Job Title: Engineer - Complaints
Location: San Diego, CA
Contract length: 6 months
Schedule: Fulltime, 8a to 5p
Pay: $55/hr to $59.87/hr, DOE

Job Overview:
Our client's products must comply with the regulatory requirements applicable to medical devices for the markets in which they are sold. Their products are marketed based on a reputation of high quality. The Post Market Surveillance (PMS) team supports their products sold to the global market and overall strategy to maintain quality, safety, cybersecurity, customer satisfaction, and business ethics while supporting profitable growth. The primary quality deliverable of The Complaint Handling Team, which forms part of The PMS Team, is the management of the complaint handling and vigilance processes, ensuring internal processes and systems are aligned to regulatory requirements and industry standards while maintaining compliance and efficiency of complaint workflows.

Job Responsibilities:

• Regional escalated complaint intake, including reviewing incoming complaints for completion and accuracy in a timely manner
• Regional and global reportability assessments, ensuring regulatory compliance
• Regional drafting and submitting of vigilance reports to relevant regulatory authorities, ensuring regulatory compliance
• Drafting and sending customer responses to escalated complaints
• Act as an escalation point for regulators and customer issues in region, including working with appropriate stakeholders to support the resolving of product quality issues through their quality escalation process
• Participate in preparation for audits, ensuring compliance and readiness. SME during internal and external audits to demonstrate the effectiveness of the complaint handling and vigilance processes and systems
• Support the maintenance of procedures in accordance with their Quality Management System

• Proven ability to operate effectively within a global quality and regulatory ecosystem
• Strong understanding of international medical device complaint and vigilance requirements (e.g., FDA, EU MDR, Health Canada, ANVISA, TGA)
• Experience supporting global inspections or MDSAP audits
• Ensuring the escalation process is working effectively to manage risk
• Demonstrate initiative in managing rapidly evolving quality and regulatory issues where data and outcomes are often unclear
• Independent self-direction and excellent organizational skills
• Good conceptual thinking ability
• Good problem-solving and analytical abilities
• Continuous improvement mindset 
• Strong verbal and technical writing skills
• Good planning and time-management skills

• Minimum Qualifications
  • Engineering/Science degree or equivalent
  • Complaint handling experience, including vigilances
• Preferred Qualifications
  • Formal training in Quality Systems or Six Sigma
  • Experience in an ISO, MDSAP, or EU MDR certified quality-driven industry or equivalent experience