NOTE: This position has been filled

The Director of Quality Assurance assures the implementation and continued improvement of the company Quality System; assurance of quality products and processes by establishing and enforcing quality standards and testing materials and products.  Establishes quality and reliability standards by studying product and consumer requirements with other members of management and with production operators, technicians, and engineers and oversees industry-specific practices and ensures all government and company regulations are being met. Their responsibilities include assessing the PhysioLogic Devices’ compliance with industry regulations, both external and internal, developing new policies, and training employees.  Reports to: Chief Executive Officer

TO APPLY: Send Resume/CV and Cover Letter explaining your fit with this position via email to:

Duties and Responsibilities

Strategic Focus Areas

The Quality Assurance Director is responsible for the implementation and oversight of the quality management system, audit and supplier activities

Tactical Responsibilities

  • Develops and implements quality system documentation to ensure compliance with ISO 9001:2015, ISO 13485:2016, and 21 CFR 820 (Quality System Regulation), and other statutory and regulatory requirements, as appropriate.
  • Serves as the management representative for the organization, with responsibility for reporting to top management on the performance of the QMS and for promoting awareness of customer requirements throughout the organization.
  • Serves as the liaison between the company and regulatory authorities (registrar, FDA, OSHA, EPA, etc.) in relation to the Quality System
  • Works with other product realization members to plan and implement new products.
  • Oversees the development of Device Master Records and other product maintenance files ensuring that internal documents and specifications meet customer and regulatory requirements.
  • Schedules and participates in management reviews and internal audits.
  • Oversees the corrective and preventive action program, including determination of corrective actions as a result of internal and external audits.
  • Oversees the testing and measuring/monitoring program, including appropriate calibration of measuring and monitoring equipment.
  • Maintains quality records of objective evidence of compliance with internal and external requirements.
  • Oversees the validation and monitoring of sterilization activities.
  • Assists with or oversees validations as necessary.
  • Oversees the planning, improvement and effectiveness of the quality system.
  • Reviews and approves authorization of temporary product changes as needed.
  • Accesses the limited storage area as needed to evaluate product.
  • Works with other product realization members to plan and implement new products.
  • Coordinates and communicates customer and quality needs in the planning process.
  • Oversees the risk management process.
  • Assures sterile goods follow control requirements during processing of the material/product.
  • Oversees the inspection criteria for incoming raw materials, in-process and finished goods.
  • Assures raw material and finished goods are released according to procedure.
  • Oversees training of all personnel on the QMS, Quality Policy and ISO awareness.
  • Oversees rodent and pest control practices.
  • Has an understanding of the requirements to control customer property.
  • Has an understanding of the product identification and traceability process.
  • Oversees the control of nonconforming product, raw materials and components and dispositions material on hold.
  • Oversees GMP practices and Environmental Control standards.
  • Performs other duties as assigned by the CEO.


  • Can report and/or correct an unsafe practice or condition.
  • Can require non-conforming product to be quarantined.
  • Can request a corrective or preventive action.


  • Leadership
  • Strong written and verbal communication skills
  • Analytic skills
  • Collaboration skills
  • Product management skills
  • QA process skills
  • Ability to read and write technical documents
  • Computer knowledge and skills

Education & Experience Requirements

  • Minimum BA/BS in appropriate discipline from an accredited University
  • Fifteen (15) years’ experience in a Quality position
  • Knowledge of safety requirements and legal standards
  • Working knowledge of quality system requirements
  • PC and knowledge of appropriate software e.g. experience with MS Word, Excel, Project Management and Analytics software
  • Holds a quality-related certification (e.g., CQA, CQM, CQE) or has a minimum of 5 years’ experience with quality management systems
  • Holds Lead Auditor certification
  • Holds ISO 13485:2016 certification
  • Previous experience in a Medical Device industry

Direct Reports

  • Quality Auditing Staff
  • Document Control