The ideal candidate will have a strong background in design control, quality assurance, and regulatory compliance, with the ability to work collaboratively with R&D, Engineering, Regulatory and other teams.
Adaptable and possess a deep understanding of the regulatory landscape governing medical devices, specifically experience in all phases of product life cycle (design, development, risk management, design verification, production) in adherence with ISO13485:2016, 21 CFR 820 and ISO14971.
Main Duties:
– Lead and implement design control and production processes to ensure compliance with industry standards and regulations.
– Lead proactive design assurance activities facilitating the development and release of high-quality products.
– Collaborate with cross-functional teams to integrate quality into the design and development and manufacturing process.
– Stay abreast of evolving regulatory requirements for medical devices and ensure the company's adherence to relevant standards.
– Work closely with R&D teams to understand design requirements and provide quality engineering input throughout the product development lifecycle.
– Conduct design reviews to identify and address potential quality issues early in the process.
– Responsible for reviewing, providing input and approving product development DHF documentation (design planning, inputs and outputs, design review, V&V protocol -reports, risk analysis, and design change, product transfer to operations, etc).
– Responsible for approval of product design changes and process changes (ECO).
– Participate in Design Reviews for product teams as the quality expert, reviewer, and approver.
– Implement risk management processes and methodologies in the design and development phases per ISO 14971.
– Participate in risk assessments and develop strategies to mitigate potential risks.
– Establish and maintain quality assurance procedures to ensure product quality and regulatory compliance.
– Conduct audits and assessments to identify areas for improvement and implement corrective actions.
– Conduct Failure investigations for Complaints and CAPA.
– Responsible for approval of equipment qualification and process validation documents (pFMEA, IQ, OQ, PQ, etc).
– Perform supplier audits and provided support in preparation and performance of external audits to ensure quality and regulatory requirements are met.
– Support continuous improvement activities to reduce product failure rates.
– Bachelors degree in engineering, preferably in a relevant field (e.g., Biomedical Engineering, Mechanical Engineering).
– Minimum of 3 years of experience in quality design within the medical device industry.
– Proven track record of successful collaboration with R&D, Engineering, Regulatory Affairs, and other teams.
– In-depth knowledge of design control processes and regulatory requirements (FDA, ISO, etc).
– Strong analytical and problem-solving skills.
– Excellent communication and interpersonal skills.
– Leadership skills without direct authority responsibility.
– Ability to present complex technical information in a clear and concise manner.
– Comfortable speaking in front of diverse stakeholders, including internal and external teams.
– Self-learning.
– Strong English capabilities.
– Demonstrate flexibility in adapting to changing project requirements and priorities.
– Relevant certifications in quality management or regulatory affairs advantage.
