SR QLTY & RELIABILITY ENGINEER
Job Overview
What your background should look like:
Temporary SR QLTY & RELIABILITY ENGINEER – Maternity Leave Cover
Experience/Qualification:
- Bachelor’s or master's degree with a scientific or engineering emphasis.
- 5 years’ related experience working at a progressively responsible level.
- Strong working knowledge of regional and international quality system requirements including 21CFR 820 and ISO 13485.
- Deep understanding of quality system requirements and how each quality system element connects.
- Strong analytical and problem-solving skills as well as solid business acumen is essential
- Well organized with a strong ability to prioritize tasks and work on own initiative through independent judgement.
- Adaptable, flexible and responsive to "think outside the box", envision future state and help guide site level teams in implementing improvement changes.
- Ability to build working relationships and effectively interact collaboratively with technical and non-technical peers on solutions and issues.
- Good written and verbal communication skills.
- Comfortable speaking and presenting to leadership.
- Fluent in English, Spanish is an advantage
- Creative and innovative thinking skills
Job Responsibilities:
- Proactively engages cross-functionally and with cross-site experts to drive best practice eQMS processes across Global Medical.
- Drives site leadership in mindset changes required to successfully transition to a “One Global” QMS strategy.
- Evaluates site proposals for changes to the eQMS template, makes recommendations to site management for adoption or rejection by identifying potential challenges and defining improvement suggestions.
- Works with Global QS leads / PUB leads to agree priority projects to further align TE Medicals expectations of harmonization of QMS processes.
- Drives harmonization and continuous improvement Global projects; works with sites to develop implementation plans, ensure site activities/ project deliverables are achieve as planned, monitor subsequent implementation phase for effectiveness.
- Manages eQMS System integration and harmonization activities for new sites and businesses.
- Works with IS Technical leads / external consultants on technical solutions required to drive fixes to the Global electronic QM system (SmartSolve).
- Acts as functional SME for global QS, supporting in building functional QS and eQMS knowledge by identification of training needs with plant level SME’s.
- Assists in ensuring all sites are “audit ready”.
- Applies sound, systematic problem-solving methodologies in identifying, prioritizing, and resolving issues.
- This role reports directly to the Global Quality Systems Manager.
Competencies
Heredia, H, CR, 14650
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Facilities, QC, Engineer, Operations, Bilingual, Quality, Engineering