GE is an equal opportunity employer, offering a great work environment, challenging career opportunities, professional training and competitive compensation.
The Complaints Manager leads compliant global business processes related to post-market product surveillance, and supports efforts for regulatory reporting and establishing appropriate corrective & preventive actions for the safe and effective use of GE Healthcare (GEHC) products.
• Lead a team of Product Surveillance professionals in meeting global regulations in the areas of post-market complaint handling, adverse event management, global reporting, trending, and CAPA
• Develop and drive improvements to overall Quality Management System documentation to provide clear flow down of regulations in related post-market areas
• Train, advise and coach business leaders and QA/RA practitioners on the related regulations, procedures and work instructions
• Audit business units for compliance and consistency, and track/address trends observed that could lead to non-compliance or risk to patient/user safety
• Interface with senior leaders and site leader partners during inspections, audits, investigations, and report-outs as necessary
• Lead cross-team process improvements, resulting in simple, sustainable and compliant processes
Quality Specific Goals:
1. Meet all global reporting and product surveillance activities in accordance with global regulations and all GEHC procedures and instructions.
2. 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
3. Complete all planned Quality & Compliance training within the defined deadlines
4. Identify and report any quality or compliance concerns and take immediate corrective action as required
5. Maintaining full Quality System Regulation (QSR) and Current Good Manufacturing Practices (CGMP) requirements
1. Bachelor’s degree in scientific, technology, engineering or clinical discipline and minimum 3 years working experience in a Quality Assurance or Regulatory Assurance (QARA) role within the medical device or bio-pharmaceutical industry
2. Demonstrated ability to lead cross-functional teams and facilitate those teams to identify and implement solutions to complex problems
3. Demonstrated knowledge of Quality Management Systems and the requirements of key regulatory bodies (ISO, FDA etc)
4. Demonstrated knowledge and ability to combine clinical expertise, product use and regulatory knowledge to make clear post market product decisions.
Additional Eligibility Qualifications
GE will only employ those who are legally authorized to work in the United States for this opening. Any offer of employment is conditioned upon the successful completion of a background investigation and drug screen.
1. Master’s degree in scientific, technology or clinical discipline
2. ASQ Certification as Quality Manager (CQM), Operations Excellence (OE), or other related discipline
3. Previous experience leading/managing/supervising teams
4. Subject matter expert in post-market surveillance and complaint handling, regulatory reporting, post-market CAPA, and/or field corrections for medical devices
5. Ability to prioritize, plan & evaluate deliverables to established strategic goals; demonstrated experience prioritizing conflicting demands in an extremely fast paced environment
6. Demonstrated process/lean skill to drive project execution with discipline
7. Demonstrated ability to provide feedback & coaching to help develop others
8. Ability to build trust while engaging the team in constructive dialogue to drive improvements in organization capacity and productivity
9. Product-specific knowledge
10. Ability to demonstrate GEHC Growth Values
11. Demonstrated experience prioritizing conflicting demands in an extremely fast paced environment
12. 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).
13. Excellent interpersonal, organizational, and influencing skills
14. Working knowledge of GEHC products
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