Quality Compliance Engineer

Rhythmlink International LLC•Columbia, SC

1d•$85,000 - $100,000

About The Position

The Quality Compliance Engineer maintains and improves the effectiveness of the Quality Management System (QMS) and ensures compliance with applicable regulatory requirements, quality standards, and internal procedures. The role owns the Supplier Management program and works cross-functionally with Operations, Engineering, Regulatory Affairs, Manufacturing, and Supply Chain to ensure suppliers, products, and processes meet established quality and regulatory requirements. The position supports internal, external, and supplier audits; corrective and preventive action; complaint management; post-market surveillance; recalls and market withdrawals; clinical evaluation reports; risk management; quality metrics; and continuous improvement activities. It maintains assigned QMS processes, procedures, and records and provides quality and compliance guidance for supplier, product, process, and system changes.

Requirements

A degree in technical or scientific sciences and 2 years of experience in a regulated industry; or 5 years of experience in a medical device manufacturing environment, including at least 3 years in a Quality role; or 8 years in a regulated industry environment, including at least 4 years in a Quality role.
Strong knowledge of QMS and regulated-industry compliance requirements.
Working knowledge of supplier qualification, supplier monitoring, supplier auditing, supplier corrective action, and quality agreements.
Ability to apply risk-based thinking, root cause analysis, and quality engineering principles.
Ability to analyze data, identify trends, and communicate conclusions clearly.
Strong written communication, technical writing, organization, project management, and follow-up skills.
Ability to manage multiple priorities and work independently while maintaining attention to detail.
Ability to collaborate effectively with Operations, Engineering, Manufacturing, Supply Chain, Regulatory Affairs, and other functions.
Ability to travel periodically for supplier audits or other business needs.
Ability to use office equipment, including a phone, copier, and computer.
Ability to sit for extended periods at a desk.
May be required to lift items weighing up to 15 pounds.

Nice To Haves

Experience conducting internal or supplier audits.
Experience applying ISO 13485, QMSR, EU MDR, and/or MDSAP.
Experience with CAPA, change control, complaint handling, supplier management, or risk management.
Professional quality or auditing certification, such as ISO 13485 Lead Auditor, ASQ CQE, CQA, or equivalent, or Lean Six Sigma.

Responsibilities

Maintain the Supplier Management Program, including risk-based supplier evaluation, qualification, approval, monitoring, re-evaluation, and record maintenance.
Oversee supplier audits, including planning, execution, documentation, and the CAPA lifecycle.
Maintain supplier qualification records, quality agreements, certifications, and related documentation.
Manage supplier change notifications and second-source qualifications.
Monitor supplier quality and performance and prepare performance and re-evaluation summaries for the Supplier Qualification Team and Management Review, as applicable.
Conduct internal, external, and supplier audits, including preparation, reporting, and closure.
Maintain auditor qualifications and audit documentation.
Lead or support investigations involving CAPAs, audit findings, supplier issues, complaints, and other quality events.
Facilitate cross-functional root cause analysis and risk-based CAPA actions using quality tools, and drive timely completion and verification of effectiveness.
Lead complaint intake, assessment, cross-functional investigations, documentation, and closure.
Analyze complaint, clinical, regulatory, and product performance data for recurring issues, emerging risks, trends, regulatory escalations, and corrective-action triggers.
Collaborate on regulatory reporting and responses where applicable.
Maintain post-market surveillance plans and reports, including Post Market Surveillance Reports, Periodic Safety Update Reports, and Summary Reports, as applicable.
Ensure post-market information is incorporated into risk management, CAPA, and Management Review activities when required.
Maintain clinical evaluation plans and reports.
Contribute to the assessment, execution, documentation, and regulatory follow-up of recalls and market withdrawals, performing assigned tasks where applicable.
Maintain and improve assigned QMS processes, procedures, and records.
Support document and record control, training, change control, gap assessments, risk management, and electronic quality system validation, as assigned.
Develop, analyze, and report quality metrics, objectives, and key performance indicators.
Provide quality and compliance guidance for supplier, product, process, and system changes.
Use quality data and risk-based methods to identify risks and improvement opportunities.
Collaborate with Operations, Engineering, Manufacturing, Supply Chain, Regulatory Affairs, and contract manufacturers to improve compliance, efficiency, supplier performance, and product quality.
Support compliance with ISO 13485, applicable FDA quality system requirements, and other applicable regulations and standards.
Travel periodically for supplier audits and other business needs.