Quality Assurance (QA) Engineer

Position Overview

We are looking for a motivated and detail-oriented Quality Assurance (QA) Engineer to join our growing team. This is an exciting opportunity for someone looking to advance their career in quality assurance within the medical device industry.

In this role, you will support the implementation and maintenance of our Quality Management System (QMS), ensuring compliance with regulatory standards such as ISO 13485 and 21 CFR Part 820. You will work closely with cross-functional teams to help maintain quality processes, conduct inspections and contribute to continuous improvement initiatives.

This is an excellent opportunity to gain hands-on experience in a fast-paced, innovative startup environment while working on medical devices that make a real difference in patients' lives.

Key Responsibilities

• Assist in maintaining the Quality Management System (QMS) to ensure compliance with ISO 13485 and 21 CFR Part 820.
• Support quality control activities, including incoming inspections, documentation reviews, and final product release of the in market product ArtiFascia.
• Establish and maintain the Design History File (DHF) and Device Master Record (DMR) of the pre-clinical stage product (ArtiFix)
• Help monitor and track nonconformities, customer complaints, and corrective and preventive actions (CAPA).
• Participate in internal audits, ensuring corrective actions are followed up and documented properly.
• Collaborate with engineering and manufacturing teams to ensure quality requirements are met throughout the development process.
• Assist in maintaining regulatory documentation and records to support compliance efforts.
• Support supplier quality assurance activities by helping review and track supplier performance.
• Contribute to continuous improvement initiatives by identifying areas for enhancement in quality processes

Required Experience and Qualifications:

• Bachelor’s degree in engineering, biotechnology, chemistry, or a related field (or equivalent relevant experience).
• 1-3 years of experience in a medical device QA role.
• Basic knowledge of ISO 13485, 21 CFR Part 820, or quality systems in regulated industries.
• Strong attention to details, problem-solving skills, and a willingness to learn.
• Excellent written and verbal communication skills in English.
• Ability to work collaboratively in a team environment.

Preferred Qualifications:

• 1-3 years of experience with an implantable medical device regulations.
• 1-3 years of experience with biomaterial-based medical devices.
• 1-3 years of experience with validations practices.
• Familiarity with document control systems, audits or quality inspections.
• Knowledge of basic quality tools (e.g., CAPA, risk management, or nonconformance handling).

Why Join Us?

• Gain hands-on experience in the medical device industry with a focus on quality and compliance.
• Work in an innovative, fast-paced startup environment.
• Collaborate with a team dedicated to developing life-changing medical technologies.
• Grow your career with opportunities to learn and advance in QA & regulatory affairs.