Supplier Quality Assurance Engineer

Job description

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. This position reports directly to the Quality Assurance and Regulatory Affairs Director.

 

ESSENTIAL JOB DUTIES AND RESPONSIBILITIES:

  • Responsible for establishing the supplier management system.
  • 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.
  • Participate 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.
  • 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 required.
  • 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 NWM requirements to all levels of manufacturing.
  • Work with suppliers on establishing robust validated measurement methodologies.
  • 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 qualification.
  • Work with suppliers to establish a structured approach for consistency and adherence to quality procedures and requirements.
  • Work closely with QA team to manage suppliers to ensure product quality.
  • 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 implementation.
  • Expected travel for this position is approximately 25%-40%.

KNOWLEDGE, SKILLS AND ABILITIES:

  • Must have good communication skills.
  • Candidate must be able to work autonomously and independently.
  • Candidate must have high energy and lots of stamina.
  • Must be a team player and have a strong work ethic.

Requirements

EDUCATION AND EXPERIENCE:

  • Bachelor's degree in engineering and minimum 5-year experience in medical device industry is required.
  • 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 a big plus.
  • Competent in Process Audit, CAPA, PPAP, Equipment Validation.
  • Certified Auditor Qualification or equivalent is required.

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 status.