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Responsibilities:
Consult with Engineers Technicians and Assemblers on processes to execute experiments and/or production runs. Support related to equipment investigations testing objective evidence of product dispositions and rework support work necessary.
Review documentation and take appropriate actions to ensure that information is appropriately catalogued and follow through to validation and qualification of equipment including transferring information to appropriate locations e.g. ECRs SOPs drawings and tooling for Engineering approval.
Utilize manufacturing software (e.g. JDE QMSPLM) to update documentation in systems.
Follow through with development of training and documentation materials based on collaboration with Engineering including identifying opportunities for modification and making recommendations enabling the seamless knowledge transfer of project and manufacturing processes; applying knowledge of processes to devise process changes in collaboration with Engineering.
May lead projects related to new equipment validation equipment investigations testing objective evidence of product dispositions and rework.
Identify potential improvement opportunities and propose solutions to optimize process and/or equipment e.g. redesign/design of basic equipment tools fixtures etc. to improve manufacturing processes for Engineering review.
Provide coaching and guidance to technicians
Additional Skills:
Excellent computer skills required including experience with MS Office Suite; ERP/MRP systems experience preferred
Ability to read comprehend write and speak English and good communication skills required
Knowledge of Health and Safety and Quality guidelines as they relate to department clean room medical device manufacturing and FDA regulations
Knowledge of Good Manufacturing and Good Documentation Practices supporting a medical device environment
Strict attention to detail
Ability to provide feedback in a professional direct and tactful manner
Must be able to work in a team environment and with minimum supervision
Proven success adhering to project schedules and managing small projects
Substantial knowledge of validation and improvement of automated equipment
Ability to troubleshoot manufacturing equipment
Knowledge of material compatibility in the proposed use environment
Education and Experience:
H.S. Diploma or equivalent
810 years of experience required
Experience in a regulated industry such as Medical Device or Pharma required
FT onsite MF contract
Full Time