Yvonne Spain
Loughrea
Summary
Accomplished manufacturing operator and Line Lead with over 20 year experience in medical device manufacturing with Covidien/Medtronic. Adaptable and perceptive with a commitment to quality and continuous process improvement. Key skills include good communication skills, and motivated. Able to work under pressure efficiently and carefully. A proven ability to work effectively on own initiative or as part of a team. Honest, Hardworking, Positive, Capable, and Knowledgeable.
Overview
32
32
years of professional experience
Work History
Line Lead
COVIDIEN/MEDTRONIC
01.2007 - 01.2024
- Ran daily production, organizing and coordinating the team to manufacture quality, cGMP compliant products
- Ensured team compliance with SOPs, EHS and cGMP, manufacturing quality product in a safe and efficient environment
- Liaised with production operators to ensure fulfilment of daily/monthly build targets
- Provided information and guidance via daily and weekly meetings and monthly cascade meetings
- Communicated management daily on previous day’s production with H&S actions and quality yields
- Part of the core team, appointed NCR Champion, identified A3 and quality circles to improve quality systems
- Engaged with schedules and planned headcount requirements for assigned areas
- Identified resources and implemented training plans on compliance, versatility and development needs
- Maintained a very high standard of housekeeping, following all environmental health and safety rules.
Production Operator
COVIDIEN/MEDTRONIC
09.2000 - 07.2007
- A Skilled operator with over 7 years of experience
- Duties included assembling medical devices following GMP, SOPs to the highest quality standards
- Worked with other team members to maintain current production including manufacturing of sub-assembly parts, assembly and packaging of the product
- Operate and maintain equipment used in the production process
- Monitor the production process and perform regular quality checks
- Follow standard operating procedure, GMP and Safety protocols
- Troubleshoot and resolve any issues that may arise during production
- Coordinate with other team members eg, Quality, Engineers to ensure smooth production flow
- Keep records of production output, downtime, and any maintenance or repairs.
Production Assistant
GREEN ISLE FOODS LTD
06.1992 - 09.2000
- Assist in setting up production equipment and machinery
- Support the assembly line, ensuring materials are replenished as needed
- Operators are fully gowned and masked to do duties include feeding batches of raw materials into machinery, assembling goods on an assembly line
- Control machinery that processes food, make sure there's a constant supply of ingredient, checking instruments like temperature gauges
- Strive for the highest quality and consistency which is why there is a focus on processes and checks at all stages.
Education
High School Diploma -
Mercy College Woodford
Woodford, Galway06-1990
Skills
- Medical Devices
- Medical Manufacturing
- Quality Assurance
- Production Cell Lead
- Lean Six Sigma
- GMP Standards
- BPCS Systems
- Agile Quality Systems
- Cross-functional Team Leadership
- Performance Management
- Training & Development
- Continuous Improvement
- Manual Handling
Professional Development
- ECDL Computer Course (2007)
- First Line in Management: NCI (2008)
- Green Belt Sigma: Medtronic (2008)
- Lean Manufacturing & 5s Training (2010)
- A3 Problem Solving: Medtronic (2011)
- Train the Trainer: Medtronic (2013)
- First Aid & Defib Training: Order of Malta (2017)
Timeline
Line Lead
COVIDIEN/MEDTRONIC
01.2007 - 01.2024
Production Operator
COVIDIEN/MEDTRONIC
09.2000 - 07.2007
Production Assistant
GREEN ISLE FOODS LTD
06.1992 - 09.2000
High School Diploma -
Mercy College Woodford
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