Supplier Quality Engineer I at Abbott Pediatrics

Los Angeles, California, United States -

Full Time

Start Date

Immediate

Expiry Date

21 Mar, 26

Salary

114700.0

Posted On

21 Dec, 25

Experience

2 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Quality Assurance, Communication Skills, Interpersonal Skills, Regulatory Knowledge, Document Control, Supplier Management, Root Cause Analysis, Corrective Action, Performance Monitoring, Inspection Activities, FDA Regulations, ISO Standards, GMP Knowledge, Audit Execution, Collaboration, Problem Solving

Industry

Hospitals and Health Care

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 114,000 colleagues serve people in more than 160 countries. JOB DESCRIPTION: Job Title Supplier Quality Engineer I 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 Sylmar, CA location. This is an onsite role. As a global leader in Cardiac Rhythm Technologies, we focus on innovative technologies that can improve the way doctors treat people with heart arrhythmias, or irregular heartbeats. What You’ll Work On Ensures that the Division Approved Supplier List is maintained and accurate. Assesses potential new suppliers and service providers for quality and quality system capabilities through the execution of on site or desk top audits, and review of other objective evidence, as required. Communicates Division approval requirements to supplier and monitors feedback per project timelines. Performs on-site quality assessments of new suppliers, as required, and ensures appropriate corrective action response to findings. Ensures Document Control is notified of any changes to supplier statuses, as they relate to the Agile Manufacturer’s Tab. Evaluates Exception Reports (ERs) issued for nonconforming supplied material and works with the supplier on the investigation and resolution of root cause issues. Notifies suppliers of customer complaints related to failures resulting from supplied material and requires investigation and corrective action. Monitors supplier performance and reports supplier quality trend data. Participates with Incoming Quality Control on the development of incoming inspection activities or the reduction of these activities through implementation and maintenance of the Material Certification Program. Responsible for approving First Article Inspections and/or Golden Samples, as initiated by suppliers. Assists with the evaluation and approval of supplier requested changes or improvements. Complies with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments. Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors. EDUCATION AND EXPERIENCE YOU’LL BRING Required Experience: Bachelor's Degree in Engineering or Technical Field or equivalent experience or an equivalent combination of education and work experience 2 years' work-related experience Quality Assurance experience in the medical device or pharmaceutical, or other quality managed industries. Working knowledge of applicable regulations, such as FDA QSR, ISO, MDD, &/or IVDD. Detailed knowledge of FDA, GMP, ISO 13485, and ISO 14971 Solid communication and interpersonal skills. Preferred Experience: Masters Degree Preferred ASQ CQE or other certifications preferred. Please note that the salary range listed is our full grade range. We usually hire based on the mid-point. 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.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 and @AbbottGlobal. The base pay for this position is $72,100.00 – $114,700.00 In specific locations, the pay range may vary from the range posted. JOB FAMILY: Operations Quality DIVISION: CRM Cardiac Rhythm Management LOCATION: United States > Sylmar : 15900 Valley View Court ADDITIONAL LOCATIONS: WORK SHIFT: Standard TRAVEL: No 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.pdf EEO is the Law link - Espanol: http://webstorage.abbott.com/common/External/EEO_Spanish.pdf Abbott is about the power of health. For more than 135 years, Abbott has been helping people reach their potential — because better health allows people and communities to achieve more. With a diverse, global network serving customers in more than 160 countries, we create new solutions — across the spectrum of health, around the world, for all stages of life. Whether it’s next-generation diagnostics, life-changing devices, science-based nutrition, or novel reformulations, we are advancing some of the most innovative and revolutionary technologies in healthcare, helping people live their best lives through better health. The people of Abbott come to work each day with relentless energy, enthusiasm and a promise to enhance the health and well-being of millions of people. They push the boundaries to help manage and treat some of life’s greatest health challenges. We invite you to explore opportunities at Abbott, to see if your talents and career aspirations may fit with our openings. An equal opportunity employer, Abbott welcomes and encourages diversity in our workforce. Follow Us: Facebook LinkedIn YouTube Twitter

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Responsibilities

The Supplier Quality Engineer I ensures the accuracy of the Division Approved Supplier List and assesses potential new suppliers for quality capabilities. They also monitor supplier performance and communicate approval requirements while ensuring compliance with regulatory standards.