QA Manager

Responsibilities:

• Assume ultimate accountability for the organization’s quality management system.
• Guarantee that all products adhere to pertinent regulations, including ISO 13485, FDA 21 CFR Part 820, and EU MDR.
• Provide direction and practical assistance to the Research and Development team throughout product development and documentation (Specifications, Verification & Validation, Engineering Change Orders, Design Reviews).
• Define and implement quality control protocols for incoming materials, work in progress, and finished goods.
• Supervise risk management activities, encompassing risk identification and the implementation of mitigation plans.
• Perform critical evaluations of suppliers, conduct internal quality audits, and manage external regulatory inspections to confirm adherence to standards.
• Maintain comprehensive records of quality procedures, deviations, corrective actions, and preventive measures.
• Assist with regulatory submissions.

Reports To: VP of Clinical, Regulation and QA

Qualifications:

• Academic Background: Bachelor’s or Master’s degree in Engineering, Science, or a related discipline.
• Professional Experience: Three to five years of quality assurance experience within the medical device sector.
  • Experience with active software-based medical devices is advantageous.
  • Experience in New Product Introduction (NPI) roles is advantageous.
  • Certifications as a Quality Engineer, Quality Auditor, or similar are advantageous.
• Proficient technical writing skills in English.

Position Details:

• Part-time (60%) or full-time (100%).
• Flexible work schedule, though regular in-person collaboration with the team is necessary.