Quality Engineer

Job Title: Quality Engineer II

Location: St. Louis, Missouri (On-Site Position)

About Hobson Associates’ Client:

Our client is a privately held, fast-growing medical device company headquartered in St. Louis, Missouri. Since receiving FDA clearance in 2016, Hobson’s client has been dedicated to advancing regenerative medicine through our portfolio of synthetic biomaterial products. With over 130 employees, our team is pioneering the industry’s first fully synthetic biodegradable scalpel for surgical wound management and driving rapid growth in both revenue and team size.

We operate across two St. Louis sites (HQ and manufacturing), with a collaborative culture where everyone wears multiple hats. This is an opportunity to join a small, agile team that has doubled in size in recent years, while contributing directly to the manufacturing and production success of our FDA-cleared products.

Position Summary:

We are seeking a Quality Engineer II to join our growing quality and operations team. This role will be highly engaged in downstream quality activities, with a strong focus on batch record reviews, production support, and risk mitigation in an ISO 13485–compliant environment. You will work on-site daily in our 4,000 sq. ft. St. Louis manufacturing facility, closely collaborating with manufacturing, operations, and maintenance teams to ensure products meet the highest standards of safety, compliance, and performance.

This is an opportunity for a detail-oriented, hands-on quality professional who thrives in a fast-paced environment and wants to help scale manufacturing operations for a high-growth medical device company.

Key Responsibilities:

• Perform batch record reviews and identify errors or gaps to ensure product compliance and readiness for release.
• Collaborate with manufacturing and operations teams on day-to-day production support in an ISO 13485 environment.
• Support and execute risk assessments, mitigations, and supply chain quality investigations.
• Participate in equipment-related quality activities, working alongside maintenance on 10 key pieces of production equipment.
• Assist with downstream quality tasks, including nonconformance investigations, CAPAs, and change control.
• Contribute to electronic QMS processes, ensuring accurate and timely documentation.
• Engage with cross-functional teams (manufacturing, process development, quality consultants) to maintain compliance and continuous improvement.
• Work closely with the Director of Operations and quality team to help scale the company’s manufacturing and quality capabilities.

Qualifications:

• Bachelor’s degree in engineering, life sciences, or a related technical field.
• Past experience in quality engineering within medical devices, pharmaceuticals, or biotech.
• Solid understanding of ISO 13485, 21 CFR Part 820, and FDA quality system requirements.
• Experience with batch record review and downstream quality processes strongly preferred.
• Hands-on experience with risk management, CAPA, and production support.
• Detail-oriented mindset with strong problem-solving and documentation skills.
• Ability to thrive in a small-team environment where collaboration and flexibility are key.