Director of Quality in Kokomo, IN at Volt

Date Posted: 5/15/2020

Job Snapshot

  • Employee Type:
    Direct Hire
  • Location:
    Kokomo, IN
  • Duration:
  • Date Posted:
  • Job ID:
  • Contact Name
    Volt Branch
  • Phone

Job Description

Director of Quality

This medical company located in Kokomo, Indiana is redefining respiratory care to improve patient outcomes and reduce caregiver challenges in the hospital and home. Ventec's leading product, VOCSN, seamlessly integrates five separate devices including a ventilator, oxygen concentrator, cough assist, suction, and nebulizer into one unified respiratory system. The team's history of patient-centric design includes more than 10 care changing respiratory devices and more than 40 patents. Reports directly to COO. Supervises, trains, and assists all quality team personnel. Directs quality-related activities in conjunction with Manufacturing, Engineering, Supply Chain, Customer Service, and any other department/function that affects the quality of the organization’s goods or services.

Establish policy and provide oversight for staffing, training, and supervision of Quality team members. Assist direct reports in the recruitment and training of personnel. Partners with Ventec’s senior management, R&D, Manufacturing, and Operations management teams to establish strategic plans, identify responsibilities, and organize schedules for the transfer and ongoing management of product to manufacturing including: materials purchase, process development, prototype manufacture, QC requirements, sterility studies, equipment development, scale-up, etc.  Monitor Company performance against the established plan. Responsible for the development, implementation, and strict adherence to a quality program in support of FDA cGMP’s and ISO 13485. Develops and/or reviews standards, policies, and procedures for all functions and departments involved with or related to the production of all products.

The Director of Quality has the ultimate authority and decision over the shipment of any product or products and accepts the responsibility for products being in compliance with all regulatory and company standards. Reviews and resolves quality control problems/concerns with the Quality Control Manager and others including suppliers, vendors, customers, quality control personnel, and any personnel related to production.  Coordinates and assists with vendor inspections. Periodically inspects completed quality control checklists, forms, and other documents; randomly inspects and verifies quality control checks for conformance to prescribed standards. Schedules and performs quality audits and reports findings to the CEO and other division leaders; develops corrective action plans and ensures timely resolution of findings. Prepares reports and other documentation required by regulatory agencies and to support the quality function. Other duties as assigned.

Job Requirements:

 The ideal candidate should possess Bachelor’s degree in engineering, biotech, life sciences, or quality is required. MBA or Master’s degree in a relevant field of science (e.g., bioengineering degree for a bioengineering company) is preferred.

Over 10 years of experience in Quality Assurance/Quality Management in a manufacturing, preferably medical device or highly regulated industry including FDA, CFR and ISO compliance. Lean or Six Sigma expert; or ability to demonstrate strong foundation in process improvement fundamentals. Must have proven ability to lead a diverse team of technicians and engineers. The ideal candidate should be certified in one or more quality-related disciplines (e.g., CQA, CMQ/OE, PMP.

Volt is an Equal Opportunity Employer


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