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Director, Quality Assurance

Company: Osprey Medical
Location: Minnetonka
Posted on: February 23, 2021

Job Description:

Please note - This position is located in Minnetonka, Minnesota. Remote work is not available for this role.
Osprey Medical, Inc. specializes in the commercialization of proprietary technologies designed to protect CKD patients' kidneys from the harmful effects of dye. Our proprietary technologies reduce the amount of contrast (dye) used during heart catheterization procedures without compromising X-ray image quality for the physician.

  • Our Mission is to improve outcomes in patients with Chronic Kidney Disease by reducing contrast induced Acute Kidney Injury (AKI) and lowering hospital costs.
    • Our Vision is to make heart imaging procedures safer for patients with poor kidney function.
      We are looking for a Director of Quality Assurance to join our team. This person needs to be self-motivated with the ability to establish/maintain a corporate quality assurance system and team; promotes customer satisfaction; and positively impact the financial performance of Osprey Medical. In this roll they will champion continuous improvement efforts and defect reduction initiatives to establish an effective Quality Management System (QMS). The scope of this spans across all the Company's Quality Systems Procedures. They will serve as the Company's Quality Management Representative. They should be a self-starter who likes challenges requiring critical thinking, project management and has keen problem-solving skills. In this role, your work will include activities such as:
      • Accountable to all Quality System compliance across the entire organization of a creative and collaborative team.
      • Initiates and implements quality improvement activities as appropriate (e.g., Kaizen, Six Sigma) to raise the performance of the company's product lines.
      • Strong understanding of all standards and regulations relevant to the Company's products and how to apply them
      • Educates and trains employees as to their impact in the quality management system.
      • Develops, implements, manages, and integrates a QMS for manufacturing.
      • Serves as the primary quality control resource for problem identification, resolution, loss reporting and continuous improvement.
      • Assists in the delegation of quality control activity on a day-to-day basis.
      • Supports concurrent engineering efforts by participating in design development projects representing quality assurance and the customer.
      • Designs, implements, and documents procedures for process control, process improvement, testing and inspection.
      • Establishes and implements metrics (process capability, control charts, measurement quality) for monitoring system effectiveness and to enable managers to make sound product quality decisions.
      • Performs root-cause analysis and other problem-solving activities to identify effective corrective actions and process improvements.
      • Establishes collection and analysis systems of statistical data to predict trends that will affect improvement of product quality.
      • Responsible for the execution of the Quality Management Reviews and related action plans.
      • Collaborate with Process Quality Manager to ensure compliance to all requirements for NCMs, servicing, FGS release, receiving inspections and all other quality driven inspections and internal audits, certifications of conformance approvals, complaint management system and manufacturing process equipment and calibration maintenance.
      • Provides final Quality approval on all complaint files.
      • Represents Quality in Design Assurance and continuous improvement activities.
      • All other reasonable duties, as assigned.
        Minimum Qualifications:
        • BA/BS/MA in technical field or scientific discipline preferred (i.e. engineering, chemistry and physical science).
        • 10 years minimum device industry experience preferred.
        • 10 years minimum direct quality assurance experience with a successful track record.
        • 10 years minimum internal audit/ISO preparation experience
          Skills Required
          • Experience with high volume single-use disposables manufacturing.
          • Must be self-directed and driven toward being best in class
          • Excellent interpersonal, organization, computer, and project management skills.
          • Excellent oral and writing skills to communicate technical information.
          • Demonstrated sound judgment in reviewing technical data, protocols, and applying quality principles.
            We offer a competitive benefits package that includes:--- Medical/Dental/Vision--- Short-Term & Long-Term Disability Coverage, Life Insurance, AD&D--- Health Savings and Flexible Spending Accounts--- Supplemental Plans (Accident, Critical Care, Hospital Indemnity)--- 401k--- PTO and Paid Holidays

Keywords: Osprey Medical, Minnetonka , Director, Quality Assurance, Executive , Minnetonka, Minnesota

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