Job DescriptionÂ
Client is looking for consultants to do a deep dive of their product related documentation and processes. Dig through and analyze the document history of the device, including what they have done previously. Understand why decisions were made the way they were. How can they improve on what they have in place for future releases of the product. Read through design history file and poke holes in current documentation. How drawings are connected in process controls on manufacturing site. Inspection for components and inspection steps, risk documentation, supplier information, develop control plans/strategies to implement improvements. Address key failure points that are found though design, test, complaints, field failures etc. How did it happen and how is tied to / related. Work with supplier quality team to make changes, including design tooling and inspection.
Must have a strong medical device remediation background covering quality systems, injection molding parts, supplier controls, design testing, complaints, field failures etc. Electromechanical experience and extensive core design.
Skills:
remediation, design quality, documentation, strategy, electromechanical, 13485, 14971 and 60601
Client is looking for consultants to do a deep dive of their product related documentation and processes. Dig through and analyze the document history of the device, including what they have done previously. Understand why decisions were made the way they were. How can they improve on what they have in place for future releases of the product. Read through design history file and poke holes in current documentation. How drawings are connected in process controls on manufacturing site. Inspection for components and inspection steps, risk documentation, supplier information, develop control plans/strategies to implement improvements. Address key failure points that are found though design, test, complaints, field failures etc. How did it happen and how is tied to / related. Work with supplier quality team to make changes, including design tooling and inspection.
Must have a strong medical device remediation background covering quality systems, injection molding parts, supplier controls, design testing, complaints, field failures etc. Electromechanical experience and extensive core design.
AZ: 2 Remediation DQE (232675)
#LI-MC1
