Job Requirements

Primary Responsibilities:

• Deputy Management Representative Understand and perform tasks described within the Quality System for Management Representative duties.
  
• Develop, administer and maintain quality assurance procedures and activities required to ensure that the companys processes and products are in compliance with applicable quality standards and requirements.
  
• Upgrades and implements Quality Management Systems, drafting procedures or revising existing SOPs, and training teams for proper adoption of new system requirements.
  
• Managing the Internal/ External Audit process with internal customers and third party certification and regulatory bodies (FDA, FDB, Notified Body, etc.).
  
• Maintaining and organizing the companys internal FDA quality audit program and managing corrective and preventive action plans.
  
• Employ quality assurance methodologies in support of engineering, manufacturing and regulatory functions.
  
• Coordinates the Design Control projects in cooperation with the customers, including writing of internal product specification documents and directing phased Design Control activities if required by the customer.
  
• Active participant in all stages of design development, V&V testing and design control activities, ensuring quality assurance considerations and requirements met.
  
• Should exhibit the ability to evaluate requirements for testability, design efficient test cases, and write extensive technical documentation.
  
• Participate in the review of product requirements, design requirements, software requirements specifications, and functional specifications.
  
• Responsible for developing and maintaining sterilization validation and material biocompatibility activities, as applicable.
  
• Initiates and leads comprehensive Risk Management projects for compliance to ISO 14971, including: developing FMEAs, performing hazard analyses, and revising documentation as needed to support total product lifecycle considerations.
  
• Develop and implement quality control and inspection procedures for receipt and control of incoming materials, in-process materials and final product acceptance activities.
  
• Define quality control standards and test; specify test equipment and procedures.
  
• Helps establish and maintain test instrument calibration procedures and maintenance schedules.
  
• Identify quality assurance metrics; analyze and report trends to management.
  
• Review and host meeting(s) for nonconforming materials.
  
• Liaise with suppliers over quality issues.
  
• Assist in the failure investigation of product complaint and CAPA activities.
  
• Review for completeness and adequacy of the Design History record for the manufacturing builds.
  
• Initiates and coordinates all corrective action responses to the FDA for any variation notices
  

Knowledge, Skills, and Experience (check all that apply):

Education Level: Bachelors degree

Experience: 5+ years of experience in the medical device industry

Other Qualifications:

• Lead Auditor certification for ISO 13485 a plus.
  
• Thorough knowledge of FDA Quality System requirements, ISO 13485:2003 (Quality System) requirements, ISO 14971 (Risk Management) requirements, Medical Device Directives (MDD) requirements, Knowledge of Good Manufacturing Practices (GMP) and applicable Quality System Standards.
  
• Familiar with EN 60601, Safety requirements for medical electrical systems.
  
• Familiar with ISO 62304, Medical Device Software Software Life Cycle processes.
  
• Ability to analyze and interpret standards, technical procedures, professional journals and governmental guidance and regulation documents.
  
• Understanding of sterilization validation and material biocompatibility requirements.
  
• Understanding of software, electrical and mechanical engineering principles.
  
• Excellent verbal and written communication skills.
  
• Effective problem solving skills.
  
• Ability to work in a team minded approach to achieve individual and company success.
  
• Fluent in computer skills and, at a minimum, the use of Microsoft Office Word, Excel, PowerPoint and Project programs.
  
• Demonstrated project management skills and experience.