Elisha Krajcovic
Owosso,MI
Summary
Proven Divisional Quality Engineer and Senior Segmentation Specialist at Stryker, adept in leading quality enhancement strategies and driving significant change documentation. Excelled in external audit support and risk mitigation, successfully managed global commercial holds, and spearheaded quality-focused cultural activities. Expert in quality assurance review and customer complaint handling, showcasing a blend of technical proficiency and exceptional leadership.
Overview
4
4
years of professional experience
1
1
Certification
Work History
Divisional Quality Engineer
Stryker
05.2022 - Current
- Managed 36 global commercial holds for the surgical technologies and ear, nose, and throat business unit.
- Supported rework activities in Canada and Australia, optimizing end-of-year revenue for surgical technologies and protecting $14.8M in revenue.
- Oversaw rework processes at 19 OUS distribution sites, effectively managing over 3800 Neptune rovers to avert a back order risk surpassing $10M.
- Backroom quality lead during BSI, TUV, GMED, and FDA audits for the ST and ENT business units.
- Spearheaded PMQ cultural activities, promoting quality-focused practices across the division.
- Supported various cross-functional groups by driving documentation, quality improvements, and corrective actions as a non-conformance specialist.
- Presented six product field action assessments to the Vice President of RAQAC.
Senior Segmentation Specialist
Stryker
10.2020 - 05.2022
- Ensured compliance with HIPAA guidelines to maintain patient and medical record confidentiality.
- Performed Cat-scan analysis and segmentation for 5000 patients.
- Designed 3D bone models for total knee and hip replacements using TDA software and MIMICS.
- Performed pre-operative landmarking and implant sizing for TKA (Total Knee Arthroplasty) and THA (Total Hip Arthroplasty) surgeries.
Education
Bachelor of Science - Biomedical Engineering
Lawrence Technological University
Southfield, MI05-2020
Skills
- Quality Enhancement Strategies
- Change Process Documentation
- Supplier quality management
- Waste reduction
- Quality Assurance Review
- External audit support
- Customer complaint handling
- Risk mitigation
- Failure investigation and analysis
Accomplishments
- Merit Scholarship for undergrad
Affiliations
- Culture Champ for the instruments division
- Member of Biomedical Engineering Society for Women
Certification
- Non-conformance specalist
Timeline
Divisional Quality Engineer
Stryker
05.2022 - Current
Senior Segmentation Specialist
Stryker
10.2020 - 05.2022
- Non-conformance specalist
Bachelor of Science - Biomedical Engineering
Lawrence Technological University
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