Product Surveillance Specialist

Job description / Role

Responsibilities:
• Key contributor as part of a complaint handling unit
• Developing and implementing methods and procedures for effective trending of complaints
• Facilitating complaint investigation
• Engaging product design owners to determine effective CAPA
• Identifying complaints that represent further evaluation under 21CFR Part 803 (MDR)
• Reviewing appropriate criteria for closure of complaints
• Owning and communicating metrics on status
• Continuously working to improve the process

Quality Specific Goals:
• Aware of and comply with the GEHC Quality Manual, Quality Management System, Quality Management Policy, Quality Goals, and applicable laws and regulations as they apply to this job type/position
• Complete all planned Quality & Compliance training within the defined deadlines
• Identify and report any quality or compliance concerns and take immediate corrective action as required

Benefits:
• Attractive Salary Package

Requirements

Qualifications/Requirements:
• Bachelors degree in engineering or health sciences field; or a High School diploma/GED and minimum 2 years work experience in a Quality or Regulatory Assurance related field

Desired Characteristics:
• Minimum 1 year experience in medical device or pharmaceutical industry in an Engineering, Quality or Regulatory related role
• Product-specific knowledge
• Demonstrated knowledge of 21CFR Part 820
• Ability to demonstrate GEHC Growth Values
• Demonstrated experience prioritizing conflicting demands in an extremely fast paced environment
• Ability to work independently & in a team setting
• Excellent verbal, written, and presentation skills with the ability to communicate business issues clearly in English (and where appropriate, be able to communicate in the local language verbally and in writing)
• Excellent interpersonal, organizational, and influencing skills
• Familiarity with the application of medical device as it relates to patient safety
• Ability to analyze and process data, and draw the appropriate conclusions
• Experience working with cross-functional teams and facilitating teams to identify and implement solutions to complex problems
• Ability to analyze and process data, and draw the appropriate conclusions
• Experience working with cross-functional teams and facilitating teams to identify and implement solutions to complex problems
• Prior experience working with Microsoft Office products
• Working knowledge of GEHC products

About the Company

Dragon Recruiting is a leading international staffing and recruitment company, head-quartered in London, with further offices all over the globe. Our clients range from numerous well known UK and international businesses. We also represent a wide range of less well known clients - helping them to find staff for their businesses around the world.

As an international recruitment agency, our clients benefit from a vast network of human resource specialists who attract, cultivate and connect organisations to talent in both global and local markets. Our unrivalled

scope of services and global reach allow us to share candidates and roles across borders. With greater coverage and tools, we can ensure our clients and candidates all get the best outcome for their recruitment needs.

With experience of over 3 decades we are recruiting more than 10,000 workers annually to and from the UK, USA and the Middle East and several other Asian countries. We specialize in the placement of candidates in permanent, contract, temporary and interim positions with clients around the world.