Senior Engineer, Supplier Quality
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Job Location:
Monthly Salary:
Posted on:
4 hours ago
Vacancies:
1 Vacancy
Job Summary
Imagine how your ideas and expertise can change a patients life. Our Quality teams help shape the development of groundbreaking technologies to ensure each stage of our innovation process is held to the highest standards of integrity and safety. Youll bring your passion for problem solving and partner with various teams to influence decision-making for a products entire lifecycle. Your work will involve you optimizing product development to impact patients around the world with pioneering technology.
How you will make an impact:
Investigate and develop action plans for complex manufacturing product quality and compliance issues (e.g. SCAR management non-conformances productivity and audit observations) for all supplier processes based on engineering principles and Edwards quality standards.
Own and coordinate supplier Notice of Change (NOC) requests. Manage supplier project plans facilitate part qualification process and ensure closure of any change plan deliverables.
Monitor supplier performance and develop improvement plans to mitigate risk and supply chain disruptions. Activities include supporting Supplier Business Reviews Scorecard management Critical Control Point monitoring and overall quality performance assessment.
Identify and ensure the optimization of complex Manufacturing and/or R&D processes using engineering methods (e.g. SIX Sigma and LEAN methods) for design for manufacturing and for continuous process opportunities for re-design/design of basic equipment tools fixtures etc. to improve manufacturing processes and reduce risk.
Update and maintain supplier file content including Supplier Management system administration support Approved Supplier List (ASL) activities and any required Preference Category status changes.
Partner with Supplier Management to onboard new suppliers in alignment with each category strategy. Activities include developing and finalizing Quality Agreements supporting Technical Assessment Supplier Management system administration (SQMS) and conducting the initial qualification audits.
Support the Quality Audit program for all identified suppliers (Surveillance Qualification Performance). Supplier Quality Engineers will conduct the Quality Audit drive corrective actions and ensure closure of any findings.
Support Edwards sites in their Receive on Certification program owning supplier agreements SPC data reviews and process audits where appropriate.
Train coach and guide lower level employees on routine procedures.
Other incidental duties assigned by Leadership.
What youll need (Required):
Bachelors Degree in Engineering or Scientific field 4 years experience Required or
Masters Degree or equivalent in Engineering or Scientific field 3 years experience Required or
Ph.D. or equivalent in Engineering or Scientific field 0 years experience Required
What else we look for (Preferred):
Proven expertise in usage of MS Office Suite; CAD experience preferred
Strong documentation communication and interpersonal relationship skills including negotiating and relationship management skills
Working knowledge and understanding of statistical techniques
Previous experience working with lab/industrial equipment required
Substantial understanding and knowledge of principles theories and concepts relevant to Engineering
Strong problem-solving organizational analytical and critical thinking skills
Substantial understanding of processes and equipment used in assigned work
Good leadership skills and ability to influence change
Knowledge of and adherence to Quality systems
Strict attention to detail
Ability to interact professionally with all organizational levels
Ability to manage competing priorities in a fast paced environment
Must be able to work in a team environment including inter-departmental teams and key contact representing the organization on contracts or projects
Ability to interact with senior internal and external personnel on significant matters often requiring coordination between organizations
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
Required Experience:
Senior IC
Key Skills
- Quality Assurance
- Six Sigma
- Design Controls
- FDA Regulations
- ISO 9001
- Minitab
- Root cause Analysis
- ISO 13485
- Quality Systems
- Quality Management
- As9100
- Manufacturing
About Company
Edwards Lifesciences (NYSE: EW), is the global leader of patient-focused medical innovations for structural heart disease and critical care monitoring. We are driven by a passion for patients, dedicated to improving and enhancing lives through partnerships with clinicians and stakehol ... View more
