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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