Senior Quality Engineer

$83,600 - $167,200/Yr

Abbott Laboratories - Pomona, CA

Full-time - Mid Level

Pomona, CA

10,001+ employees

Miscellaneous Manufacturing

About the position

The Senior Quality Engineer at Abbott is responsible for overseeing quality engineering activities related to product and process changes, quality issues, and compliance. This role involves collaboration with operations for process improvement, conducting audits, and supporting the development of new products in the In-Vitro Diagnostics (IVD) medical device sector. The engineer will apply systematic problem-solving methodologies, lead process control initiatives, and ensure adherence to quality management systems and regulatory requirements.

Responsibilities

• Partner with operations to perform process audits and implement improvement initiatives.
• Identify and implement effective process control systems for product development and manufacturing.
• Act as quality assurance support for design and development of IVD medical device products.
• Assist in developing streamlined business systems to resolve quality issues.
• Apply systematic problem-solving methodologies to prioritize and resolve quality issues.
• Design and conduct experiments for process optimization and improvement.
• Collaborate with R&D, Manufacturing, Quality Control, and Applications Support to prevent non-conformities.
• Document experiment plans and results, including protocol and report writing.
• Lead risk analysis and process control monitoring of CTQ parameters.
• Implement product and process improvement methodologies such as Six Sigma and Lean Manufacturing.
• Investigate and resolve product and process non-conformances.
• Support divisional initiatives related to Quality Management Systems and regulatory requirements.
• Work with design engineering on product verification and validation.
• Perform root cause analysis of product quality issues and develop corrective actions.
• Conduct failure mode analysis on products and develop mitigations for identified failure modes.
• Coordinate development of verification and validation plans for new and existing products.
• Exhibit professional behavior that reflects positively on the company.
• Ensure compliance with established business policies and quality standards.

Requirements

• BS/BA degree in a field of science such as Chemistry, Microbiology, Biology, Biochemistry, or Engineering.
• Minimum of 5 years of experience in a quality role within the Biotechnology industry, with 3-5 years in progressively responsible positions.
• Minimum of 3 years of hands-on risk management experience.
• Minimum of 3 years of manufacturing/quality engineering experience in a regulated environment.
• Experience reviewing and approving process validations and design verifications required.
• Experience reviewing and approving Device Master Record (DMR) documents required.

Nice-to-haves

• Direct work experience in IVD, medical device/biotech, or a regulated manufacturing environment.
• Strong project management and leadership skills.
• Experience acting as Quality Lead supporting new product development.
• Hands-on experience with Design Verification, Design Validation, and Design History File (DHF).
• Process, QMS, or Supplier auditing experience.
• Lean Six Sigma (Black or Green Belt), Certified Quality Engineer, or Certified Quality Auditor.
• Demonstrated supervisory experience.
• Knowledge of IVDR, FDA QSRs, ISO 13485, and ISO 14971 standards.

Benefits

• Career development opportunities within an international company.
• Free medical coverage in the Health Investment Plan (HIP) PPO medical plan.
• Excellent retirement savings plan with high employer contribution.
• Tuition reimbursement and education benefits for obtaining a bachelor's degree.
• Recognition as a great place to work and for diversity initiatives.