Product Quality Engineer

BioTalent; California; On-site; USD 125,000 - 150,000; Full time

Job summary

An innovative medical device company is seeking a Product Quality Engineer to ensure regulatory compliance and quality standards for groundbreaking technologies. In this pivotal role, you will support the development lifecycle of Class II/III products, collaborating with R&D and Regulatory teams to establish design controls and risk management processes. If you are passionate about quality engineering and eager to make a significant impact in the medical field, this opportunity is for you. Join a fast-paced environment where your expertise will help bring life-changing products to market.

Qualifications

• 3+ years of quality engineering experience in the medical device industry.
• Strong understanding of design control, risk management, and V&V testing.

Responsibilities

• Provide quality engineering support throughout the product development lifecycle.
• Ensure compliance with FDA 21 CFR 820 and ISO standards.

Skills

Quality Engineering

Regulatory Compliance

Risk Management

Design Control

Verification and Validation Testing

Education

Bachelor’s degree in Engineering

Bachelor’s degree in Life Sciences

Tools

ISO 13485

FDA Regulations

Job description

This range is provided by BioTalent. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.

Base pay range

$125,000.00/yr - $150,000.00/yr

Sr. Recruitment Consultant - Medical Device | QA/RA | SaMD | SF Bay Area

A fast-growing medical device company focused on pre-market Class II/III products is seeking a Product Quality Engineer to support the development and regulatory approval of innovative medical technologies. This role will play a critical part in ensuring design, development, and risk management activities meet regulatory and quality standards before market approval.

Key Responsibilities:

• Provide quality engineering support throughout the product development lifecycle, ensuring compliance with FDA 21 CFR 820, ISO 13485, and ISO 14971.
• Work closely with R&D and Regulatory teams to develop design controls, risk management files, and verification/validation plans.
• Support the creation and execution of design verification and validation (V&V) testing.
• Assist in developing product and process risk assessments (FMEAs).
• Ensure compliance with Good Documentation Practices (GDP) and participate in internal audits and regulatory submissions.
• Collaborate with suppliers and manufacturing partners to establish incoming quality requirements for components and materials.

Qualifications:

• Bachelor’s degree in Engineering, Life Sciences, or related field.
• 3+ years of quality engineering experience in the medical device industry, preferably with pre-market products.
• Strong understanding of design control, risk management, and V&V testing.
• Experience with ISO 13485, FDA regulations, and product development processes.
• Knowledge of biocompatibility, sterilization validation, and usability engineering is a plus.

This is an exciting opportunity to be at the forefront of developing innovative medical technologies before they reach the market. If you're passionate about quality engineering in early-stage medical devices, apply today!

Seniority level

Mid-Senior level

Employment type

Full-time

Job function

Quality Assurance, Engineering, and Design

Industries

Staffing and Recruiting, Medical Equipment Manufacturing, and Biotechnology Research