Quality Assurance Engineer - Medical Devices

Title: Quality Assurance Engineer - Medical Devices

Job Summary:
A fast-growing medical technology company is seeking a Quality Assurance Engineer to join their team and support the development and manufacturing of advanced medical devices. This role is ideal for someone who thrives in a documentation-heavy environment, enjoys problem-solving, and has a strong background in regulated industries. The ideal candidate will bring a passion for quality systems, a sharp analytical mindset, and a collaborative spirit.

As a Quality Assurance Engineer, you will:

• Lead and support investigations into nonconforming materials and components, including root cause analysis and corrective/preventive actions (CAPAs)

• Develop and maintain validation documentation including protocols, plans, and reports

• Participate in cross-functional meetings to support product development and design transfer

• Review and approve quality documentation such as inspection records, material reports, and manufacturing specifications

• Assist in supplier quality activities and internal audits

• Ensure compliance with applicable regulatory standards and internal procedures

• Contribute to continuous improvement initiatives and risk-based decision-making processes

What you bring to the table:

• 3-5 years of experience in a quality role within the medical device industry

• Strong understanding of CAPA processes, root cause analysis tools, and validation practices

• Familiarity with FDA 21 CFR Part 820 and ISO 13485 standards

• Excellent technical writing skills and attention to detail

• Experience with electro-mechanical assembly, cleanroom protocols, or sterilization processes is a plus

• Proficiency in Microsoft Office; experience with statistical tools like Minitab is desirable

• Must be a U.S. person (citizen or permanent resident)

Compensation & Perks:

• Base salary targeted around the mid to high $90Ks, with potential flexibility for exceptional candidates

• 10% annual performance bonus

• Opportunities for growth and visibility within a collaborative, innovation-driven team