Permanent position: Quality Compliance Specialist needed at rapidly growing manufacturing plant located in West Columbia, SC. This is a day shift role. APPLY NOW!Responsibilities for the Quality Engineer
Requirements for the Quality Engineer
- Assure the conformance of all organization's regulatory and quality systems requirements.
- Site admin for QDMS system
- Site contact for all regulatory audits..
- Perform internal audits to verify compliance and conformance to all regulatory and quality systems requirements
- 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.
- 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.
- Knowledgeable and experienced on Quality Management Systems (QMS).
- Must have medical device experience and be knowledgeable in ISO 13485
- Knowledgeable and experienced in performing internal audits.
- Site liaison, coordinator, lead for all current and future regulatory agencies.
- Full range of medical benefits, dental, vision
- Life Insurance
- Matching 401K
- Tuition Reimbursement
- Employee discounts at local retailers
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.