Quality Engineer

Qual-Pro Corporation provides electronic manufacturing solutions to multiple industries including aerospace, defense, ISR, medical, and precision industrial controls. Our company offers a challenging and rewarding environment with a tremendous opportunity for career growth. This position reports to the Engineering Manager.

Summary of Job Duties:
The Quality Engineer has multiple responsibilities to ensure that the manufacturing process produces product that meets or exceeds customer expectations. To assist with the implementation of a comprehensive quality management system, and to support quality objectives of the company the ideal candidate is a fast learner who can handle multiple projects and work well as part of a team. Develop processes; control plans, PPAP plans, validation and
verifications plans, first article processes, and metrics to support world-class quality standards are required. As a Lean practitioner, the successful candidate will have experience participating in or leading Kaizen/Continuous Improvement events that resulted in measurable improvement in Quality performance.

Responsibilities:
• Establish and define Standards and Procedure of development requirements for the product
• Formulate, implement and review work procedures to ensure effectiveness and efficiency to meet quality requirements
• Review the verification & validation of medical device development and product evaluation according to ISO and FDA requirements and actively provide constructive feedback to development team
• Participate in risk and hazard assessment during the new product Implementation phase of production
• Establish and maintain high quality test procedures and methods to be used in present and future software and hardware testing and development that comply with the company quality standards and deliverables
• Work with Contract Manufacturer customers to specify & qualify the reliability and testing requirements for components and/or assembled parts of the incoming inspections
• Oversee quality tests and qualify the release of products at the manufacturing side
• Coordinate on the quality trends, including the corrective and preventive actions
• Oversee the resolution of quality-related problems in the development and manufacturing environment resulting from supply or production imperfections
• Assisting Regulatory Manager with monthly reports and data collection activities
• Ensure the proper maintenance of document control processes and devices
• Confer with Engineering Manager on production and personnel issues. Also assist with preparation of various quality reports
• Participate on/with continuous improvement teams
• Randomly examine production documents (router/Traveler) to ensure that all assembly, inspecting, and testing steps were performed according to Qual-Pro’s practices
• Provide Supplier Quality Engineering support to the Procurement function by auditing Supplier facilities and monitoring supplier performance data
• Follow-up on supplier corrective actions submitted
• Monitor and analyze product non-compliance on assemblies to reduce defects
• Monitor ESD compliance through production
• Analyze customer returns to determine cause and prevention
• Perform follow-up on corrective actions to determine effective implementation
• Perform periodic audits of production processes against procedures
• Monitor and support receiving inspection activities
• Other duties may be assigned

Required education, experience and attributes of a successful candidate:
• “Must have relevant, recent and verifiable EMS experience”
• Minimum of a BSEE required
• Experience working in ISO 9001 or AS9100-certified electronics manufacturing environment required
• Auditing experience against the ISO 9001 and AS9100 requirements
• Knowledge of DFAR regulations
• ISO13485 experience is a plus
• 2-5 years related experience and training in Six Sigma or equivalent statistical analysis techniques, lean principles and team/project management. Green Belt or Black Belt certification is a plus
• Must have strong computer skills with proficiency in Microsoft Office
• Knowledge of Process Analysis: process measurements, process flow diagrams, I.O.
diagrams, cause & effect diagrams, and Pareto Diagrams and Histograms
• Experience interpreting blueprints, Bill-Of-Materials, data sheets and test reports
• Excellent communication skills and ability to communicate with all levels of management
• Experience using Six Sigma/Lean/Quality tools to improve processes
• Experience working in an EMS environment preferred
• In order to comply with ITAR requirements, U.S. persons are required for this position

Negotiable Requirements:
• Diploma/Degree in Engineering (preferably Quality Engineering/Management)
• Experience in quality assurance and control will be advantageous
• Experience working in a production environment with practical process control experience
• Possess strong statistical and analytical skills, ISO requirements
• Possess good interpersonal, communication and auditing skills
• Proactive, independent and self-motivated
• Functional/ Technical Certifications that would be an added advantage:
• Certified Internal Auditor ISO13485, ISO 9001-2008, AS9100
• Knowledge of medical device regulatory requirements, eg. Europe CE Marking or US
• FDA Certification experience
• AS9100 certification experience
• Six Sigma Black Belt is a Plus

Our Corporate Mission and Philosophy: “We build partnerships right, the first time.”

Qual-Pro Corporation is an equal opportunity employer and works in compliance with both federal and state laws. We are committed, and encourage others to, abide by the rules of Equal Employment Opportunity. Qualified candidates will be considered for employment regardless of race, color, religion, age, sex, national origin, marital status, medical condition or disability. For immediate consideration, please submit a resume and salary history to careers@qualpro.com. Qual-Pro Corporation uses E-Verify in our application package.