Quality Engineer- DH- North Bay Area-Medical Device or Aerospace exp. Preferred

• Develop and maintain QMS systems, maintain surveillance of applicable quality standards and manage integration into our QMS as necessary
• Performs internal audits, supplier audits and host external audits as necessary
• In collaboration with Design & Manufacturing Engineering develop Inspection Test Plan and review
• Work with QA manager to develop KPI’s for appropriate systems measuring organizational performance, report on findings and work closely with appropriate managers and staff to address deficiencies and improvement plan
• Participate in data collection for Monthly Quality Metrics to foster process improvement in coordination with Manufacturing Engineering and under the guidance of the QA Manager
• Participate in process control, risk management and process improvement, qualification/process validation data (Statistical Process Control) captures data with conclusions drawn; projects defined in collaboration with QA Manager to drive improvements
• Participate in data collection and analysis leading to corrective action and root cause closure of defects/scrap identified under the guidance of the QA Manager
• Participate in cross-functional teams to perform product and component failure analysis and resolution
• Participate in the development of new practices for measurement system analysis activities (GR&R’s FMEA) and procedures to promote data collection and in-process inspection in the manufacturing work centers under the guidance of the QA Manager
• Provide technical support to QA Inspectors and/or other departmental personnel as required
• Promote an awareness of quality goals and processes throughout the operations and creates an environment committed to continuous quality improvement
• Participates in special projects and/or testing with Design Engineering
• Other duties as assigned
• High School or G.E.D. equivalent; Engineering degree preferred; ASQ CQE certification a plus
• Five (5) years’ experience in an ISO 9001, ISO 13485 or AS9100 manufacturing environment
• Training or experience in Quality Assurance management and industry standards for ISO 9001:2008, ISO 13485 or AS9100; RoHS and REACH experience a plus
• Experience with SPC (qualification/process validations), FMEA (Risk Management ISO 14971), ISO 9001, ISO13485/Medical GMP’s, CAR/RCA, NCM/MRB, Auditing, Supplier Quality Management; Process Auditing Experience; RoHS and REACH a plus
• Must be a strong advocate for the customer and for product quality
• Hands-on experience with use of quality tools such as sampling plans, control charts, SPC and quality improvement techniques such as Cause/Effect diagrams, Pareto charts, Histograms and SPC software with “MiniTab” preferred

• Hands-on experience with measuring tools, including but not limited to calipers, micrometers, drop gauges and proven experience with common measurement techniques and applications, testing and inspection equipment
• Ability to read detailed engineering drawings and schematics
• Good ability to troubleshoot and solve problems
• Strong mathematical skills including Metric and English, measurement manipulation and computation with fractions
• Strong attention to detail, time management, organizational and communication skills
• Working knowledge of Microsoft Office Products


Please send resume to kjohnson@nelsoninteractive.net

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