Sr. Engineer II, Metrology

Quasar Medical | Medical Device Manufacturer; Carlsbad (CA); On-site; USD 140,000 - 190,000; Full time

Job summary

Quasar Medical in Carlsbad, CA is seeking a Staff Metrology & Quality Engineer to support precision manufacturing in a regulated medical device environment. You will develop metrology systems, ensure measurement accuracy, and serve as a technical authority bridging metrology with quality engineering.

The ideal candidate has a strong background in CMM programming, GD&T, MSA and CAPA, and will collaborate with Manufacturing, R&D Operations, Supplier Quality, and Regulatory Affairs to drive

Qualifications

• Bachelor’s degree in Industrial, Manufacturing, Mechanical Engineering, or related technical discipline.
• 8+ years of experience in metrology and/or quality engineering in a regulated manufacturing environment.
• Experience with CMM programming and advanced inspection methodologies.
• Strong understanding of Geometric Dimensioning and Tolerancing (GD&T) and blueprint/drawing interpretation.
• Experience performing MSA, Gauge R&R, Cp/Cpk, and statistical analysis.
• Working knowledge of ISO 13485, FDA Quality System Regulation, and GMP requirements.
• Strong data analysis, problem-solving and root cause analysis skills.

Responsibilities

• Develop, validate, and maintain metrology methods and inspection systems for precision components and assemblies.
• Program and optimize CMMs, vision systems, laser measurement systems, optical comparators, and other advanced inspection equipment. Support implementation of automated and in-process inspection technologies.
• Manage calibration systems and ensure traceability to national/international standards.
• Establish inspection methodologies for complex geometries and tight-tolerance components and develop procedures.
• Lead Gauge R&R/Measurement System Analysis (MSA), calibration strategy, uncertainty analysis, and capability studies.
• Analyze quality data and identify trends to drive continuous improvement initiatives.
• Partner with Manufacturing Engineering and Operations to improve process capability and yield.
• Assist with risk assessments and statistical analysis related to product quality.

Skills

CMM programming

GD&T

Metrology

Quality engineering

Gauge R&R

Statistical analysis

Regulatory compliance

Root cause analysis

Education

Bachelor’s degree in Industrial, Manufacturing, Mechanical Engineering, or related technical discipline

Tools

CMM software

Vision systems

Minitab/JMP

Job description

We are seeking a highly motivated Staff Metrology & Quality Engineer to support precision manufacturing and inspection operations within a regulated medical device environment. This role is responsible for developing and maintaining metrology systems, driving measurement accuracy and capability, supporting quality investigations, and ensuring compliance with applicable regulatory and quality standards. The Staff Metrology & Quality Engineer serves as a technical authority bridging precision measurement capability with quality engineering methodology.

The ideal candidate combines strong analytical and technical measurement expertise with hands‑on quality engineering experience in high‑precision manufacturing environments.

This engineer will work closely with customers, manufacturing/ process engineers, R&D Operations, Supplier Quality & Regulatory Affairs.

Key Responsibilities:

Metrology & Measurement Systems

• Develop, validate, and maintain metrology methods and inspection systems for precision components and assemblies
• Program and optimize CMMs, vision systems, laser measurement systems, optical comparators, and other advanced inspection equipment. Support implementation of automated and in‑process inspection technologies
• Manage calibration systems and ensure traceability to national/international standards
• Establish inspection methodologies for complex geometries and tight‑tolerance components and develop procedures
• Lead Gauge R&R/Measurement System Analysis (MSA), calibration strategy, uncertainty analysis, and capability studies
• Analyze quality data and identify trends to drive continuous improvement initiatives
• Partner with Manufacturing Engineering and Operations to improve process capability and yield
• Assist with risk assessments and statistical analysis related to product quality

Quality Engineering

• Support nonconformance investigations, CAPAs, root cause analysis, and corrective actions
• Support validation activities including IQ/OQ/PQ and process qualification. Maintain documentation in accordance with design control and document control requirements
• Review and approve inspection plans, control plans, SOPs, and quality documentation
• Participate in supplier quality activities including qualification, audits, and incoming inspection strategies
• Support internal and external audits

Skills and Knowledge Required:

Required

• Bachelor’s degree in Industrial, Manufacturing, Mechanical Engineering, or related technical discipline
• 8+ years of experience in metrology and/or quality engineering in a regulated manufacturing environment
• Experience with CMM programming and advanced inspection methodologies
• Strong understanding of Geometric Dimensioning and Tolerancing (GD&T) and blueprint/drawing interpretation
• Experience performing MSA, Gauge R&R, Cp/Cpk, and statistical analysis
• Working knowledge of ISO 13485, FDA Quality System Regulation, and GMP requirements
• Strong data analysis, problem‑solving and root cause analysis skills

Preferred

• Experience in medical device manufacturing
• Experience with precision components or Nitinol components
• Familiarity with MicroVu, Keyence, or similar metrology platforms
• ASQ Certified Quality Engineer (CQE) certification or Certified Metrology Technician (CMT)
• Experience with automated inspection systems and data analytics tools (Minitab, JMP or equivalent)
• Attention to detail and precision mindset
• Strong technical communication skills
• Cross-functional collaboration

Ability to work in fast‑paced development and manufacturing environments