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Lead - Product Surveillance

  • GE Healthcare
  • Experienced
  • Posted 5/8/2017 3:47:58 PM
  • 2864323
  • Job Function: Quality
  • Business Segment: Healthcare Quality
Location(s): India; Bangalore


About Us:
GE is the world's Digital Industrial Company, transforming industry with software-defined machines and solutions that are connected, responsive and predictive. Through our people, leadership development, services, technology and scale, GE delivers better outcomes for global customers by speaking the language of industry.

Role Summary:
This role combines skills in leadership, post market regulation, and product knowledge to lead a team of analysts in the complaint handling process.

Essential Responsibilities:
1. Leading a team of analysts as part of a complaint handling unit
2. Owning methods and procedures for effective trending of complaints
3. Ensuring timely complaint investigation
4. Engaging product design owners to determine effective CAPA
5. Ensuring timely handling of complaints that represent further evaluation under 21CFR Part 803 (MDR)
6. Reviewing and approving appropriate criteria for closure of complaints
7. Developing training plans, conducting training, and maintaining training records for team
8. Owning and communicating metrics on status during Quality Management Reviews
9. Continuously working to improve the process

Qualifications/Requirements:
Quality Specific Goals:
1. 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
2. Complete all planned Quality & Compliance training within the defined deadlines
3. Identify and report any quality or compliance concerns and take immediate corrective action as required
4. Identify and report any compliance gaps related to the full Quality System Regulation (QSR) and Current Good Manufacturing Practices (CGMP) requirements
5. Ensure zero repeat findings from previous internal and external audits within area of responsibility
6. Timely complaint handling and reporting
7. Provide objective evidence of complaint handling process through compliant documentation

Qualifications:
1. Bachelors degree in engineering or health sciences field; or a High School diploma/GED and minimum 4 years work experience in a Quality or Regulatory Assurance related field
2. Minimum 3 years’ experience in medical device or pharmaceutical industry in an Engineering, Quality or Regulatory related role


Quality Specific Goals:
1. 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.

2. Complete all planned Quality & Compliance training within the defined deadlines.

3. Identify and report any quality or compliance concerns and take immediate corrective action as required

Desired Characteristics:
1. Product-specific knowledge
2. Advanced degree in Quality Assurance and/or Regulatory Affairs field
3. Minimum 3 years experience with 21CFR Part 803
4. Ability to demonstrate GEHC Growth Values
5. Ability to quickly assess situations and make decisions
6. Demonstrated program management or leadership skills
7. Demonstrated experience prioritizing conflicting demands in an extremely fast paced environment
8. Ability to work independently and in a team setting
9. 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).
10. Excellent interpersonal, organizational, and influencing skills
11. Familiarity with the application of medical device as it relates to patient safety
12. Ability to analyze and process data, and draw the appropriate conclusions
13. Experience working with cross-functional teams and facilitating teams to identify and implement solutions to complex problems
14. Ability to analyze and process data, and draw the appropriate conclusions
15. Prior experience working with Microsoft Office products
16. Working knowledge of GEHC products

Locations: India; Bangalore
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