Sr. Engineer II, Metrology

Quasar San Diego LLC; California; On-site; USD 120,000 - 170,000; Full time

Job summary

Quasar San Diego LLC seeks a Staff Metrology & Quality Engineer to advance metrology in a regulated medical device setting. You will develop inspection systems, program CMMs, and drive measurement accuracy while collaborating with manufacturing, R&D, and regulatory teams.

The role emphasizes quality investigations, CAPAs, and validation activities, with emphasis on GD&T, calibration, and data-driven improvement in a high-precision environment.

Qualifications

• 8+ years of metrology and/or quality engineering in a regulated manufacturing environment.
• Strong knowledge of CMM programming and advanced inspection methodologies.
• Experience with GD&T and blueprint/drawing interpretation.
• Familiarity with ISO 13485, FDA QSR, and GMP requirements.
• Data analysis and root-cause analysis skills.

Responsibilities

• Develop, validate, and maintain metrology methods and inspection systems for precision components and assemblies.
• Lead Gauge R&R/MSA, calibration strategy, and uncertainty analysis.
• Review and approve inspection plans, control plans, and quality documentation.
• Support calibration systems and traceability to national/international standards.
• Assist with risk assessments, CAPAs, and validation activities (IQ/OQ/PQ).

Skills

Metrology

Quality engineering

GD&T

Education

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

Tools

CMM programming

Vision systems

Job description

Our Culture

We strive for an inclusive company culture, where everyone feels valued, has a voice and is treated fairly, for their personal benefit, the benefit of Quasar, and the benefit of our customers and doctors using our products for patients in need.

Job Summary

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

• 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.
• 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

• 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).

Key Competencies

• Attention to detail and precision mindset.
• Strong technical communication skills.
• Cross‑functional collaboration.
• Data‑driven decision making.
• Continuous improvement orientation.
• Ability to work in fast‑paced development and manufacturing environments.

Join Our Global Team

Are you passionate about helping others? Our employees are dedicated to serving medical device customers who deliver life‑giving therapies around the world. We seek individuals who are enthusiastic, intelligent and thrive in teamwork, with a strong aspiration to pursue a fulfilling and impactful career. At Quasar, every day is a new opportunity to make a difference.

True To Quality

At Quasar, quality is more than just a priority – it is part of our culture. Our comprehensive development and manufacturing solutions for minimally invasive devices, catheters and sensors enable life‑giving therapies for patients all over the world, and we take this responsibility seriously.

We look forward to hearing from you!

Our Mission

To earn the trust of leading medical device brands as quality supply partner with minimally invasive and innovative solutions for patients globally and locally. What we make saves lives. If you share our commitment to quality and innovation, we want to hear from you.