Quality Engineer (Medical Device)

Job overview

The Quality Engineer (Medical Device) role is an onsite position based in Houston, TX, with a salary range of $110,000 - $135,000 per year. This role supports a quality-driven manufacturer of medical devices and combination products. The role exists to ensure product quality, regulatory compliance, and operational excellence throughout the manufacturing lifecycle. By leading risk management activities and driving continuous improvement, the engineer ensures that all products meet stringent FDA and ISO standards.

What you'll do

• Provide Quality Engineering support for medical device operations.
• Ensure compliance with FDA 21 CFR Part 820 and ISO 13485.
• Lead risk management activities (FMEA).
• Oversee sterile barrier packaging and labeling control.
• Lead investigations and CAPA resolution.

What we're looking for

Skills & competencies

full-time

day shift

houston tx

quality engineer

medical device

fda

iso 13485

fmea

capa

manufacturing

$110k-$135k/yr

Work arrangement

• Weekend coverage required

Benefits & perks

• Health, dental, vision insurance, 401(k) with company contribution, paid holidays, PTO, tuition reimbursement.

Why this role

Clean, climate-controlled environment, strong emphasis on quality and safety, clear career growth.

About the employer

Jobot is hiring for this role. Industry: Surgical Appliance and Supplies Manufacturing. Sector: 33.