In this role, you will…

• Actively participate in product development cycle by reviewing an approving System project documentation (Hardware and Software). e.g. design plan, requirement documents, specs, drawings etc.
• Participate in product risk assessments and design reviews, work closely with R&D to develop appropriate qualifications (verifications & validations) for both new design and changes to already released designs.
• Support projects in Design processes, including, but not limited to, requirements, V&V protocol and report review/approval, usability/Human factor, risk management, requirements management and trace matrix.
• Interface with R&D team, Engineering, Service and Manufacturing to drive Quality improvements.
• Work cross-functionally to implement improvements to the Product life cycle, including the establishment of risk management as an integral part of the quality management system as an overall framework for the application of appropriate engineering methods and techniques.
• Create and revise Standard Operating Procedures (SOPs) and other documentation to support the Quality System regarding software and system design.
• Support System (Hardware and software) defects process classification and resolution uncovered during development, testing and post-release.
• Provide solutions to a wide range of challenges. Work to determine and develop solutions that are imaginative, thorough, practicable, and consistent with organizational objectives.
• Lead internal audits as required by Company audit schedule.
• Follow all Quality System Practices as defined by company’s practices, policies and Standard Operating Procedures (SOPs) to ensure that FDA, ISO, EU and other global quality standards and regulations are met where applicable.

In this role, you’ll need …

• Fundamental knowledge of ISO13485:2016 and FDA requirements (e.g. CFR Part 820) EU Medical Device Directive & new MDR, ISO 14971, IEC 62366 and ISO 62304 standards for the medical devices industry
• DHF compilation, including Design Controls process and other applicable regulatory, QA and GMP aspects.
• Skilled in product risk assessment, requirements management and tracing, defect tracking, configuration management and how they are applied in the product development lifecycle.
• Good ability to comprehend multi-disciplinary systems and processes
• Effective problem solving, root-cause analytical skills to lead and influence others to drive change (cross-functionally and globally).
• Ability to work independently with minimal supervision
• Computer skills (Microsoft Word, Excel, PowerPoint)
• Working knowledge in Statistical Tools, e.g. miniTab (Measurement Systems Analysis, Process Capability and Statistical Process Control)
• Knowledge of various quality system methodologies Lean, 5 Why’s, DFMEA, PFEMA, PPAP, etc. preferred
• Strong written and verbal communication skills.
• Strong organizational skills.
• Bachelor's Degree in an engineering field or equivalent.
• At least 5 years of experience in quality engineering in the medical device industry.
• At least 2 years of leadership experience.
• Excellent written and spoken English.