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.
What you'll do
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.
Reports to
QA Manager
Requirements
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.