POSITION TITLE: QA/QC Senior Manager or Director
DEPARTMENT: Quality Assurance
REPORTS TO: CEO
JOB STATUS: Exempt
Imagine ordinary healthcare workers or first responders conducting sensitive nucleic acid tests in a near-patient setting or in the field by simply collecting a sample into a test tube, inserting the tube into a handheld analyzer, and getting the test results within 30 minutes, without further human intervention. IQuum’s Liat™ Analyzer makes this vision a firm reality.
I. JOB SUMMARY:
Lead all aspects of quality assurance and quality control across all functions of the organization.
Establish and maintain quality controls and documentation procedures; DCO, CAPA, NCR and other processes.
Proactively and passionately lead and manage all aspects of the Company’s Quality Management System to comply with rigorous requirements of ISO 13485, FDA regulations for medical devices and other applicable global standards and regulations to support the Company’s rapid growth plans.
Interact extensively with manufacturing, biology, engineering, purchasing, finance and executive management to provide world class quality assurance leadership and compliance for all functions of the Company aligned with strategic goals and operational objectives.
Manage and maintain the Company’s quality inspection and product release programs for incoming and in-process materials and components, processes and finished goods.
Monitor quality and customer service performance by gathering relevant data and producing statistical reports; establish standards of world class customer service and customer satisfaction for customers or clients.
Defining quality metrics, analyze performance data against defined parameters.
Set QA/QC compliance objectives and ensure that targets are achieved. Conduct QA compliance audits of products and processes.
Ensure manufacturing tests and procedures are properly understood, evaluated, completed and documented and product modifications are investigated as necessary.
Work with purchasing staff to establish quality requirements from external suppliers; review product and process non-conformance and recommend remedial actions including but not limited to modifications of processes, products or QA standards where warranted.
Ensure that all QA department personnel are trained to perform their jobs effectively and manage the QA departmental budget and other administrative functions to ensure an efficient operation that is cost effective and well integrated.
Maintain acute awareness of the business strategy and financial goals.
EDUCATIONAL REQUIREMENTS: Bachelors of Science Degree required; Engineering or Biology or related concentration preferred.
OTHER REQUIREMENTS:
12-15+ years of relevant quality assurance and quality control management experience.
Must have extensive ISO 13485 experience and applied knowledge and capabilities for FDA requirements for medical device company.
Demonstrated ability to use good judgment in technical matters relating to problem solving or product or production difficulties.
Demonstrated understanding of the functional processes, product and customer base.
Successful candidate must possess the ability to lead QA/QC compliance in a fast-paced and exciting environment and work in both team and independent modes.
Candidate must have a positive and winning attitude and strong leadership skills.
CONTACT: Send resume and salary history and requirements to Daniel J. Sutherby, CPA, Chief Financial Officer; [email protected] 508-970-0099, x 120
Imagine ordinary healthcare workers or first responders conducting sensitive nucleic acid tests in a near-patient setting or in the field by simply collecting a sample into a test tube, inserting the tube into a handheld analyzer, and getting the test results within 30-60 minutes, without further human intervention. IQuum’s Liat™ Analyzer makes this vision a firm reality. IQuum has developed a novel biological sample testing technology that is intended to provide revolutionary benefits to a broad cross section of the bioassay market. Our proprietary lab-in-a-tube technology will enable the less experienced personnel to perform more sophisticated biological sample testing in a less expensive setting with greater speed. We believe that our lab-in-a-tube platform is the foundation of next generation tools for clinical diagnostics, therapeutic monitoring, biodefense, and agricultural and industrial biological sample testing. About the Liat™ Analyzer The Liat system refines the testing process to three simple steps: (1) collecting a raw biological sample into a Liat Tube, (2) scanning the tube’s barcode to identify the test and track the patient sample, and (3) inserting the tube into the Liat Analyzer. The analyzer automatically executes all the required assay steps and reports test results on the built-in touch screen. No manual reagent addition, operator intervention or data interpretation is required. The Liat Analyzer’s small size (~4.3” x 8” footprint), fully integrated and self-contained design, along with its closed tube design and robust error prevention features, will make it ideally suited for future tests near-patient or on-site molecular diagnostics. IQuum’s ultimate goal with the Liat system is to enable nucleic acid tests to be conducted rapidly and reliably by non-specialized personnel at the near patient or other decentralized settings.
IQuum, Inc. is an Equal Opportunity Employer. This company does not and will not discriminate in employment and personnel practices on the basis of race, sex, age, handicap, religion, national origin or any other basis prohibited by applicable law. Hiring, transferring and promotion practices are performed without regard to the above listed items.
