Director, Quality Assurance

Overview

About Shifamed

Description

Responsibilities, Skills & Hands-On Experience

• Ensure compliance with applicable Quality System Regulations and standards, including FDA QSR, ISO 13485, MDR, GMP, and Design Controls.
• Partner with R&D and Operations to establish and maintain quality requirements throughout product development, transfer, manufacturing, and post-market activities.
• Lead and maintain Design History Files (DHF), Risk Management Files, and associated quality documentation for products and processes.
• Develop and implement quality engineering activities including design verification/validation, process validation, equipment qualification, test method validation, and first article inspections.
• Support manufacturing quality activities including inspection processes, nonconformance investigations, CAPA, root cause analysis, and continuous improvement initiatives.
• Develop, maintain, and oversee manufacturing and quality documentation including procedures, inspection instructions, Lot History Records, and Bills of Materials.
• Manage supplier quality activities including supplier qualification, audits, source inspections, supplier controls, and ongoing quality performance monitoring.
• Prepare for, host, and support internal, customer, supplier, and regulatory audits and inspections.
• Coordinate quality system training and promote company-wide quality system awareness and compliance.
• Support complaint handling, MDR/vigilance reporting, field actions, and investigation of product or process failures.
• Serve as Quality representative on cross-functional project teams and act as site Management Representative and/or Quality signature authority as required.
• Lead and manage Quality Assurance resources to ensure effective execution of quality system and regulatory compliance activities.
• Other duties as assigned.

Education & Work Experience

• Bachelors or Masters in Engineering or scientific discipline, or equivalent relevant work experience
• 15+ years of Quality or Technical Management experience in the medical device industry or a related field.
• Previous direct people management experience.
• Previous experience bringing a company into regulatory compliance and approval, preferred.
• Solid knowledge of FDA regulations and interpretation of FDA regulations, guidelines, and policy statements.
• Solid knowledge of international regulations, standards, and guidelines (i.e. MDR, ISO 13485, ISO 14971, IEC 60601 and collateral standards, IEC 62304, IEC 62366, FDA guidance documents for cybersecurity).
• Ability to train others in processes and procedures.
• Excellent communications skills (both written and verbal) required.
• Ability to work effectively across functional lines to reach effective outcomes for the business.
• Ability to travel as required.
• Our salary ranges are calculated by role, level, and location.
• Please note that your position within that range will be determined by your job-related knowledge, location, skills, experience, relevant education, and training/certifications.
• NOTICE TO CANDIDATES: Please be aware that Shifamed and its portfolio companies do not conduct interviews or extend offers through mobile web chat applications.
• Please report any such occurrences to hr@shifamed.com.