Mary Mwaitsi

5 plus years of experience working in manufacturing/packaging and production in the medical devices and pharmaceutical industry • Experience working assembly and packaging line as well as troubleshooting of equipments • Experience with GMP and SOP and excellent communication skills • Holds a HIGH SCHOOL DIPLOMA from kabuyefwe Girls secondary school Kenya • Interview availability; Monday to Friday,anytime, also comforr=tsble with overnight interviews, with 48 hours notice • Available to start immediately, if selected.

Willing to relocate: Anywhere Authorized to work in the US for any employer

Operator II - Cretex Medical - Brooklyn Park, MN

(2024-07)

working at Cretex medical as an Operator Assembler II, my position is

• Read, understand and follow work instructions and standard work
• Understand customer needs and core business markets we serve
• Maintain an organized work area
• Complete all the work as assigned
• Support and comply with the company quality system and medical device requirements
• Inspeting parts,trim,clean and run press according to the MWI
• making sure all the devices are properly assembled according to the customers specifications
• Ensuring quality products are being produced by following work instructions and inspecting parts
• Complete assembly and secondary operations.
• Responsible for periodic checks on output
• Record number of pieces made and cycles
• Cross training in other areas of production when required.

Packaging Technician II - Upsher-Smith - Plymouth, MN

(2023-07 - 2024-02)

• Execute packaging line operations and procedures.
• Coordinate the packaging efforts for designated production lines and teams
• Complete machine set up operatios,tooling changes,adjustments and troubleshooting related to the operation of one or more packqging lines according to SOP
• Assist in maintaining line efficiencies and standards to meet quality packaging requirements and establish routine times
• Participate in the training of new members or retraining for current team members to ensure all standard operations are followed as written
• Maintain appropriate quality and production documentation
• Responsible for the review of all assigned batch records documentation to ensure error free work
• Performs general light maintenance and troubleshooting of machines and related equipment
• Review daily production compared to defined routines and identify ideas for continuous improvement
• Ensure a safe work environment and that team members are performing job duties in accordance with all safety requirements and guidelines.

Medical device specialist I - Boston Scientific - Maple Grove, MN

(2018-10 - 2023-05)

• Worked at ADSA ( Access and delivery solutions assembly) for 3years and moved to NSM( Nitinol Shape Memory) department section in 2022 February.
• Ensuring that the medical devices built is of high quality and meets the quality standards set by Boston Scientific
• Understanding and working as per quality and safety policies
• Building medical device products by following all processes as certified
• Completing other assigned work while meeting manufacturing goals and metrics
• Participating in suggesting new continous improvement plans within the team
• Good hand dexterity and ability to utilize small hand tools and equipment
• Using the microscope throughout these shift in inspecting the medical devices to make sure there is no defects
• Training and supporting newly hired medical device specialists at my department as a trainer.

High school diploma - Kabuyefwe friends girl’s secondary school - Kenya (2014-01 - 2016-11)