Key Responsibilities
* Support and improve
cleanroom manufacturing processes
in line with quality, cost, and delivery goals.
* Lead and contribute to
New Product Introduction (NPI)
initiatives from concept to commercialisation.
* Implement
continuous improvement
strategies to optimise efficiency, reduce waste, and enhance process reliability.
* Prepare and execute
validation protocols
(IQ/OQ/PQ) and support equipment qualification activities.
* Develop and maintain process documentation including
work instructions, FMEAs, and process flow diagrams
.
* Investigate non-conformances and implement
CAPAs
to ensure product and process compliance.
* Collaborate cross-functionally with Quality, R&D, and Production teams to meet project timelines.
* Ensure all activities are compliant with
GMP, ISO 13485, and regulatory standards
.
Candidate Requirements
* Degree in
Engineering
, Manufacturing, Biomedical, Mechanical, or a related discipline.
* Minimum
2 years' experience
in a regulated manufacturing environment, ideally medical devices.
* Strong knowledge of
GMP, process validation
, and manufacturing best practices.
* Demonstrated experience in
problem-solving tools
(e.g., 5 Whys, Fishbone, FMEA).
* Excellent communication and
cross-functional collaboration skills
.