*Assuring the conformance of all organization's regulatory and quality systems requirements.
*Performing internal audits to verify compliance and conformance to all regulatory and quality systems requirements, including both Customer and Flex mandated.
*Engage in External Audit Processes (Customers', Regulatory, Government Agencies, etc.)
*Verify the proper implementation and effectiveness of the applicable Regulations, Standards, Policies, Directives and Level 1 Procedures in the organization
*Provide support to any area that requires help to implement regulatory and quality requirements into their processes.
*Develop training programs for internal users in subjects related to Regulations or Quality Systems
*Execute the formation of Regulatory and Quality Systems skilled employees that help support the organization.
*Develop Internal / External Audits Programs
*Prepare the Audit Plan and related Audit Checklists
*Execute Audits according to the plan, prepare the audit reports and maintain all audit related records.
*Plan, execute and follow up any Area/Process Audit when required by the organization
*Create audit reports that identify any Non-Conformance or Opportunities for Improvement found during the audit process.
*Document all audit findings and request the corrective / preventive actions needed
*Participate as a key member for all external audits activities and maintain records as required.
*Follow up on internal and external corrective actions to ensure timely implementation and validate their effectives.
*Stay up-to-date on New/Revised Regulations, Standards, Policies, Directives and Level 1 Procedures
Knowledge / Skills / Abilities:
*Use of the following knowledge/skills may be required:
*Must have knowledge of relevant regulatory standards and applicable regulations.
*Regulatory And Quality Audits Process
*Regulations And Quality Standards ( ISO13485, FDA 21 CFR 820/11),
*Internal Quality Systems Manuals and Level 1 Procedures,Manufacturing Processes,Regulatory Agencies,Project Management.
*Ability to read and interpret documents such as safety rules, operating and maintenance instructions and procedure manuals.
*Ability to write routine reports and correspondence.
*Ability to communicate effectively with employees of organization.
*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.
Certificates, Licenses, Registrations:
Scope / Impact:
*Impacts operations of immediate work group. Executes and may provide input to functional processes or technologies. Assists in achieving section/sub-function objectives for a functional area. Carries out functional initiatives.
Decision Making / Discretion:
*Limited decision-making opportunities or responsibilities; makes guided or scenario-based decisions requiring management approval. Provides input for team decisions. Decisions affect team
Supervision / Leadership:
*Closely supervised, normally receives detailed instructions on all work. Identifies own development needs and works toward them. Assimilates Flex values
*While performing the duties of this job, the employee is frequently exposed to risk of electrical shock. The employee is occasionally exposed to moving mechanical parts.
*While performing the duties of this job, the employee is frequently required to talk and hear. The employee is occasionally required to stand, walk, sit, handle small components and reach with hands and arms. The employee must occasionally lift and/or move up to 25 pounds. Specific vision abilities required by this job include close vision, and depth perception.
The information we collect:
We may collect personal information that you choose to submit to us through the Website or otherwise provide to us. This may include your contact details; information provided in online questionnaires, feedback forms, or applications for employment; and information you provide such as CV/Resume. Your details will be provided to the entity you are applying for a job with. We will use your information for legitimate business purposes such as responding to comments or queries or answering questions; progressing applications for employment; allowing you to choose to share web content with others or; where you represent one of our customers or suppliers, administering the business relationship with that customer or supplier. We will process your data in accordance with our Recruitment Privacy Notice.
If you have any queries about the processing of your data, please contact:
Global Data Privacy Officer:
Email Address: email@example.com
Apply on company website