Quality Assurance Engineer III (12+ months)

iso, medical device, quality engineering
Contract W2, Contract Independent, 12 Months
Depends on Experience
Work from home not available Travel not required

Job Description


Supplier Quality Assurance Engineer (SQ Engineer III) - 12 Month Contract


Johnson Service Group is seeking a SQ Engineer Reporting to the Director of Global Supplier Quality, this individual will be based out our customers US Manufacturing Facility in the Milpitas area. This role s primary function is to ensure quality standards are implemented and effective throughout the customer s Manufacturing and Service Supplier s. This SQ department member will also closely work with Global Supply Chain, Development and Manufacturing Engineering personnel at the company understand current product quality issues and assist with root cause and corrective action with suppliers.


Basic Qualifications:


  • Minimum (5) years quality/manufacturing experience
  • BS Degree in Engineering or Technical Science

Preferred Qualifications:


  • ISO 13485 or FDA regulated medical device experience
  • ISO 9001, ISO 14001, 21CFR820 experience
  • Preferred, Certified Lead Auditor

Responsibilities:


  • Data collection, analysis, and trending of supplier performance data from ERP system and PLM database.
  • Creation of metric reports and presentations for Internal, Supplier QBRs and Management Review.
  • Lead SCAR activities for supplier product and process quality issues, ensuring all facets of CAPA activities are addressed including effectiveness.
  • Work with existing and new suppliers by planning and executing audits to ensure performance to quality standards and regulatory requirements are be met.
  • Develop, communicate & implement strategies for improving performance of the customers Manufacturing & Service suppliers.
  • Partner with New Product Introduction teams to support successful component qualifications at suppliers.
  • Provide product team support for quality system design and audit, compliance assessment, and the support of steady state manufacturing processes.
  • Work closely with other QA departments within the Customer s Global Factory Network on assigning and monitoring effectiveness of Supplier Corrective Actions in a timely manner.
  • Provides supplier quality support of the customer s suppliers engaged in the production of components.
  • Lead in the development of Supplier IQ/OQ/PQ Protocols and Final Reports, ensuring sampling sizes are statistically valid.
  • Work with suppliers to establish and maintain controlled manufacturing processes utilizing Control Plans and PFMEA s.

Additional Responsibilities:


  • Act as a change agent who accepts and supports new ideas and processes.
  • Commitment to cost reduction/controls.
  • Lead the on-going maintenance and continual improvement of Supplier Quality processes.
  • Update/creation of internal procedures as required.
  • Participate in corporate quality improvement projects as required.

Required Knowledge and Skills:


  • Proven working knowledge of auditing methodologies associated with ISO 9001 or ISO 13485 standards.
  • Quality concepts/tools (Pareto, fishbone diagram, FMEA, etc.).
  • Proficient understanding of engineering and manufacturing terminology and processes.
  • Excellent comprehension of engineering drawings and specifications.
  • Proactive, self-motivated, and empathetic work ethic in a fast-paced work environment.
  • Ability to effectively interface and communicate with multiple constituents, including senior management, suppliers, consultants, and employees of all levels

Posted By

Kevin Fedor

Dice Id : 10112459
Position Id : 5981611
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