Senior Quality Engineer (Complaint Handling)

Abbott; Pomona (CA); Vor Ort; USD 90.000 - 180.000; Vollzeit

Zusammenfassung

Abbott in Pomona, CA is seeking a Senior Supplier Quality Engineer (Complaint Handling) to lead quality engineering activities addressing product/process issues and complaint handling. The role partners with operations to drive improvement and ensures regulatory compliance across the product lifecycle.

The ideal candidate will manage complaint investigations, CAPA, and risk management, and support design control activities.

Qualifikationen

• Bachelor in science or engineering field; 5+ years in a quality role in biotechnology with 3–5 years of progressive responsibility.

Aufgaben

• Drive continuous process improvement with Operations to improve processes and resolve issues.
• Administer complaint handling and investigate inquiries; support CAPA and nonconformance.
• Ensure compliance with QMS, ISO, FDA and GMP; support audits and validation activities.
• Collaborate with R&D, Manufacturing, QC, and Design Engineering to address quality challenges.

Kenntnisse

Quality engineering

CAPA

Root cause analysis

Project management

Leadership

Ausbildung

Bachelors in science/engineering

Tools

QMS software

Risk management (FMEA)

Jobbeschreibung

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 122,000 colleagues serve people in more than 160 countries.

JOB DESCRIPTION: 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:

The Opportunity

This position works out of our Pomona, CA location in the Toxicology Business Unit, Rapid and Molecular Diagnostics Division. We’re empowering smarter medical and economic decision-making to help transform the way people manage their health at all stages of life. Every day, more than 10 million tests are run on Abbott’s diagnostics instruments, providing lab results for millions of people.

Senior Supplier Quality Engineer (Complaint Handling)

The Senior Supplier Quality Engineer (Complaint Handling) will be responsible for quality engineering activities that address product/process changes, product/process quality issues and resolution, complaint handling, and compliance issues. This person will partner with operations for process improvement and continuous improvement initiatives and will engage in complaint handling to address potential customer concerns. This person may be involved in the development of new products and as such would support design control activities.

What You’ll Work On

Drive continuous process improvement by partnering with Operations to improve processes and resolve issues. Support the development, implementation, and monitoring of process control systems and Critical-to-Quality (CTQ) measures to ensure products consistently meet internal, customer, and regulatory requirements; this includes participation with non-conformance, CAPA, and complaints. Administer Enterprise software for complaint handling; lodge and investigate customer inquiries and complaints. Adhere to regulatory compliance requirements for issue reporting to regulatory bodies. Provide Quality Assurance support for IVD medical device development and lifecycle management, ensuring compliance with design controls, risk management, quality planning, verification, validation, and change control processes. Support risk management activities, including risk assessments, FMEA, and failure mode analysis, to identify potential issues and implement effective mitigation strategies. Investigate, resolve, and prevent product and process nonconformances through structured problem-solving, root cause analysis, CAPA, and quality improvement methodologies. Administer resolution of non-conformances and CAPA in Enterprise applications in conjunction with key stakeholders. Collaborate cross-functionally with R&D, Manufacturing, Quality Control, Applications Support, and Design Engineering teams to proactively address quality challenges and drive effective solutions. Manage multiple projects and priorities while providing leadership, coaching, and mentorship to support team development and successful project execution. Ensure compliance with Quality Management Systems (QMS), ISO, FDA, EMS, and company policies by supporting audits, regulatory requirements, documentation, validation activities, and continuous quality system improvement.

Required Qualifications

Bachelors in fields of science such as Chemistry, Microbiology, Biology, Biochemistry, or Engineering. Minimum 5 years experience in a quality role within the biotechnology industry with 3-5 years of progressive responsible positions.

Preferred Qualifications

Direct work experience in IVD or medical device/biotech or regulated manufacturing environment. ASQ CQE or other certifications preferred. 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. Experience including new product development, design transfer, validation, QMS, and Supplier Audit experience is desired. Experience with reagent, ELISA, HEIA manufacturing desired. Lean Six Sigma (Black or Green Belt), Certified Quality Engineer, Certified Quality Auditor desired. Demonstrated supervisory experience preferred. Knowledge of IVDR in EU, FDA QSRs, ISO 13485:2016, ISO 14971:2012 standards and HACCP, GMP, GLP and GDP requirements.

Job Family

Operations Quality

DIVISION

TOX ARDx Toxicology

LOCATION

United States > Pomona : 829 Towne Center Drive

Additional Details

Work Shift: Standard. Travel: Yes, 25 % of the Time. Medical Surveillance: Not Applicable.

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), Keyboard use (greater or equal to 50% of the workday), Routine work with chemicals

Equal Opportunity Statements

Abbott is an Equal Opportunity Employer, committed to employee diversity.

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

An equal opportunity employer, Abbott welcomes and encourages diversity in our workforce.

Base Pay

The base pay for this position is $90,000.00 – $180,000.00. In specific locations, the pay range may vary from the range posted.

Company Culture

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.

Contact

Connect with us at abbott.com, on LinkedIn at https://www.linkedin.com/company/abbott-/, and on Facebook at https://www.facebook.com/AbbottCareers.