Izabela Idziak
Castlerea,County Roscommon
Summary
Accomplished Quality Engineer with extensive expertise in CAPA system utilisation, safety compliance, and quality assurance execution. Demonstrated proficiency in technical documentation review, risk management, and ISO 9001 standards. Adept at root cause analysis, non-conformity identification, and process validation. Proven track record in materials testing, GMP practices proficiency, and Six Sigma methodologies. Strong leadership skills with a customer-focused approach and exceptional attention to detail. Committed to enhancing quality management systems and driving continuous improvement through effective audit reporting and corrective action implementation.
Offering strong foundation in engineering principles with focus on quality assurance and process improvement. Knowledgeable about ISO standards, problem-solving techniques, and continuous improvement methodologies. Ready to use and develop analytical thinking, teamwork, and communication skills in Quality System Engineer role.
Overview
14
14
years of professional experience
28
28
years of post-secondary education
1
1
Certification
Work history
Quality system engineer
Harmac Medial Product
Castlerea, County Roscommon
08.2022 - Current
- Conducted internal audits to ensure compliance with ISO regulations.
- Facilitated calibration and environmental tests, ensuring process integrity.
- Administered calibration database for accurate record-keeping.
- Recorded test data using statistical quality control techniques.
- Interpreted test methods and engineering drawings to establish quality standards.
- Evaluated data, preparing reports and charts on scrap analysis and non-compliance issues.
- Coordinated equipment calibration activities, enhancing performance levels.
- Collaborated with engineering, production, and materials departments to uphold quality standards.
Quality assurance inspector
Harmac Medical Product
Castlerea, County Roscommon
01.2021 - 07.2022
- Conducted routine inspections of finished goods, ensuring high product quality.
- Identified defects and implemented corrective actions swiftly.
- Maintained consistency across products with rigorous inspection processes.
- Collaborated with team members to address quality issues effectively.
- Adhered to QA protocols, preserving company reputation.
- Reduced waste by identifying substandard items during production.
- Recommended production method changes based on defect pattern analysis.
- Logged non-conformances and executed root cause analysis to prevent recurrence.
Material handler
Harmac Medical Product
Castlerea, Co, Roscommon
10.2019 - 12.2020
- Optimised storage space through strategic placement of materials.
- Assisted with annual inventory audits to ensure data accuracy.
- Coordinated with team members to foster collaboration and teamwork.
- Identified damaged items, initiating prompt replacement or repair actions.
- Maintained updated inventory records through consistent stock checks.
- Ensured compliance with health and safety regulations for a safe working environment.
- Completed manual handling training to enhance skills and job performance.
- Performed tagging and labelling of warehouse inventory for improved organisation.
Laboratory technician
Harmac Medical Product
Castlerea, County Roscommon
05.2012 - 09.2019
- Implemented advanced software applications to enhance data reporting practices.
- Executed precise measurements with advanced tools, achieving improved accuracy of results.
- Calibrated laboratory equipment to ensure reliable outcomes in research.
- Streamlined sample collection procedures, facilitating efficient testing processes.
- Managed inventory meticulously to guarantee constant availability of essential supplies.
- Maintained strict adherence to safety protocols, ensuring a secure laboratory environment.
- Performed regular maintenance on lab equipment, minimising operational disruptions.
- Documented findings with exceptional attention to detail, enhancing report clarity.
General operator
Harmac Medical Product
Castlerea, County Roscommon
05.2011 - 05.2012
- Ensured compliance with health and safety regulations, eliminating workplace accidents.
- Maintained high-quality output through thorough inspection protocols.
- Assembled products efficiently for prompt order fulfilment.
- Fostered a positive team environment to enhance productivity levels.
- Achieved daily production goals by collaborating effectively with team members.
- Sanitised workspace consistently to uphold hygiene standards.
- Enforced quality standards by removing damaged or defective products promptly.
- Strictly adhered to established protocols to prevent workplace incidents.
Education
NFQL Level 6 - Certificate in Science in Fundamental of BioPharma and Med Technology
Shannon University
Athlone, County Westmeath 09.2019 - 06.2020
Master of Science - Chemical Technology
University, Casimir Pulaski
Radom, Poland 10.2002 - 05.2008
NVQ Level 2 - Leather Technology
Technical secondary school
Radom,Poland 09.1998 - 05.2002
Primary school
Radom, Poland 09.1990 - 06.2008
Skills
- CAPA system utilization
- Safety compliance
- Quality assurance execution
- Technical documentation review
- Customer-focused approach
- Risk management
- Quality engineering certification
- Documentation control
- ISO 9001 expertise
- Root cause analysis
- Non-conformity identification
- Data interpretation
- Process validation
- Materials testing
- Six Sigma knowledge
- GMP practices proficiency
- Quality control implementation
- Quality management systems
- Audit reporting skills
- Inspection techniques
- Cross-functional leadership
- Production monitoring strategies
- Customer relations management
- Attention to detail
- Project management expertise
- Corrective action implementation
Affiliations
- Literature
- Travelling
- Sport
Certification
Certificate of completion of calibration training
Certificate of completion of the ISO13485 course.
First aid certificate.
Languages
Polish
Fluent
English
Advanced
References
References available upon request.
Timeline
Quality system engineer
Harmac Medial Product
08.2022 - Current
Quality assurance inspector
Harmac Medical Product
01.2021 - 07.2022
Material handler
Harmac Medical Product
10.2019 - 12.2020
NFQL Level 6 - Certificate in Science in Fundamental of BioPharma and Med Technology
Shannon University
09.2019 - 06.2020
Laboratory technician
Harmac Medical Product
05.2012 - 09.2019
General operator
Harmac Medical Product
05.2011 - 05.2012
Master of Science - Chemical Technology
University, Casimir Pulaski
10.2002 - 05.2008
NVQ Level 2 - Leather Technology
Technical secondary school
09.1998 - 05.2002
Primary school
09.1990 - 06.2008
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