New World Medical · 8 hours ago
Senior Engineer, Supplier Quality Assurance
Rancho Cucamonga, CA
Full-time
Onsite
Senior Level, Lead/Staff
$98K/yr - $111K/yr
8+ years expNew World Medical is a mission-driven company focused on enhancing vision through innovative ophthalmic surgical devices. The Senior Engineer, Supplier Quality Assurance is responsible for managing regulatory compliance activities related to supplier management, leading the qualification and maintenance process for suppliers, and serving as a technical liaison between suppliers and the R&D/Sustaining Engineering teams.
EyewearHealth CareMedical Device
Responsibilities
Lead PPAP process with suppliers to establish robust validated processes including measurement methodologies (Gage R&R)
Leads the qualification and maintenance process for suppliers, including initial and routine supplier evaluation and audits as required
Responsible for supporting Development, Engineering and Manufacturing to resolve technical issues and implement supplier corrective and preventive action (SCAR)
Works with suppliers and New World Medical’s R&D, Sustaining and Production Department to establish, maintain, and assess associated risks of their controlled manufacturing processes
Builds and maintains relationships with suppliers to establish and verify/audit control methods suitable to the nature of the parts they supply and ensure clear communication of New World requirements to all levels of manufacturing
Works with suppliers to establish a structured approach for consistency and adherence to quality procedures and requirements
Schedules, manages, and conducts audits of New World Medical existing and potential new suppliers to assess compliance to all applicable Standards, Regulations, and New World Medical Requirements
Participates in External Quality Audits as a process subject matter expert
Identifies compliance risks to current standards / regulations and assist in the planning and execution of Quality System improvements to mitigate those risks
Drives continuous improvement efforts, through facilitating, leading, and collaborating with cross functional teams including NWM and suppliers
Works closely with QA team to manage suppliers to ensure product quality
Follows up with non-conformances during in-process inspection, pre-shipment inspection, quality complaints from internal customers, product returns and safety recalls. Identify / drive root cause analysis, corrective action and preventive action implementation
Expected travel for this position is approximately 20%-30%
Qualification
Required
Bachelor's degree in an engineering or science field required
8+ years of experience with 5+ years of experience in medical device industry preferred
Direct experience with supplier producing product and parts in a regulatory environment (i.e. GMPs, ISO13485, 21 CFR Part 820, etc.) preferred
Must have knowledge of Quality Engineering discipline, including statistics
Strong working knowledge of DMAIC/Six Sigma problem solving process
Competent in Process Audit, CAPA, PPAP, Equipment Validation and Gage R&R
Certified Auditor Qualification or equivalent is required
Strong organizational, time management and project management skills with attention to detail
Must have effective communication skills
Able to work autonomously and independently
Must be a team player and have a strong work ethic
Demonstrated ability to lead, acknowledge, develop, communicate & implement strategies for developing new supplier, including qualification
Preferred
5+ years of experience in medical device industry preferred
Direct experience with supplier producing product and parts in a regulatory environment (i.e. GMPs, ISO13485, 21 CFR Part 820, etc.) preferred
Belt certified is a plus
Benefits
Medical, Dental, and Vision Insurance
401(k) with Profit Share
Bonus Opportunities
Flexible Work Schedules
Free Onsite Daily Lunches to foster team connection
Career Development Program
Tuition Assistance (after 1 year of service)
Cell Phone & Home Office Stipends
Wellness & Employee Assistance Programs
Company Events & Recognition
And more!
Company
New World Medical
New World Medical is preserve and enhance vision by delivering innovations to Benefit Humanity and supporting medical cutting edge eye care.
201-500 employees
Funding
Current Stage
Growth StageLeadership Team
Khalid Mansour
President & Chief Operating Officer
Keely Smith, CSC
Human Resources Business Partner
Recent News
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