Job Duties:

• Acts as the designated management representative.

• Manages all systems within the Diagnostics manufacturing division to meet required standards as

defined in the Company quality Manual, ISO 9001, ISO13485, ISO14971, 21 CFR 820, 21 CFR 600

series, European Medical Devices Regulations, and other regulatory standards, as applicable.

• Manages compliance to all safety and regulatory requirements in accordance with State/Federal

regulations or any other regulatory agency and for any applicable certification required to maintain

the certification.

• Manages the manufacturing Quality Systems and makes recommendations for continuous

improvements; ensures Quality functions are performed appropriately and consistently and on

schedule.

• Responsible for the training of relevant staff on RAQA /Safety requirements.

• Liaise with all management on resources necessary for the satisfactory operation of the Quality

Systems.

• Manages the CAPA Management System (including investigations, corrective actions, preventative

actions, and monitoring the CAPA system.

• Manages the release of all products for distribution.

• Manages Diagnostics Operations in QA activities (document control, management reviews, risk

assessments, and calibrations/validations) to provide consistency and framework in Quality

Assurance. Manages the awareness of customer requirements to appropriate staff.

• Ensure applications for the regulatory applications/submissions are completed in a timely manner.

• Ensure that quality requirements are met for the manufacturing and domestic/international release

(for import and export) of products.

• Liaise with regulatory agencies and customers regulatory affairs department, as needed.

• Maintains all licenses, permits, certificates, etc. that relate to the Diagnostic business.

• Handles product recalls, consignee notifications etc.

• Perform all Document Control functions (including review, approval, processing, and distribution of

controlled documents).

Skills:

• To perform this job successfully, an individual should have knowledge of the MS family of software.

• Ability to read, and comprehend simple instructions, short correspondence and memos.

• Ability to correspond effectively with customers and regulatory agencies.

• Ability to effectively present information in one-on-one and small group situations to customers, clients and other employees of the organization.

• Ability to add, subtract, multiply and divide in all units of measure, using whole numbers, common fractions and decimals.

• Possesses excellent self direction, critical thinking, and innovative thinking. Must be detail oriented have excellent analytical, interpersonal, and organizational skills.

Education & Requirements:

• Associates Degree required; Bachelor's degree from a four-year college or university preferred and three to four years related experience and/or training in a medical device manufacturing environment required.

• Must be able to travel 10% of the time.

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, citizenship, disability or protected veteran status.