Quality Engineer MPQE

Our Client is searching to fill the role for Medical Products Quality Engineer (MPQE).To perform this job successfully, the individual we seek will have a medical device or medical product manufacturing background, great communication skills, a collaborative work style, and a desire to drive a growing market This position is responsible for leading the Medical Products Quality aspect of our Quality Management This includes Quality Engineering and all traditional quality verification activities, such as but not limited to final inspection, receiving and in-process inspection, precise digital inspection activities, independent lab testing, customer and internal auditing activities, continuous improvement processes, supplier quality, scheduling of the inspection workload, and overall Quality Management System compliance to several certification agencies including ISO9001, ISO14971, MDR, ISO13485, MDSAP and others in the USA, UK, Europe, and Canada as

This will be a transformational role driving the company beyond compliance to best-in-class quality performance and is a strategic part of the growth ambitions of the The QMS and MPQE should ensure continuous production of quality products consistent with company established standards by performing the duties The MPQE is the focal point for internal and external customer communication and process plan He / she will ensure a cohesive approach to meeting internal goals and objectives as well as our customer s requirements

Essential Responsibilities:

• Ensure that Quality Management Systems (QMS) comply with the requirements of internationally recognized quality management systems including ISO 9001, ISO 14971, ISO 13485 and MDSAP
  
• Ensure that processes necessary for the company s Quality Management System (QMS) are established, implemented, and maintained
  
• Ensure the promotion, awareness, and compliance to customer requirements throughout the organization
  
• Develop and streamline inspection processes throughout the shop
  
• Manage and improve Cost of Quality to the company related to the medical business segment
  
• Act as the company s primary customer quality assurance point of contact
  
• Ensure timely execution and conformance of all quality and design requirements
  
• Provide final disposition on quality issues
  
• Develop internal auditing processes to ensure ongoing compliance of customer standards
  
• Establish and maintain effective quality procedures, documentation systems, tools, metrics, and process improvements required to meet quality system standards
  
• Provide technical and statistical expertise to the team
  
• Provide training to assure awareness and understanding of company and customer requirements
  
• Monitor and support coverage of internal and external audit requirements
  
• Create, document, and implement inspection criteria and procedures
  
• Manage all Quality Engineering functions, , raw material certification review, KPC activity, root cause analysis,
  
• Recommend and implement improvements to quality department including improved technology, systems improvements, procedural updates,
  
• Manage the collection, analysis, interpretation, and reporting of inspection metrics related to medical products
  
• Manage non-conforming product processes and scrap metrics
  
• Oversee and manage the ISO13485, ISO14971, ISO9001, and other applicable quality systems
  
• Communicate quality management budget requirements including certifications, training,
  

Requirements

• BS Degree in Engineering/Engineering Technology preferred
  
• Minimum of 5 years Quality Management Experience within the medical product and/or medical device market
  
• Experience with applying quality processes and procedures in a manufacturing/precision machining environment
  
• Experience with application of ISO quality standards and their audits
  
• Strong information technology skills especially related to automated inspection, SPC implementation and ERP systems
  
• Ability to create and effectively communicate regulations/standards
  
• Ability to manage and execute on multiple critical projects simultaneously
  
• Strong ethics to escalate issues in the face of competing company priorities
  
• Experience utilizing Lean Manufacturing and Kaizen techniques
  
• CMM and visual inspection system experience a plus
  
• Knowledge of international quality standards a plus
  
• Must exhibit exemplary diplomacy with customers
  

Benefits