Essential Duties & Responsibilities:
- Manages all quality systems within the Diagnostics manufacturing division to meet required standards as defined in the company Quality Manual, ISO 9001, ISO13485, ISO14971, 21 CFR 820, In vitro Diagnostic Regulations, and other standards, as applicable.
- Manages Diagnostics Operations in QA activities (all document control functions, management reviews, risk assessments, audits, and calibrations/validations) to provide consistency and framework in Quality Assurance. Manages the awareness of customer requirements to appropriate staff.
- Manages the manufacturing Quality Systems and makes recommendations for continuous improvements; ensures Quality functions are performed appropriately and consistently and on schedule.
- Manages the CAPA Management System (including investigations, corrective actions, preventative actions) and monitoring the CAPA system.
- Ensure that quality requirements are met for the release of all manufactured products and incoming raw materials. Responsible for final release of all manufactured products.
- Liaise with regulatory agencies and customers QA / regulatory affairs department, as needed. To include handling of product recalls, notifications and maintenance of all licenses, permits, certificates.
- Lead and perform quality audit program to include groups supplier audits.
- Acts as the designated management representative.
- Responsible for training relevant staff on quality requirements.
- Any other responsibilities/duties as requested by management.
Education & Requirements:
- 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
Skills:
- 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. Ability to articulate clearly and document conversations
- To perform this job successfully, an individual should have knowledge of the MS family or software.
This job requires the individual to be fully vaccinated against COVID-19, absent a legally required accommodation, as required by Executive Order 14042 and the Safer Federal Workforce Task Force COVID-19 Workplace Safety: Guidance for Federal Contractors and Subcontractors.
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. |
