
Quality Representative
2 weeks ago
Innovation starts from the heart. Edwards Lifesciences is the leading global structural heart innovation company, driven by a passion to improve patient lives. With millions of patients served in over 100 countries, each team makes a meaningful contribution by improving patient outcomes and discovering lasting solutions for unmet patient needs. Our Representative position is a unique career opportunity that could be your next step towards an exciting future.
How you'll make an impact:
- Identify opportunities for simplification to continuously improve workflow
- Collaborate internally and externally with 3PL employees to investigate non-conformities/abnormalities & perform detailed root cause analysis by utilizing appropriate system application (e.g., JDE, TeamCenter)
- Perform routine inspections and may be a second approver on material disposition as required
- Mitigate quality risk before non-conformance happens through strong partnership with 3PL personnel
- Conduct regular audits to prevent 3PL process deviations
- Monitor the data based on the complaints & trending to propose appropriate actions
- Improve and/or clarify procedures as required to reflect current practices & provide coaching/training
- Other incidental duties
What you'll need (Required):
- Holds H.S. Diploma or equivalent with 4 years' relevant experience in quality related functions and DHR auditing; or Bachelor's Degree with 2 years' relevant experience
- Proven track record in process and product auditing, with successful contributions to process improvement initiatives
- Skilled in conducting inspections and ensuring compliance with quality standards
- Strong communication and interpersonal skills, with experience collaborating effectively with suppliers and cross-functional stakeholders
What else we look for (Preferred):
- Experience working in Distribution Centers (DCs) and pharmaceutical or similar regulated industries
- Substantial understanding of drawings and specifications in inspection
- Substantial understanding of quality system how it interacts other functions and areas within the organization
- Good computer skills including MS Office Suite, JDE
- Ability to interact professionally and proactively escalate issues
- Substantial problem-solving, and critical thinking skills
- Substantial knowledge of operations
- Attention to detail
- Must be able to work in a team environment under minimum supervision.
- Adhere to all company rules and requirements (e.g., pandemic protocols, Environmental Health & Safety rules) and take adequate control measures in preventing injuries to themselves and others as well as to the protection of environment and prevention of pollution under their span of influence/control
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