Associate Specialist, Product Surveillance, ARC

Job Description Summary

Manages complaint handling activities and supports key Quality & Regulatory areas to ensure safe and effective products in the install base across GE Healthcare Developing conceptual knowledge of professional discipline. May include support roles with specialized expertise or technical knowledge in broad area.This is a hybrid role that requires being on-site in Madison, WI two days per week.GE HealthCare is a leading global medical technology and digital solutions innovator. Our mission is to improve lives in the moments that matter. 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.

Job Description

Roles and 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.

• Identify and report any compliance gaps related to the full Quality System Regulation (QSR) and Current Good Manufacturing Practices (CGMP) requirements.

• Ensure zero repeat findings from previous internal and external audits within area of responsibility.

• Timely complaint handling and reporting.

• Provide objective evidence of complaint handling process through compliant documentation.

Required Qualifications:

• Bachelor's degree from an accredited university or college (or a high school diploma / GED with at least 2 years of experience in Quality or Regulatory Assurance / Engineering).

• Experience in the medical device industry.

Desired Characteristics:

• Product specific knowledge in Anesthesia machine and ICU Ventilator devices.

• Demonstrated knowledge of Quality Management System tools, continuous improvement methodologies & in-depth understanding of site level products & related processes.

• Demonstrated expertise to effectively communicate within all levels of the organization around concepts of design controls, design verification and validation activities; production &process controls; Corrective & Preventive Action (CAPA), complaints & risk management; & product quality improvement using tools such as six sigma, DFR, etc.

• Demonstrated knowledge of 21CFR Part 820.

• Demonstrated experience prioritizing conflicting demands in an extremely fast paced environment.

• 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.

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 you’d expect from an organization with global strength and scale, and you’ll be surrounded by career opportunities in a culture that fosters care, collaboration, and support.

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We will not sponsor individuals for employment visas, now or in the future, for this job opening.

Additional Information

While GE HealthCare does not currently require U.S. employees to be vaccinated against COVID-19, some GE HealthCare customers have vaccination mandates that may apply to certain GE HealthCare employees.