Director, Quality Assurance
Company: Osprey Medical
Posted on: February 23, 2021
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
- Develops, implements, manages, and integrates a QMS for
- Serves as the primary quality control resource for problem
identification, resolution, loss reporting and continuous
- Assists in the delegation of quality control activity on a
- Supports concurrent engineering efforts by participating in
design development projects representing quality assurance and the
- 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
- Performs root-cause analysis and other problem-solving
activities to identify effective corrective actions and process
- Establishes collection and analysis systems of statistical data
to predict trends that will affect improvement of product
- 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
- Provides final Quality approval on all complaint files.
- Represents Quality in Design Assurance and continuous
- All other reasonable duties, as assigned.
- 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
- Experience with high volume single-use disposables
- Must be self-directed and driven toward being best in
- Excellent interpersonal, organization, computer, and project
- Excellent oral and writing skills to communicate technical
- 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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