Summary
This position will support the maintenance and compliance of the Quality Systems in multiple sites. Responsible for supporting QMS documents updates following the change control process. Support the ASL management and Supplier Qualification process.
Essential Duties and Responsibilities
•Maintains practical knowledge of applicable regulatory requirements.
•Participates in internal audits and external regulatory inspections.
•Participates in the training of colleagues on the requirements surrounding documentation and records management.
•Ensures that documentation is up-to-date and available for use.
•Support records management activities between plant sites to ensure effective and efficient compliance with all applicable laws and regulations.
•Adhere to all safety and health rules and regulations associated with this position and as directed by supervisor.
•Comply and follow all procedures within the company security policy.
•Provide support to all Safety, Health, and Environment (EHS) programs and initiatives to support our zero-accident culture.
•Assists in the preparation for Internal, Customer and External Audits (as required).
•May perform other duties and responsibilities as assigned and trained.
Knowledge Requirements
•MS Office suite (Excel, Word, etc.) mandatory.
•Familiarity with ISO 13485 and FDA QSMR (preferred).
•English proficiency (verbal/written) mandatory.
•Strong interpersonal skills with demonstrated ability to facilitate collaboration.
•Statistics proficiency (preferred).
Education and Experience Requirements
•Associate or BS degree in engineering, business administration or equivalent. Senior college students may be considered as well.
•0-2 years of experience.
•Minimum 6 months work experience (preferred).
