QA Manager

Overall responsibility for all QA aspects of a medical device company, to ensure a valid QMS and compliance with it.

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.

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.

Qualifications

• Reports to VP Regulation and QA • Part-time or Full-time position. • Flexible hours, but significant team face-to-face collaboration activities are required. • A significant office and lab presence is required.