Quality Assurance – Medical Device – Columbia, SC

Quality Assurance – Medical Device

Resumes to: Careers@directhr.com

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 Engineer to ensure the safety, quality and compliance of products. Support design control, product manufacturing, risk management and supplier management.

Responsibilities:

• Maintain and ensure compliance of Quality Management System
• Assist with design control activities; reviews, verification, validation and risk management
• Maintain design and development files, review and update as needed
• Collaborate with multiple depts. to ensure adherence to quality standards and compliance requirements throughout all stages of the product lifecycle
• Perform quality lab activities to include product testing and investigations
• Review, assess, and approve quality records (i.e. change orders, deviations, validation documents and complaints, etc.)
• Assist with inspections and audits as well as supplier qualifications and other supplier quality management activities
• Lead root cause investigations, implementing corrective and preventive actions
• Track and analyze quality metrics, identifying trends and make recommendations for improvement

Requirements:

• Bachelor’s Degree in Engineering
• Min. 3+ years of Quality Engineering experience within Medical Device
• Wearable product experience a plus
• Knowledge/Understanding of ISO 13485 and FDA 21CFR820 as well as other relevant standards/regulations
• Knowledge/Understanding of Quality Engineering and Validation principles
• Experience with Quality Management Systems, Design control and risk management tools
• Strong Communication skills

Offering:

• Base Salary $130,000 – $150,000 (based on experience)
• Bonus Potential
• Full Benefit Package, 401K and Equity

Resumes to Careers@directhr.com

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