Process Quality Engineer

We are seeking a Process Quality Engineer to join our growing QA team. This is an exciting opportunity to play a pivotal role in scaling the manufacturing of an innovative Class III medical device, driving process validation, continuous improvement, and implementing new processes from development through production.

Responsibilities

• Lead and ensure the quality of NPI and manufacturing processes.
• Lead and support Process Validation activities (IQ/OQ/PQ).
• Review and approve work instructions, assembly instructions, manufacturing specifications, validation protocols, validation reports, as well as mechanical part and assembly drawings created in SolidWorks.
• Support and manage Change Control processes.
• Provide professional guidance to R&D, Engineering, and Manufacturing teams on quality requirements, NPI, and manufacturing processes.
• Collaborate closely with R&D, Engineering, and Manufacturing teams to implement process changes, drive continuous improvements, and ensure product quality.
• Identify, lead, and implement continuous improvements in NPI and manufacturing processes while ensuring compliance with quality requirements, ISO 13485 standards, and FDA regulatory requirements.
• Provide QA oversight and support for Design Transfer / NPI activities, ensuring a smooth and compliant transfer of products from R&D to manufacturing.

QA Manager

• B.Sc. in Mechanical Engineering, Biomedical Engineering, Materials Engineering, or a related engineering discipline.
• Strong experience in mechanical product development or manufacturing.
• Minimum of 2-4 years of experience as an engineer in the Medical Device industry.
• Hands-on experience with Process Validation (IQ/OQ/PQ) and Design Transfer / NPI activities.
• Experience with Change Control processes.
• Experience working with mechanical CAD drawings.
• Ability to independently lead projects and drive cross-functional processes to completion.
• Strong self-learning capability.
• Excellent interpersonal and communication skills.