Design Quality Engineer

DESCRIPTION

Highly skilled and motivated Quality Design Engineer to join our dynamic team in the medical device industry. 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.

REQUIREMENTS

· Bachelor’s 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.