Lead Specialist, Product Surveillance, Ultrasound

Summary

Uses quality knowledge combined with skills in Product Surveillance to handle complaints, support regulatory reporting, and establish appropriate corrective and preventive actions for the safe and effective use of GE HealthCare Ultrasound products.

This position is located at the Wuxi Office.

GE HealthCare is a leading global medical technology and digital solutions innovator. Our purpose is to create a world where healthcare has no limits. Unlock your ambition, turn ideas into world-changing realities, and join an organization where every voice makes a difference, and every difference builds a healthier world.

• Evaluate complaints from patient safety perspective and identify complaints that require further evaluation according to global regulations, including 21CFR part , 803 (MDR), MDD/MDR, ISO 13485, etc.
• Manage risk by identifying product safety issues; triage complaints for further investigation.
• Responsible for hazard evaluations.
• Perform complaint closure according to set criteria and monitor through quality metrics.
• Applies engineering/quality experience and standards in post market product surveillance activities.
• Ensures on time submissions of safety and regulatory reports to regulators.
• Provides objective evidence of complaint handling process through compliant documentation.
• Ensure zero repeat findings from previous internal and external audits within area of responsibility.
• Analyze data on patient safety and risk, ensuring compliance with applicable post market regulations.
• Participates in increased skilled tasks such as complaint trending, in-depth data analysis, risk assessments, approval of complaint investigations (CAPA), and communications with upper-level leaders, and/or leading projects.
• Ensure timely complaint trending analysis and complaint investigations.
• Support business during internal and external audits of GE Healthcares Quality Management System (QMS).
• Communicate post market metrics to business and site leaders.
• Develops in-depth knowledge of GE HealthCares Quality Management System and Product Surveillance activities, including complaint trending and CAPA. Uses prior experience and acquired expertise to execute timely complaint handling process.
• In-depth understanding of key business drivers and applies this understanding to accomplish Product Surveillance activities. In-depth understanding of how work of Product Surveillance integrates with other teams and contributes to other areas of the business.
• Utilizes technical expertise and judgement to solve problems.
• Resolves issues in situations that require good knowledge and judgment within established procedures.
• Uses multiple internal sources outside of own team to arrive at decisions.
• May need to request technical or clinical information from engineering, field service, clinical applications personnel, or end user/customer to solve issues.
• A job at this level requires proven interpersonal skills. Communicates directly with colleagues and the Ultrasound business about post market activities. Communicates effectively with upper-level leaders. Explains technical information to others, including informal guidance to new team members. Explains complex information to others in straightforward situations.
• Handles simple data entry work requiring face value check and correction.
• Impacts projects, processes, and procedures within post market, often leading such projects. Identifies areas of improvement and promotes execution of standardized activities through participating in team, internal, and external audits. Activities require professional judgement but may require more senior levels of guidance. Manages time to complete task/duties based on changing situations.
• Accountable for quality of own work, and for meeting or exceeding teams quality metrics.
• Aware of and comply with the GE HealthCare Quality Manual, Quality Management System, Quality Management Policy, Quality Goals, and applicable laws and regulations as they apply to this 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.

• Bachelor's degree or equivalent from an accredited university or college; OR high school diploma/GED and a minimum of 6 years work experience in complaint handling, quality, or regulatory function.
• A minimum of 4 years work experience in medical device or pharmaceutical industry in an Engineering, Quality, or Regulatory related role.
• Ability to communicate clearly in both English and Chinese, verbally and in writing.

• Medical device industry preferred.
• Demonstrated knowledge of ISO 13485, 21CFR part 820, 803, 806, MDD/MDR.
• Ability to work independently & in a team setting.
• Demonstrated experience prioritizing conflicting demands in an extremely fast paced environment.
• Excellent verbal, written, and presentation skills.
• Excellent interpersonal, organizational, and influencing skills.
• Familiarity with the application of medical device as it relates to patient safety.
• 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.
• Prior experience working with Microsoft Office products.
• Advanced Excel skills, may include Macros.
• Prior experience conducting root cause investigations and implementation of CAPA.
• Understanding of data analytic concepts, including trending processes and analysis.
• GE HealthCare Product-specific knowledge Ultrasound.
• Ability to demonstrate GE HealthCare Operating Principles.

GE HealthCare is an Equal Opportunity Employer where inclusion matters. Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status or other characteristics protected by law.

We expect all employees to live and breathe our behaviors: to act with humility and build trust; lead with transparency; deliver with focus, and drive ownership always with unyielding integrity.

Our total rewards are designed to unlock your ambition by giving you the boost and flexibility you need to turn your ideas into world-changing realities. Our salary and benefits are everything youd expect from an organization with global strength and scale, and youll be surrounded by career opportunities in a culture that fosters care, collaboration and support.

Wuxi, Jiangsu, China, 214028