Job Description

Summary of Position:

• Manage and coordinate compliance of the New Product Development Quality Engineering function.
  
• Responsible for ensuring products are developed in compliance with Quality System, FDA, ISO 13485-2003, and company requirements.
  
• Provide support in the rapid resolution of production issues, product complaints and/ or safety issues.
  
• Manage the technical functions assigned to provide operational and functional support for compliance and continuous improvement activities.
  

Essential Job Functions:

• Define, lead and implement the quality engineering function in design and development of products, and in transfer and steady state phases of manufacturing operations.
  
• Provide mentoring and leadership to Quality Engineering, Quality Assurance and/or Compliance areas.
  
• Manage the Quality technical group (Engineers and Technicians) whose function is the establishment of the Quality System, design validation, process validation, control and resolution of nonconforming issues and leading continuous improvement efforts.
  
• Manage quality engineer support and provide guidance to upper management during product/technology evaluations and acquisitions.
  
• Design, develop and implement quality system processes for compliance with company, government regulations and international standards requirements.
  
• Provide timely information to department and management on issues which will affect the company??s performance.
  
• Provide risk assessment reports to management to ensure all new products met compliance to quality systems.
  
• Coordinate resource allocation to ensure appropriate quality engineering support for new product development teams. Develop and monitor departmental budgets.
  
• Establish key performance indicators for the Quality engineering and ensure support of operational objectives.
  
• Participates in the Material Review Board meetings and takes the lead with other functional groups to determine root cause failure and implement actions to prevent recurrence.
  
• Provide Quality Assurance support during FDA, corporate and notified body inspections/assessments during Quality Systems reviews.
  
• Develop, maintain, and implement company??s Quality policies and procedures.
  
• Assess priorities and makes project assignments for employees to ensure business priorities are met.
  
• Perform job reviews, recommend salaries and promotions, hire employees, and initiate disciplinary actions.
  
• Participate in training and provides input to training of other employees on company procedures and policies, technical and managerial skills.
  
• Perform the roles and responsibilities of a Quality Engineer including:
  
• Provide quality engineering representation on cross functional product development team.
  
• Lead the development of risk assessments, physical and functional test methods, design verifications and validation protocols and reports.
  
• Lead the development of Process FMEAs, process validation requirements and equipment qualifications.
  
• May conduct and/or coordinate testing outlined in protocols and test methods.
  
• Reviews inspection criteria, inspection methods and procedures to assure acceptable quality standards that meet the needs of the business.
• Provides support and assures QSR compliance in product and process validations and product and process transfers.
  
• Participate in project planning, budgeting, scheduling and tracking.
  
• Reviews all documentation related to product quality such as test procedures, raw material, specifications, operational procedures and approves as appropriate to ensure product quality.
  
• Initiate new revised documentation and tracks through approval cycles and implementation.
  
• Participate in supplier audits. Provides technical and quality support to suppliers, the Manufacturing Engineering group and to the Customer Service department on the analysis of product returned from the field.
  
• Monitors quality trends and conducts technical and statistical investigations on quality problems, reporting the results and recommendation in a timely manner.
  
• Prepares for and participates in internal and external audits and implements corrective action to audit observations to prevent recurrence.
  
• Supports operational teams responsible for investigating and providing corrective action for NCRs and/or CAPAs.