Senior Quality Engineer - Medical Devices Validation Lead

Biomeric; Salt Lake City (UT); On-site; USD 90,000 - 130,000; Full time

Job summary

Biomerics is seeking a Senior Quality Engineer to lead quality engineering across extrusion, metals and plastics. You will develop and maintain quality systems, procedures, and risk management in line with FDA QSRs and ISO 13485.

Responsibilities include design validation, CAPA, SCAR investigations, supplier quality, and guiding cross‑functional teams through product development and lifecycle changes. Strong analytical and communication skills are required.

Qualifications

• Minimum 5–7 years of experience in Quality Engineering in medical device manufacturing.
• Strong knowledge of process development and validation.
• Experience with FDA QSRs and ISO 13485 regulatory requirements.
• ASQ CQE/CQA certifications preferred.
• Excellent problem-solving and communication skills.

Responsibilities

• Lead Quality input in product development teams and drive quality plans.
• Develop and maintain control plans, validation protocols, and inspection procedures.
• Lead risk management activities from conception through commercialization.
• Manage CAPA, root cause investigations, and corrective actions.
• Support external audits and maintain compliance with Biomerics quality standards.
• Mentor and develop junior Quality team members.

Skills

Quality Engineering

Root Cause Analysis

CAPA

Risk Management

Statistical Methods

Documentation

Team Leadership

Education

Bachelor's degree in Engineering, Quality, or related field

Tools

Minitab

Job description

Biomerics is seeking a Senior Quality Engineer to lead quality engineering across extrusion, metals and plastics. You will develop and maintain quality systems, procedures, and risk management in line with FDA QSRs and ISO 13485.

Responsibilities include design validation, CAPA, SCAR investigations, supplier quality, and guiding cross‑functional teams through product development and lifecycle changes. Strong analytical and communication skills are required.