Mary Cheeramvelil Medema Email & Phone Number

Plymouth, Mi, Us

Grand Rapids, Michigan, United States

Grand Rapids Metropolitan Area

-Responsible for providing quality engineering support to operations and product development engineering to investigate, plan, and implementing product quality improvements in and/or additions to current products and manufacturing processes that directly affect safety, quality, regulatory compliance, and/or productivity.- Provide engineering expertise and leadership required to plan and implement specified projects to be completed including organizing and leading projects of various departments, planning and scheduling, coordinating resources (personnel, materials, time, money, suppliers), preparing proper documentation, etc.-Lead cause-identification and problem-resolution for various types of quality, production or service-related issues.-Monitor and control quality processes, identify issues and ensure they are resolved.-Provide quality engineering input in the design, fabrication, development, installation, validation, and qualification of equipment / processes which may include feasibility studies and/or proper documentation for justification of project and training.-Plan and implementation of quality related projects to develop, install, and qualify new processes for manufacturing new products or improving existing processes.-Assist in maintaining plant-wide calibration system and drawing control/document control system.- Maintain and support ESD program.- Plan work schedules, expenditures, attend meetings, and prepare monthly reports, Assign, delegate, and assist in completing other engineering tasks/projects.-Gather, track, and analyze production data for meetings, business plan (yields/output/efficiencies).

Ann Arbor, Mi

-Responsible for providing quality engineering support to operations and product development engineering to investigate, plan, and implementing product quality improvements in and/or additions to current products and manufacturing processes that directly affect safety, quality, regulatory compliance, and/or productivity.-Provide technical assistance to plan and implement specified projects to be completed including organizing and leading projects of various departments, planning and scheduling, coordinating resources (personnel, materials, time, money, suppliers), preparing proper documentation, etc.-Lead cause-identification and problem-resolution for various types of quality, production or service-related issues.-Provide quality engineering input in the design, fabrication, development, installation, validation, and qualification of equipment / processes which may include feasibility studies and/or proper documentation for justification of project and training.-Plan and implementation of quality related projects to develop, install, and qualify new processes for manufacturing new products or improving existing processes.-Assist in maintaining plant-wide calibration system and drawing control/document control system.-Gather, track, and analyze production data for meetings, business plan, etc. (yields/output/efficiencies).

Kalamazoo, Michigan Area

• Help to ensure compliance with GMP & ISO requirements.• Process owner for multiple risk based processes. • Experience updating, implementing and training users for new PLM system (Windchill)• Update risk documents (FMEA, PHA, Risk Management Files) • Monitor and track to closure deviations, investigations, and CAPA.• Leads and Assists customers in resolving product issues: • Complaint investigation/problem solving/Customer training • Collect, Analyze and interpret data• Problem solving efforts/ Training• Collaborate on product development• Mentors and teaches root cause analysis/Risk Management • Conducts technical review for trends, improvement ideas, risk management files-Project Management Skills • Managed top-priority projects within the company with great success. • Develop project plans including: • Task lists/ GANTT or PERT chart • Develop functional specifications that fully define project and product. • Cost/ Performance criteria/Scope • Develop and direct project resources • Periodically provide progress report to other functional areas of the company • Monitors and controls project/ Timelines • Resources/Provides development and guidance for assigned Engineer. • Manage stakeholder expectations-Managed 3 contractors • Conduct performance appraisals/feedback/timecard • Train and manage workload

-Responsible for carrying out production activities; including performing GMP cell culture of biologic products using closed-system device.-Performs all activities under GMP compliance. -Executes standard operating procedures as required.-Maintains and established in-lab systems including, but not limited to, cleaning and environmental monitoring. -Maintains and established standard operating procedures to reflect current practice. - Reviews current manufacturing operations and process, and provides technical expertise to improve procedures. -Communicates issues and recommended actions to management.-Responsible for additional duties including establishing operating specifications; leading assigned projects; participating in cross-functional teams; implementing process change orders; and training personnel in production-related procedures.-Performs additional activities as required to support Manufacturing operations.performing GMP cell culture of biologic products using closed-system technology-Involved in modification of an existing product or its presentation, or formulation of an entirely new product.-Working with cross functional teams to improve process flow and production. Analyze and design the sequence of operations and overall process flows to improve efficiencies and establish methods and processes to achieve maximum utilization of production facilities and personnel.-Participated in quality assurance process.-Participated in cross-functional teams to execute product development plan.

Fill prescriptions following doctors' instructions. Call insurance companies to verify coverage and co-pay. *Maintained pharmacy inventory, including controlled substances. *Develop good communication and customer service skills.

Took x-rays, including pan-x-rays (full mouth), following all procedures for safety. Cleaned instruments with ultrasonic machines. Ordered burrs (drills) and hand pieces. Assisted during oral surgeries. Mixed amalgams and picked shades for composite fillings. Took impressions. Performed a range of office and administrative duties. Comforted patients that were nervous and eased patients in the chair.* Moved scheduling from paper to a computer-based system.

M.S, Biomedical Engineering

Activities and Societies: Biomedical Engineering SocietyGained hands-on skills & knowledge in • Osteopedic issues and physiology •.

B.S, Biology 2009

Activities and Societies: Biology Club Chemistry Club Sigma Sigma Sigma Research AssistantGained hands-on skills & knowledge in • Anatomy.