Supplier Quality Assurance Engineer
Company: New World Medical
Location: Rancho Cucamonga
Posted on: August 2, 2022
This position administrates regulatory compliance activities
related to New World Medical's (NWM) Supplier Management. This
position's key functions relate to the management of NWM Suppliers.
Responsible for establishing the system for managing suppliers.
ESSENTIAL JOB DUTIES AND RESPONSIBILITIES:
- Responsible for Establishing the Supplier Management
- 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
- Participate in External Quality Audits as a process subject
- Identifies compliance risks to current standards / regulations
and assist in the planning and execution of Quality System
improvements to mitigate those risks.
- Responsible for supporting Development, Engineering and
Manufacturing to resolve technical issues and implement corrective
and preventive action.
- Drive continuous improvement efforts, through facilitating,
leading, and collaborating with cross functional teams including
NWM and suppliers.
- Leads the qualification and maintenance process for suppliers,
including initial and routine supplier evaluation and audits as
- Works with suppliers and New World Medical's Sustaining and
Production Department to establish, maintain, and assess associated
risks of their controlled manufacturing processes.
- Build and maintain 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.
- Work with suppliers on establishing robust validated
- Responsible for reporting of quality trends and information to
management on the performance of suppliers.
- Demonstrated ability to lead, acknowledge, develop, communicate
& implement strategies for developing new supplier, including
- Work with suppliers to establish a structured approach for
consistency and adherence to quality procedures and
- Work Closely with QA team to manage suppliers to ensure product
- Follow 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
- Expected travel for this position is approximately 25%-40%.
KNOWLEDGE, SKILLS AND ABILITIES:
- Must have effective communication skills.
- Able to work autonomously and independently.
- Must be a team player and have a strong work ethic.
EDUCATION AND EXPERIENCE:
- Bachelor's degree in an engineering or science field
- 5+ years of experience in medical device industry
- Direct experience with supplier producing product and parts in
a regulatory environment (i.e. GMPs, ISO13485, 21 CFR Part 820,
- Must have knowledge of Quality Engineering discipline,
- Strong working knowledge of DMAIC/Six Sigma problem solving
process. Belt certified is a plus.
- Competent in Process Audit, CAPA, PPAP, Equipment
- Certified Auditor Qualification or equivalent is required.
- Must be able to remain in a stationary position at least 50% of
- 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.
This description reflects management's assignment of essential
functions, it does not proscribe or restrict the tasks that may be
New World Medical, Inc. (NWM) is an Equal Opportunity Employer. NWM
takes pride in maintaining a diverse environment and our policies
are not to discriminate in recruitment, hiring, training, promotion
or other employment practices for reasons of race, color, religion,
gender, national origin, age, sexual orientation, marital or
veteran status, disability, or any other legally protected
Keywords: New World Medical, Rancho Cucamonga , Supplier Quality Assurance Engineer, Engineering , Rancho Cucamonga, California
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