Quality Engineering Lead — ISO/GMP, CAPA & CI

Merck & Co.; California (MO); On-site; USD 90,000 - 130,000; Full time

Job summary

Merck & Co. seeks a Senior Quality Engineer to lead quality investigations, CAPA activities, risk assessments, and process validation at the Rancho Dominguez facility.

You will drive supplier quality, change management, and customer complaint investigations while maintaining a robust QMS aligned with ISO 9001 and GMP principles. You will partner with engineering, manufacturing and operations to ensure products meet quality standards, regulatory requirements and customer expectations, fostering

Qualifications

• Bachelor’s degree in engineering or life sciences required.
• 7+ years in quality or manufacturing engineering in medical devices, pharma, or related field.
• Working knowledge of ISO 9001 and FDA 21 CFR 820 quality regulations.
• Strong investigative, problem-solving and data-analysis skills; excellent written/verbal communication.

Responsibilities

• Lead quality investigations and root cause analysis for manufacturing and R&D projects.
• Perform FMEA, RCA, Gauge R&R, statistics, and process control activities to prevent issues.
• Oversee metrology, calibration, and documentation for quality systems.
• Prepare quality plans, specifications, and inspection criteria for processes and materials.
• Support CAPAs, supplier quality activities, and customer complaint investigations.

Skills

Investigations tools

FMEA

RCA

Gauge R&R

Statistical analysis

Process control

CAPA

Quality audits

Documentation

Metrology & calibration

Supplier quality

Change management

Customer complaint investigations

Education

Bachelor's degree in Engineering or Life Science

Tools

MasterControl

eQMS platforms

Job description

Merck & Co. seeks a Senior Quality Engineer to lead quality investigations, CAPA activities, risk assessments, and process validation at the Rancho Dominguez facility.

You will drive supplier quality, change management, and customer complaint investigations while maintaining a robust QMS aligned with ISO 9001 and GMP principles. You will partner with engineering, manufacturing and operations to ensure products meet quality standards, regulatory requirements and customer expectations, fostering