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Quality Engineer - Medical Device

Hybrid Role: 3-4 days a week onsite in Columbia, SC

• Company will provide some relocation assistance

Growing medical device manufacturer is looking to add an engineer to their quality team. The Quality Engineer is responsible for supporting and maintaining the Quality Management System (QMS) to ensure compliance with applicable medical device regulations, industry standards, and company quality objectives. This role partners cross-functionally with Manufacturing, Engineering, Regulatory Affairs, Operations, Suppliers, and Customers to drive product quality, process improvement, risk management activities, and regulatory compliance throughout the product lifecycle

.The Quality Engineer contributes to quality planning, validation activities, supplier quality management, investigations, corrective and preventive actions, and continuous improvement initiatives while supporting global regulatory requirements and market access

.Essential Duties and Responsibilitie

sQuality Management Syste

• mSupport the development, implementation, and continuous improvement of the Quality Management System (QMS)
• .Ensure compliance with applicable medical device regulations and standards, including ISO 13485 and FDA 21 CFR Part 820
• .Assist in maintaining quality procedures, work instructions, and controlled documentation

.Risk Managemen

• tLead and maintain product and process risk management activities in accordance with ISO 14971
• .Facilitate risk assessments and support mitigation planning throughout the product lifecycle
• .Ensure risk management documentation remains current and compliant

.Supplier Quality Managemen

• tMonitor supplier quality performance and support supplier qualification activities
• .Participate in supplier audits, corrective action reviews, and quality improvement initiatives
• .Evaluate supplier-related nonconformances and drive resolution efforts

.Product Quality and Validatio

• nSupport validation activities, including process validations, sterilization validations, software validation, and equipment qualification
• .Review and approve validation protocols, reports, and associated documentation
• .Develop and implement testing methodologies to ensure product performance and compliance

.Investigations and CAP

• ALead and support investigations related to nonconforming products, customer complaints, and quality system issues
• .Conduct root cause analyses and implement corrective and preventive actions (CAPA)
• .Monitor effectiveness of corrective actions and ensure timely closure

.Design and Regulatory Suppor

• tReview design control documentation, labeling, specifications, and technical files for compliance with applicable requirements
• .Collaborate with Engineering and Regulatory Affairs during product development and design change activities
• .Support product submissions and compliance requirements for global markets

.Audits and Complianc

• eParticipate in internal, supplier, customer, and regulatory audits
• .Assist in preparation for external inspections and audits
• .Address audit findings and support implementation of corrective actions

.Continuous Improvemen

• tIdentify opportunities for process improvement, quality enhancement, and operational efficiency
• .Participate in cross-functional projects focused on quality and performance improvement
• .Utilize data analysis and quality tools to drive informed decision-making and process effectiveness

.Required Qualification

• sBachelor's degree in Engineering or a related technical discipline
• .Experience working within a regulated medical device or pharma environment
• .Working knowledge of ISO 13485, FDA 21 CFR Part 820, and applicable quality system requirements
• .Understanding of risk management principles and methodologies, including ISO 14971
• .Experience supporting validation activities, investigations, CAPA processes, and quality systems
• .Strong analytical, problem-solving, and organizational skills
• .Effective written and verbal communication skills
• .Ability to work independently and collaboratively within cross-functional teams

.Preferred Qualification

• sCertified Quality Engineer (CQE)
• .Certified Reliability Engineer (CRE)
• .Project Management Professional (PMP) certification
• .Lean Six Sigma certification
• .Experience with supplier quality management and audit participation
• .Knowledge of sterilization validation and software validation processes
• .Experience supporting global regulatory compliance requirements

.Knowledge, Skills, and Abilitie

• sKnowledge of medical device quality systems and regulatory requirements
• .Ability to conduct root cause investigations and implement corrective actions
• .Proficiency in quality tools, statistical analysis, and data-driven decision-making
• .Strong project management and organizational capabilities
• .Ability to interpret technical specifications, procedures, and regulatory requirements
• .Strong interpersonal skills with the ability to collaborate across departments and with external stakeholders

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