Overview
Quality Assurance Associate – Medical Device – SC Jobs in Columbia, South Carolina Metropolitan Area at Direct Sales Recruiting, LLC
Title: Quality Assurance Associate – Medical Device – SC
Company: Direct Sales Recruiting, LLC
Location: Columbia, South Carolina Metropolitan Area
Quality Assurance Associate – Medical Device
Our client is a well-established and rapidly growing medical device organization developing innovative diabetes-focused technologies designed for physician offices and clinical care teams. They are seeking to hire a Quality Assurance Associate to help ensure the safety, quality and compliance of products. Support validation activity, document control, training and supplier management.
Role reports to an office M-F.
Responsibilities:
- Create and maintain quality records within database; make and approve changes
- Assist with maintaining Design History File and applicable documents
- Provide validation activity support
- Evaluate current suppliers and onboard new suppliers; manage Supplier Corrective Action Requests (SCARs)
- Manage nonconformances; collaborate with suppliers to document and address nonconformances
- Maintain Corrective and Preventive Actions (CAPAs); initiate, investigate and document
- Manage feedback from customers and review, document and investigate complaints
- Onboard new employees; ensure appropriate training and compliance
- Support internal, external and supplier audits
- Track quality data, identifying trends and develop metrics
- Develop process maps and make improvements
Requirements:
- Bachelor’s Degree preferred but not required.
- Min. 1+ years of Quality Assurance experience preferably within the Medical Device and/or Pharmaceutical industry
- Experience with ISO 13485 and FDA Quality System Regulation
- Experience with Quality Management Systems
- Proficient in Microsoft Office suite (Excel and Word)
- Strong written and verbal communication skills
Offering:
- Base Salary $60,000
- Bonus Potential
- Full Benefit Package, 401K
- Growth and advancement opportunities
Direct Sales Recruiting, LLC, (DSR) and DirectHR are National Recruitment organizations partnering with National, Regional and Local Clients to bring qualified candidates a career and a future. DSR offers over 50 years combined Recruitment, Sales and Management experience. We are, along with our clients, an Equal Opportunity Employer and are committed to hiring and supporting a diverse workforce. A M/F/D/V
