Global Quality Assurance / Regulatory Compliance Specialist

Radiometer New Port Richey , FL 34652

Posted 7 months ago

This position will manage the PALL Aeropower Global Quality Management Systems and Contract Review department. Primary responsibilities are:

  • Maintaining all required quality systems and certifications, and driving a QMS that supports business improvement.

  • Ensuring Customer quality requirements/terms and conditions are aligned with the Company's policies and manufacturing and process capabilities, while driving quality related cross-functional improvements throughout the business.

  • Identify and coordinate cross-functional / multi-site activities to ensure regulatory and Pall Corporate compliance of Corporate and Business Unit Quality Management System requirements.

  • Meet objectives, goals and timeline requirements communicated by BU customer, regulatory certification and Corporate

  • Assure internal and external customer satisfaction through effective audit management and timely response to corrective actions

  • Support the Corporate QARA Quality Management System Lead in the deployment of the QARA strategy, objectives and targets.

  • QA / RA Systems 30%

  • Drive development of a system that supports the business and is the backbone for DBS

  • Maintain all customer required quality certifications, including AS-9100

  • Implementation of harmonized Aeropower Business Unit Quality Management System in alignment to the Corporate Quality Management System.

  • Drive cross Business Unit QMS harmonization to reduce muda and cost, develop robust procedures for best practice sharing and implementation.

  • Support the development of integrated Management Systems.

Audit process:

  • Developing Business Unit risk based internal audit program.

  • Develop a breadth, depth and pool of competent auditors.

  • Management of audits via SmartSolve.

  • Ensure audits are executed within agreed timescales.

  • 3rd party, customer and Corporate audits are supported.

  • Responses to internal / customer, 3rd party and customer audit findings are addressed efficiently.

  • Audit trends are analysed and appropriate action taken.


  • Contract Review and Order Management 30%

  • Establish KPI's for the QCR function and drive team to meet quantitative goals

  • Own the process and performance of the Quality Contract Review function and drive improvement using the DBS

  • Research, read/interpret Customer purchase order requirements and determine internal compliance with all applicable standards/specifications

  • Liaise with internal/external stakeholders to address compliance/order gaps; driving all tasks to resolution.


  • Customer Interface 10%

  • Works with Customers, Pall Sales and Engineering to address quality conflicts between our system and customer requests

  • Participate in customer meetings to address customer concerns and requirements on site or at customer's site


  • Staff Management 30%

  • Lead the Quality Systems and Quality Contract Review teams

  • Select members, develop their skills and career path, and set direction for the team

  • Coordinate resources to present "one quality face" within Pall and to Customers

  • Provide coaching and leadership to the Quality Contract Review department and cross functional teams as required

  • Manage daily contract review completion goals

SmartSolve Management:

  • Support the deployment of SmartSolve modules.

  • Produce analysis /reports from reports held within SmartSolve

Management Review:

  • Ensure the Business Unit Management Review is completed in line with the applicable ISO and Corporate requirements

  • Ensure actions from Management Reviews are completed

  • Ensure common themes, trends, risks and opportunities from the site and Business Unit management reviews are addressed systemically

Training and Development:

  • Those in QARA roles are competent to execute their activities.

  • Oversee the training of all Associates with the Business Unit to ensure the role and importance of QARA within the organization is understood.

  • Drive QARA culture with the organization.

  • Coordinate responses to customer questionnaires, certification requests and surveys where required.

  • Perform other related duties as assigned

  • Bachelor's Degree in Business Administration, Engineering or related area preferred. In lieu of the degree, 10 years of relevant work experience.

  • Quality Assurance experience and knowledge of ISO 9001/AS9100 standards and Quality systems, required

  • General understanding of aerospace quality systems including, but not limited to; planning, production, final and source inspection processes, and traceability/documentation requirements, required

  • At least 5 years of experience in reviewing customer requirements, purchase orders and/or terms and conditions, required

  • Extensive experience interpreting Customer Quality Requirements

  • Demonstrated passion for Continuous Improvement and an understanding of Lean/Six Sigma tools.

  • Leadership skills and the ability to develop the talent of your team

  • Be able to travel domestically or internationally as required


  • US Citizenship or Resident Alien status required to support government programs and projects

  • Travel in support of company objectives as required (5%)

  • Manage continuous improvement project to improve overall quality and efficiency in the department and other areas of the Company (5%)

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Global Quality Assurance / Regulatory Compliance Specialist

Radiometer