efficiencies, and create a safer environment for patients. Responsibilities: The Senior Quality Assurance Engineer shall provide leadership and support for QMS performance in many facets of business operations: Design Control - To ensure the release of safe, effective and compliant medical devices, the Sr. Quality Assurance Engineer shall provide Quality System Design Control mentoring to ensure product design teams … completed in a timely manner, performed and documented correctly, and readily offers guidance and support to ensure Quality System compliance. The Sr. Quality Assurance Engineer shall review all Engineering Change Orders and proposed changes or improvements to ensure sound engineering practice, effective and adequate design, product safety, and Quality System compliance. The Sr. Quality Assurance Engineer shall ensure that … product Design Change activities move ahead in a timely and effective manner. Manufacturing - The Sr. Quality Assurance Engineer shall monitor and ensure efficient and effective product manufacturing processes, facilitating adequate manufacturing work instructions, material control, nonconforming material handling, inspection, and finished goods handling. Material Review Board - The Sr. Quality Assurance Engineer shall facilitate efficient and effective processing of More ❯
customer contract terms and conditions Reviewing agreements such Confidentiality Agreements and providing guidance on software licencing terms and conditions Delivering commercial support and contract administration across projects, including managing changecontrol, tracking performance against contractual obligations, and mitigating commercial risks Attending and participating in customer meetings Contributing to customer proposal generation and coordinating required internal approvals Ensuring compliance … willingly share your knowledge and support with others You can influence your stakeholders and provide constructive and positive feedback to individuals and teams. You are adaptable and open to change and you're comfortable in a fast-paced, evolving environment Please note that due to the nature of this role it will require some travel within and out with More ❯
to transforming healthcare through continuous innovation. Our scalable solutions deliver critical patient data across local and remote systems, empowering better decisions, improving efficiency, and enhancing patient safety. Responsibilities Design Control & Product Development Mentor design teams on Design Controls, Risk Management, and Electrical Safety. Review Engineering Change Orders for sound engineering practices and compliance. Support technical documentation including Essential … improvements. Post-Market Surveillance & Service Monitor product performance and service documentation. Escalate and address defects, assess trends, and identify improvement opportunities. Quality System Administration Lead internal audits, CAPA, process changecontrol, and supplier quality activities. Maintain compliance with ISO 13485, MDR/MDD, MDSAP, and other global standards. Support regulatory filings including 510(k), CE Mark, and IDE … in Quality or Engineering roles. 5+ years in medical device regulatory and QMS environments. Experience with SaMD or embedded software in medical devices. Strong knowledge of technical documentation and change control. Proficient in statistical analysis and risk-based QMS activities. Excellent communication skills and a proactive, organized approach. More ❯
