Quality Engineer I - MedTech: Validation & Compliance

BD; Salt Lake City (UT); On-site; USD 70,000 - 110,000; Full time

Job summary

BD in Salt Lake City is seeking a Quality Engineer to develop test requirements, write protocols and validate processes in a regulated medical technology environment. You will lead investigations, participate in audits, and drive risk management activities to ensure compliance with internal and external standards.

The role emphasizes collaboration with R&D, manufacturing, regulatory affairs, and quality teams to sustain product quality and patient safety.

Qualifications

• Bachelor degree in STEM required.
• Engineering degree preferred; medical device or regulated industry experience is a plus.
• Ability to navigate regulatory requirements and company procedures.

Responsibilities

• Develops test requirements to assure specifications and regulations are met.
• Writes, reviews, and approves protocols, reports, and data.
• Conducts testing outlined in protocols and test methods.
• Executes validation studies on equipment and processes; investigates complaints.
• Participates in and provides input to training on procedures and policies.
• Develops and implements Statistical Process Control.

Skills

Quality Engineering

Regulatory Compliance

Risk Management

Statistical Process Control

Audits & CAPA

Education

Bachelor's degree in STEM

Engineering degree (preferred)

Job description

BD in Salt Lake City is seeking a Quality Engineer to develop test requirements, write protocols and validate processes in a regulated medical technology environment. You will lead investigations, participate in audits, and drive risk management activities to ensure compliance with internal and external standards.

The role emphasizes collaboration with R&D, manufacturing, regulatory affairs, and quality teams to sustain product quality and patient safety.