Position Overview

Leads the Operations Quality departments, including Quality Engineering, Quality Inspection, labeling development, sterilization validation, packaging / shipping validation and Metrology. Ensures regulatory compliance to applicable domestic and international requirements. Integrates activities associated with receiving inspection, in-process inspection, finished product inspection, and product support quality engineering. Works closely with Manufacturing, R&D, Regulatory Affairs and other Quality Assurance areas to support manufacturing process changes, product design transfers, product sustaining projects and continuous improvement of Operations Quality. Job duties:
  • Directs all aspects of the Operations Quality function including Quality Engineers, Quality Control, Metrology, labeling development, sterilization validation, and packaging / shipping validation in compliance with FDA regulations, company SOPs and other applicable standards.
  • Prepares annual department budget, staffing requirements and objectives for Operations Quality. Defines objectives to support company goals.
  • Leads prevention-oriented quality improvement programs in order to meet company quality goals and objectives.
  • Leads efforts to establish Operations Quality procedures for all stages of product realization compliant to FDA regulations, ISO 13485 and applicable standards.
  • Leads efforts for quality reporting of product-related quality and performance data and applies statistical methods to proactively identify product quality issues and trends. Initiates Corrective and Preventive Actions to ensure product quality and compliance.
  • Reviews and approves procedures designed to ensure successful testing of critical components, sub-assemblies and assemblies for conformance to specifications and standards.
  • Leads teams who provide technical services to R&D and Sustaining Engineering for equipment/tooling qualification and process validation.
  • Leads training programs designed to develop and increase employees’ quality skillset, including statistical techniques.
  • Remains informed about developments and trends in quality control and makes recommendations for appropriate corrective actions.
  • Ensures the quality policy/system is planned, understood, implemented and maintained within the department.
  • Ensures departmental compliance as well as appropriate departmental resources are available to effectively maintain the quality system.
  • Performs additional duties as assigned.

    1. Bachelor’s Degree in science or engineering.
    2. Minimum ten (10) years of engineering experience in the medical device industry.
    3. Five (5) years of management experience.
    Desired Qualifications
    1. Knowledge of US and foreign regulations relative to the design, manufacturing, distribution and servicing medical devices; quality system and other standards for the medical device industry.
    2. Excellent written and verbal communications.
    3. Reading and preparing technical documentation.
    4. Good interpersonal skills.
    5. Excellent management skills with ability to assign and monitor work.