Senior Engineer, Supplier Quality Assurance

New World Medical, Inc.•Rancho Cucamonga, CA

About The Position

This position administrates regulatory compliance activities related to New World Medical’s (NWM) Supplier Management. Responsible for establishing the system for managing suppliers which includes establishing systems for the approval, monitoring and validation of the suppliers. This role is the technical liaison between our suppliers and R&D/Sustaining Engineering.

Requirements

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.
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. Belt certified is a plus.
Competent in Process Audit, CAPA, PPAP, Equipment Validation and Gage R&R.
Certified Auditor Qualification or equivalent is required.
Must be able to remain in a stationary position at least 50% of the time.
Occasionally move about inside the office and travel to and from office buildings to access file cabinets, employee offices, office machinery, etc. This may include, but is not limited to, bending and walking.
Must be able to operate a computer and other office productivity machinery, such as a computer printer, computer keyboard, calculator, etc.
Ability to listen and speak with employees and suppliers. Must be able to exchange accurate information in these situations.
View and type on computer screens for long periods of time.

Nice To Haves

Strong working knowledge of DMAIC/Six Sigma problem solving process. Belt certified is a plus.
Direct experience with supplier producing product and parts in a regulatory environment (i.e. GMPs, ISO13485, 21 CFR Part 820, etc.) preferred.

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.