To ensure compliance to FDA ISO, and various regulatory requirements through management of Document Control, Product Release, Internal audits, and CAPA systems. Supports applicable regulations including International, Local, State, and/or Federal requirements.
- Ensure the facility is in compliance to ISO13485, IVDD, CMDCAS, and QSR requirements.
- Provides a leadership role in the effort to promote continuous improvement of Quality System processes.
- Develops, monitor and meet, department and individual goals & objectives.
- Creating a sense of urgency and helping team to deliver projects and activities to agreed upon deadlines.
- Manage the manpower, equipment and resources for effective operations.
- Oversee the internal quality audit system.
- Oversee the CAPA system as it relates to universal issues.
- Oversee the document control system.
- Oversees the training system
- Oversee the product release process
- Generate key performance indicators and Support Management
- Review process.
- Follow corporate policies and procedures.
- Participates/supports in the audits of third party audits.
- Supervises Employees.
- Requires 4 or more years working experience in the healthcare industry.
- Requires supervisory experience. Other relevant experience may be considered.
- ASQ Certified Auditor a plus.
- Working knowledge of Industry related Quality Systems, Medical Device QSRs, familiarity with International Quality Standards.
- Ability to read, analyze, and interpret general business periodicals, professional journals, technical procedures, or governmental regulations.
- Ability to write reports, business correspondences, and procedure manuals.
- Ability to effectively present information and respond to questions from groups of managers, clients, customers, and the general public.
- Ability to apply advanced mathematical concepts such as exponents, logarithms, quadratic equations, and permutations.
- Ability to apply mathematical operations to such tasks as frequency distribution, determination of test reliability and validity, analysis of variance, correlation techniques, sampling theory and factor analysis.
- Ability to define problems, collect data, establish facts, and draw valid conclusions.
- Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables.
Languages Fluent spoken and written English