Edwards is looking to solve the problem of ensuring compliance with regulatory requirements and optimizing product development, internal and external device manufacturing, and device distribution to impact patients around the world with pioneering technology.
Requirements
- Demonstrated Project Management Experience.
- Highly regulated industry experience
- Experience with supplier/vendor management and qualification activities with new suppliers, CMOs (Contract Manufacturing Organizations), or OEMs for new products.
- Experience with CAPAs, SCARs, NCRs, Change Notifications, and/or Auditing.
- Demonstrated experience driving component testing, test method validations, and testing/validating equipment.
- Well-versed in statistical tools such as Gage R&R, Statistical Process Control, Process Capability Studies, Hypothesis Testing, and other statistical techniques related to manufacturing.
- Knowledge of the manufacturing process for injection molding, machining, and extrusions.
Responsibilities
- Lead in the investigation of complex manufacturing product quality and compliance issues (e.g., SCARs (Supplier Corrective Action Reports), CAPAs, non-conformances, audit observations) for all production processes based on engineering principles; analyze results, make recommendations, and develop reports
- Lead supplier notification of change (NOC) projects, including having routine meetings with suppliers, lead cross functional teams to evaluate proposed changes and create a path for approval, execute the predefined tasks for approving the NOC, properly document the objective evidence for the NOC and acquire relevant approvals.
- Ensure validation methods of critical suppliers and incoming quality control are aligned with international standards, global regulations, and industry best practices.
- Lead the development and execution of complex experiments and test methods (including reviewing protocols and reports) to validate and improve products (including evaluation of source materials and suppliers) and manufacturing processes/methods based on engineering principles; analyze results, make recommendations, and develop reports and collaborate with team members to drive project completion.
- Perform supplier audits, act as Lead Auditor, and work with the supplier to perform proper root cause analysis to address audit findings using tools such as 5 Whys, DMAIC, PDCA, etc.
- Support necessary Product Risk Assessments for relevant complaints that affect supplier processes.
- Develop training and documentation materials for production (e.g., work instructions) to enable knowledge transfer of project and manufacturing processes.
Other
- Bachelor's degree in engineering or scientific field with 6 years of experience in Supplier Quality, Quality Engineering, or Manufacturing Engineering functions; OR a Master's degree in engineering or scientific field with 5 years of experience in Supplier Quality, Quality Engineering, or Manufacturing Engineering functions
- Must have the ability to travel domestically and internationally (mostly domestic) between 10% - 25%
- Demonstrated leadership capabilities in coaching/guiding less seasoned engineers and teammates.
- COVID-19 vaccination is required as a condition of employment, unless a medical or religious accommodation for exemption is granted.
- Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.
