Medical Quality Systems Engineer
hace 5 días
We are seeking a highly skilled Medical Quality Systems Engineer to join our team at Edwards Lifesciences.
About UsEdwards Lifesciences is the global leader in patient-focused medical innovations for structural heart disease, as well as critical care and surgical monitoring. We are driven by a passion to help patients and collaborate with the world's leading clinicians and researchers to address unmet healthcare needs.
Job SummaryThis role will be responsible for ensuring compliance of the QMS and compliance within quality processes (e.g., CAPA, NCR, ECR, internal and external auditing, training). The ideal candidate will have excellent problem-solving and critical thinking skills, strong communication skills, and the ability to interact professionally with all organizational levels across sites.
Key Responsibilities- Provide complex assessments including audits to ensure conformance with applicable regulations and EW policies and procedures.
- Assess objective evidence to determine conformity to requirements listed above, including ranking the levels of nonconformance findings.
- Plan annual audit schedule, determine and assign SMEs to audits, establish audit content, allocate time, and schedule meetings.
- Execute audit considering scope to assure efficient and effective use of scheduled time allocations.
- Identify, lead and implement business process improvement solutions for Quality Systems, including developing changes to procedures, to improve operation, efficiencies, and user experience, while supporting the integrity of the business process.
- Provide teams first-level support to Quality, Documentation and PCS Systems users, e.g., CAPA, NCR, Change, Training, Maintenance, for system usage and process requirements.
The ideal candidate will have:
- Bachelor's Degree in Engineering or Scientific field, 6 years of experience minimum, including either industry or education Required.
- Proven expertise in MS Office Suite and experience with quality systems (e.g., CAPA, Ignite).
- Experienced in GxP.
- Good project management skills and related software tools preferred.
- Excellent written and verbal communication skills including influencing and relationship management skills.
- Ability to read, comprehend, write and speak English fluently, required.
- Full knowledge and understanding of Edwards policies, procedures, and guidelines relevant to quality systems.
- Strict attention to detail.
We offer an estimated salary range of $120,000 - $180,000 per year, depending on experience and qualifications.
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