Senior / Staff Quality Engineer

About the Role

Our Client is seeking an experienced and highly skilled Senior Quality Engineer to join our dynamic team. This role is critical in ensuring compliance with ISO 13485 / MDSAP standards and regulatory requirements for medical devices and in-vitro diagnostics (IVD). You will play a key role in maintaining quality and performance standards across the company, working collaboratively to support design, development, manufacturing, and post-market surveillance activities.

You will be responsible for ensuring that design and development and manufacturing processes are conducted in strict compliance with our ISO 13485-certified Quality Management System (QMS). Your expertise in quality documentation, risk management, and regulatory compliance will drive excellence in project execution.

This is an exciting opportunity to make a meaningful impact in a rapidly growing and innovative medical technology company, with strong potential for career growth.

Key Responsibilities

• Develop, maintain, and own technical documentation to ensure compliance with regulatory and quality standards.
• Help to transition GRX’s current hybrid QMS to a full eQMS system – help to provide training to employees and be SME on the system.
• Support and manage design control processes for Class II/III medical devices and Class C IVDs, ensuring regulatory compliance from concept to commercialization.
• Assist with regulatory submissions and support market authorization applications.
• Provide quality oversight to third-party suppliers and contractors, ensuring adherence to design control requirements.
• Plan, conduct, and document internal audits, ensuring follow-up and resolution of any findings.
• Lead and facilitate risk management activities, ensuring all risks are identified, assessed, and mitigated in accordance with ISO 14971.
• Maintain quality controls, documentation, and processes across the business.
• Organize and manage Quality Management Review Board meetings, ensuring continuous quality improvement.
• Provide quality training and guidance to cross-functional teams.
• Lead and support investigations into non-conformities (NCs), corrective and preventive actions (CAPAs), and process improvements.

Qualifications & Experience

Essential:

• Bachelor’s degree in a relevant scientific/engineering field (or equivalent experience, minimum 5 years).
• Strong knowledge of ISO 13485/MDSAP and ISO 14971 requirements.
• Strong knowledge of other applicable regulatory standards e.g IEC61010, 60601, 62304, ISO10993, AAMI TIR:2016/(R)2021 and other applicable CLSI standards.
• Experience working within an ISO 13485 / FDA-compliant QMS.
• Solid understanding of MDR, IVDR, MDD, and IVDD regulatory frameworks.
• Expertise in design controls, risk management, validation, and CAPA/NC processes.
• Proven ability to write clear, compliant QMS documentation that aligns with both regulatory requirements and business needs.
• Excellent communication skills with the ability to influence and guide both senior and junior colleagues in best practices.

Desirable:

• Industrial experience in medical device (MD) or IVD product development.
• Certification in Lean/Six Sigma and problem-solving methodologies.
• ISO 13485:2016 Internal Auditor certification.

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