The Senior Quality Engineer ensures administration of the QMS principals and functions to support product, customer requirements and the quality plan. Position includes development, operation of quality control systems, application and analysis of testing/inspection procedures. Use metrology and statistical methods to diagnose and correct improper quality control practices. RESPONSIBILITIES:â¢Supervise Quality Assurance personnel.â¢Lead Quality Planning Process for new and existing products including, Process Flow Charts, DFMEA, DFM, Quality Plans, Working Instructions, contract review support (quality provisions)â¢Participate in Design Review Process for Quality Planning related requirementsâ¢Support ISO9001, ISO13485, AS 9100 and ISO14001; Third Party Compliance Auditsâ¢Serve as the back-up for the Director of Quality as Management Representative as requiredâ¢Key member of the Management Review Processâ¢Perform the duties of an Internal Auditor as defined by the quality plan.â¢Provide guidance to other facilities in regards to ISO/AS QMS standards.â¢Responsible for managing customer complaints and provide corrective actions to customers regarding quality related issuesâ¢Investigate the cause of product nonconformities; initiate and drive the appropriate corrective actionâ¢Lead & facilitate process improvement initiatives to address product and systemic nonconformitiesâ¢Support the Sourcing department with supplier quality engineering activities (SCAR’s, Quality requirement flow down, quality plans, etc.).â¢Track and maintain data analysis of key metrics and performance data. â¢Oversee the MRB function and personnel.â¢Visit customers and suppliers internationally and domestically to ensure compliance with quality and customer requirements.â¢Perform other related and associated duties as required or directed.EDUCATION/EXPERIENCE REQUIRED:â¢Bachelor’s Degree in Engineering or related job discipline experienceâ¢5+ years experience in manufacturing/quality environmentâ¢Proficiency in quality toolsâ¢Project management skillsâ¢Experience in new product development initiatives and design reviews (good understanding of manufacturing processes, molding, plating, tooling and/or screw machining is desirable)â¢Experience in Quality Planning Process (PPAP) and control plansâ¢Experienced in Quality Control metrologyâ¢In depth knowledge and experience in ISO9001 or ISO13485 or AS9100 Compliance Standardsâ¢Experience in Continuous Improvement philosophy and methodology (Root cause and problem solving)â¢Strong computer skills (access, excel, pivot tables, PowerPoint, word)â¢Effective communication skills (written and verbal)â¢Ability to travel domestically and internationally. EDUCATION/EXPERIENCE PREFERRED:â¢Bachelor’s Degree in Mechanical or Electrical Engineering preferredâ¢CQE preferredâ¢Medical “implantable” knowledge and experience a plusâ¢Green Belt/ Black Belt a plusâ¢Experienced in Quality Control metrology utilizing data acquisition techniques is a plusâ¢Electrical testing experience preferred (Dielectric, resistance, insulation resistance, etc)PHYSICAL DEMAND:â¢Computer and phone usageMENTAL ATTENTION OR VISUAL DEMAND:â¢Frequent mental and visual attentionCRITICAL DIMENSIONS:Characteristics: Commitment to personal and professional improvement; Commitment to expanding educational experience; Effective listenerCapabilities: Ability to interact effectively with all other team members; an openness and ability to change. Innovative solutions, technical/functional proficiency, Framing work through the eyes of the customerCapacity: Team oriented individual; Positive attitude, Functions comfortably in the absence of complete informationWORKING CONDITIONS:â¢Office environmentâ¢Involvement in manufacturing environmentâ¢Travel (
Quality Engineer Job in Hudson 01749, Massachusetts US