[Hiring] Quality Compliance Engineer @Talencio

Role Description

The Quality Compliance Engineer is responsible for maintaining and improving the effectiveness of the Quality Management System (QMS) while ensuring compliance with applicable regulatory requirements, quality standards, and internal procedures. This position owns the Supplier Management program and works cross-functionally with Operations, Engineering, Regulatory Affairs, Manufacturing, and Supply Chain to ensure suppliers, products, and processes consistently meet established quality and regulatory requirements. The role also supports internal, external, and supplier audits; corrective and preventive action; post-market surveillance; recalls and market withdrawals; clinical evaluation reports; risk management; quality metrics; and continuous improvement activities.

Qualifications

• Degree in technical/scientific sciences and 2 years' experience in regulated industry
• Or 5 years' experience in medical device manufacturing environment, minimum of 3 years' experience in Quality role
• Or 8 years in a regulated industry environment, minimum of 4 years in a Quality role

Requirements

• Strong knowledge of QMS and regulated-industry compliance requirements
• 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

Benefits

• Compensation: $90,000 - $100,000

Core Competencies

• Maintain Supplier Management Program including supplier evaluation, qualification, approval, monitoring, re-evaluation, and record maintenance using a risk-based approach
• Oversee supplier audits including planning, execution, documentation, and CAPA lifecycle
• Maintain supplier qualification records, quality agreements, certifications, etc.
• Manage supplier change notifications and second source qualifications
• Monitor supplier quality and performance, prepare supplier 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
• Lead or support investigations involving CAPAs, audit findings, supplier issues, complaints, and other quality events
• Lead complaint intake, assessment, cross functional investigations, documentation, and closure
• Contribute to the assessment, execution, documentation, and regulatory follow-up of recalls and market withdrawals
• Maintain and improve assigned QMS processes, procedures, and records
• Support compliance with ISO 13485, applicable FDA quality system requirements, and other applicable regulations and standards