Director of Quality - Rye Brook, NY

Job Functions, Duties, Responsibilities and Position Qualifications :

Before applying for this role, please read the following information about this opportunity found below.

Quality is in our DNA, is it in yours?

Sonic Healthcare USA (SHUSA) has an exciting opening for a Director of Quality in our Rye Brook, NY location.

Join our dynamic team as the Director of Quality and lead the charge in maintaining and enhancing our state-of-the-art Quality Management System (QMS) for our cutting-edge clinical and anatomic pathology laboratories.

In this pivotal role, you will be at the forefront of ensuring top-tier regulatory accreditation and compliance with organizations like the College of American Pathologists (CAP) and the New York State Department of Health.

You will drive continuous improvement initiatives across all departments using innovative techniques like Lean and Six Sigma, while also overseeing critical programs such as document control, internal audits, and non-conforming events management.

As a key player in the development of FDA cleared tests and laboratory-developed tests, you will ensure our standards are second to none.

Bring your expertise in clinical or anatomic pathology laboratories and collaborate with our leadership team to shape and implement essential quality indicators that set new benchmarks for excellence.

Location : Rye Brook, NY

Days : Monday - Friday

Full-time : Benefit Eligible

Salary : $155-180K (depending on experience)

Essential Job Duties :

• Ensure that all systems, processes and testing procedures are compliant with CAP, CLIA, New York Standards and other federal, state and regulatory agencies' requirements.
• Manage all aspects of the Quality Management Department including preparing for inspections, performing mock inspections, coordinating quality improvement programs, recording accurate and complete documentation.
• Responsible for administering the laboratory document control system.
• Responsible for creating and maintaining all SOPs related to safety, general laboratory policies, and quality management.
• Responsible for regulatory and accreditation applications and the creation of corresponding policies and procedures.
• Conduct laboratory quality improvement meetings and ensure minutes are generated and maintained from each. Follow up on all action items generated from meetings.
• Function as a resource / subject matter expert for the lab safety officer.

Want to help get your resume to the top? Take a look at the qualifications and experience we require :

• EDUCATION : B.S. in science-related field (required); Certification as MT, CLS, CT, HT or HLT (ASCP) is desirable; MHA / MBA (preferred)
• EXPERIENCE : 7+ years of laboratory management and quality management experience required. Previous clinical or anatomic pathology bench experience required.

Experience with NYSDOH, CLIA, and CAP required. Experience with state licensure preferred.

KNOWLEDGE, SKILLS AND ABILITIES : The ability to communicate effectively both orally and written. The ability to coordinate multiple resources effectively.

Accountable and self-directed. Takes initiative and work independently and within a team. Attention to detail and accuracy.

LICENSE / CERTIFICATION (REQUIRED / PREFERRED) : ASQ Lean Six Sigma & ASCP generalist certification preferred. Auditor training preferred.

Scheduled Weekly Hours : 40

Work Shift :

Job Category : Laboratory Operations

Company : Sonic Healthcare USA, Inc

Sonic Healthcare USA is an equal opportunity employer that celebrates diversity and is committed to an inclusive workplace for all employees.

We prohibit discrimination and harassment of any kind based on race, color, sex, religion, age, national origin, disability, genetics, veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state, or local laws.

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