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Director Of Quality Assurance & Corporate Regulatory Affairs

Company: Acme Monaco
Location: New Britain
Posted on: June 18, 2022

Job Description:

To develop, implement, coordinate, and ensure the organizations compliance to the scope of the quality management system. -To maintain the scope of the quality management system in alignment with the strategic direction of the organization, as instructed, for the devices and products produced, and customers and markets served. To ensure that necessary systems have been established to ensure devices and products are manufactured in compliance with customer, quality management system, regulatory and/or statutory requirements. To serve as the company ISO/quality management system representative. Essential Functions: (listed in accordance to their importance and/or frequency)The essential functions include, but are not limited to the following: -

  • Suggests and debates alternative methods and procedures in solving problems and meeting changing market opportunities.
  • To cooperates with top management personnel in formulating and establishing company policies, operating procedures, and goals.
  • Develops initial and subsequent changes of quality management system to delineate areas of responsibility, personnel requirements, and operational procedures.
  • Ensures the timely reporting of the effectiveness of the quality management system, such as weekly, monthly, quarterly, and annual reports, and as required under the scope of the quality management system.
  • Ensures the timely reporting of device quality issues to regulatory authorities, as required under the scope of the quality management system.
  • Confers with top management to formulate the fiscal budget for the quality management system.
  • To manage the Quality Assurance and Quality Control functions which report to the position, to ensure that the goals and objectives of the organization are achieved, and ensuring compliance to the scope of the quality management system.
  • Reviews technical problems and procedures of departments and recommends solutions to problems or changes in procedures.
  • To visit and/or confer with representatives of external providers (vendors) to ensure their compliance to quality management system requirements. To address and/or work with external providers to address quality and/or other issues.
  • Confers with the applicable departments concerning new devices and/or products to ensure their compliance with customer and/or regulatory requirements.
  • To confer with the applicable departments for manufactured devices and/or products to rectify any complaints, non-conformances and/or other issues.
  • To promptly discontinue further processing and/or delivery of non-conforming devices and/or products until the discrepancy or non-conforming condition has been corrected.
  • Reviews technical publications, articles, and abstracts to stay abreast of compulsory standards and regulatory requirements as they relate to the scope of the quality management system.
  • Investigate customer complaints, perform root cause analysis, identify corrective and preventive action, and prepare reports for customer submission, in a prompt manner.
  • Designs, implements, and maintains quality management system documentation for the assurance of conformity to customer, quality management system standards, and applicable statutory and regulatory requirements.
  • To enhance customer satisfaction through the effective application of the quality management system for continual improvement and/or its effectiveness. And the assurance of conformity to customer and/or applicable statutory and regulatory requirements.
  • Ensures that the processes required for the quality management system are established, implemented, and are being effectively maintained.
  • Ensures that the policies, procedures, and work instructions of the quality management system are communicated to the organization.
  • Reporting to management on the performance of the quality management system and the need for any actions and/or improvements to maintain its effectiveness.
  • Promotes awareness of customer and/or quality management system requirements throughout the organization.
  • Serves as the company's liaison to external parties on matters relating to the quality management system.
  • Performing other duties as assigned. -Required Qualifications/ Education: -
    • Bachelor's degree in from four year college or university -
    • At least ten years of related experience and/or training; or equivalent combination of education and experiencePreferred Qualifications/ Education: -
      • PhD in field relevant to medical devices covered under the scope of MDD/MDRKnowledge, Skills, and Abilities: - -
        • Proven ability to successfully manage a complex Quality Management System, e.g. ISO 9001, EN ISO 13485, 21 CFR820, MDD, MDR, MHLW, KFDA -
        • Knowledge of regulatory requirements as they relate to the devices produced and markets served
        • Ability to support third party audits by customer, registrar, and/or regulatory bodies
        • Ability to manage the quality assurance and quality control functions
        • Ability to multi-task, and set priorities to achieve the goals of the organization - -
        • Appropriate analytical skills, such as six sigma methodology, process capability, data analysis
        • Knowledge of process and product qualification and validation activities
        • Knowledge of Design and Development of devices and products -
        • Strong organizational skills and attention to detail
        • Extensive knowledge of engineering, manufacturing, and product realization activities
        • Proficient in Microsoft Office Suite or similar software
        • Proficient in verbal and written communication skills
        • Proficient in time management, planning & scheduling
        • Proficient in data interpretation & statistical analysis
        • Proficient in technical & report writing
        • Proficient in root cause and problem solving -

Keywords: Acme Monaco, New Britain , Director Of Quality Assurance & Corporate Regulatory Affairs, Executive , New Britain, Connecticut

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