.**The Opportunity**This position works out of our **St. Paul, Minnesota** location in the Vascular Division. This is a fully onsite role and will support second shift.Our medical devices 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 fingersticks.Abbott Vascular provides innovative, minimally invasive, and cost-effective products for treatment of vascular disease.The Senior Quality Engineer will be responsible for providing quality engineering support and leadership within product manufacturing, design transfer, and process/system/services in the manufacturing of Class II & III medical devices. In addition, they will provide daily quality engineering support to resolve production issues and maintaining process stability. Will support manufacturing line for any issues on manufacturing or production lines.**WHAT YOU'LL DO*** Identify and implement effective process control systems to support the development, qualification, and on-going manufacturing of products to meet or exceed internal and external requirements* Lead the investigation, resolution and prevention of product and process nonconformances and CAPAs* Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues* Assist in the development and execution of streamlined business systems which effectively identify and resolve or prevent quality issues* Lead process control and monitoring of Critical To Quality (CTQ) parameters and specifications* Lead and implement various product and process improvement methodologies (e.g., Six Sigma and Lean Manufacturing)* Participate in or lead teams in supporting quality disciplines, decisions, and practices (e.g., represent the Quality function as a Core Team Member)* Lead in the completion and maintenance of risk analysis in support of the Risk Management Files* Work with design engineering in the completion of product verification and validation* Work with microbiology to ensure appropriate environmental monitoring and that microbiology requirements are considered in product and process development activities* Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.**Required Experience:*** Bachelor’s Degree in Engineering or Technical Field; advanced degree preferred* Minimum 6+ years of related work experience or an equivalent combination of education and work experience* Engineering experience and demonstrated use of Quality tools/methodologies* Detailed knowledge of FDA, GMP, ISO 13485, and ISO 14971**Preferred Experience**:* Solid communication and interpersonal skills* Strong project management and leadership skills, including the demonstrated ability to lead multi-departmental project teams and resolve quality-related issues in a timely and effective manner* Advanced computer skills, including statistical/data analysis and technical report writing skills* Certified Quality Engineer Accreditation**Apply Now****Learn more about our health and wellness benefits, which provide the security to help you and your family live full lives:** www.abbottbenefits.comFollow 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**$78,000.00 – $156,000.00In specific locations, the pay range may vary from the range posted.## **JOB FAMILY:**Operations Quality## **DIVISION:**AVD Vascular## **LOCATION:**United States > Minnesota > St. Paul : 1225 Old Highway 8 NW## **ADDITIONAL LOCATIONS:**## **WORK SHIFT:**Standard## **TRAVEL:**Yes, 10 % of the Time## **MEDICAL SURVEILLANCE:**No## **SIGNIFICANT WORK ACTIVITIES:**Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day), Continuous standing 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.pdfEEO is the Law link - Espanol: http://webstorage.abbott.com/common/External/EEO\_Spanish.pdf