Assist in maintaining the Quality Management system (QMS) to ensure compliance with ISO 13485 and 21 CFR Part 820.
Lead quality control activities, including incoming inspections, documentation writing and reviews, and final product release.
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 writing and 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.
Requirements: Bachelors degree in engineering, biotechnology, chemistry, or a related field (or equivalent relevant experience).
5-7 years of experience in Quality Assurance.
Knowledge of ISO 13485, 21 CFR Part 820, or quality systems in regulated industries.
Experienced in writing and maintaining quality documents.
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:
3+ years of experience in implantable medical device regulations.
3+ years of experience in biomaterial-based medical devices.
3+ years of experience in validations practices.
Familiarity with document control systems, audits or quality inspections. Knowledge of basic quality tools (e.g., CAPA, risk management, or nonconformance handling).
This position is open to all candidates.