Invites for QA Engineer-HC in GE Healthcare

GE Healthcare, $17 billion unit of General Electric Company (NYSE: GE), employing more than 46,000 people worldwide and serving healthcare professionals in more than 100 countries. We believe in our strategy - and we'd like you to be a part of it. As a global leader, GE can bring together the best in science, technology, business and people to help solve one of the world's toughest challenges and shape a new age of healthcare.

Post: QA Engineer-HC

Job Description:
The QA Engineer will manage quality systems, processes, as well as support key QA areas and procedures to assure product safety and quality by driving business alignment to correct industry requirements and business Objectives.
Essential Responsibilities
Key responsibilities include:
• Accountable for assisting the Quality Assurance Site Manager to ensure/follow up/implement
Corrective actions that are raised by deviations, internal audit or regulatory inspection
• Responsible for managing quality systems, processes and procedures to assure product
quality and safety
• Leading Production Process & CAPA activities including coordination/management of overall CA/PA system, CAPA Impact Analyses, and Product Field Action Coordination and execution
• Ensuring regulatory compliance and optimization of quality system procedures relating to CAPA, complaint handling, adverse event reporting and product field actions through development, maintenance and improvement of documented processes, development and implementation of employee training, and development and implementation of quality metrics to drive improvement and business results
• Leading/Supporting key QA activities as assigned including Design controls, Internal Auditing
• Identify and report any quality or compliance concerns and take immediate corrective action as required

Quality Specific Goals:
1. Continue to develop a working knowledge of, and train others on, 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. Conduct mock audits to assess responsible functions and processes and identify areas for improvement/increased compliance.
3. Maintaining compliance to Quality System Regulation (QSR) and Current Good Manufacturing Practices (cGMP) requirements by supporting successful internal audits, assist in the reduction of significant audit findings from previous inspections and helping prevent repeat findings from previous GAC audits.
4. Develop, implement and maintain an effective GEHC QMS procedure with aligned internal procedures and associated training.
5. Perform investigations and action plan activities to ensure timely closure.
6. Provide direction and guidance to peers and subordinates to assist with their learning and effectiveness.

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Qualifications/Requirements
1. Bachelor's degree or Associate’s degree (or high school diploma/GED plus 4 years of related work experience).
2. Minimum of 3 years experience in a medical device or pharmaceutical industry.
3. Minimum of 3 years experience with Quality Systems Areas like Design Controls, CAPA systems, Production Process Controls.
4. Minimum of 3 years experience applying regulations (including FDA QSR, ISO13485).
5. Ability to communicate effectively (both written and oral) in English

Desired Characteristics
Preferred Qualifications:
1. Stress Tolerance: Accepting constructive criticism and dealing calmly and effectively with high-stress situations. This includes continuing to persevere and remaining calm in challenging circumstances.
2. Dependability: Being reliable, responsible, dedicated, committed and fulfilling obligations
3. Adaptable/Flexible: Being open to change (positive or negative) in response to new information, different or unexpected circumstances, and/or to work in ambiguous situations
4. Integrity: Accepting and adhering to high ethical, moral, and personal values in decisions, communications, actions, and when dealing with others
5. Ability to work independently in fast-paced environment with little supervision.
6. Ability to identify root cause of problem, and creatively problem solve to gain resolution.
7. Ability to adapt to constant change.
8. Team-oriented and responsive to customer needs.
9. Strong Problem Solving skills.
10. Quality-Focused, Attentive to Detail and Results-Oriented.
11. Ability to influence positive change effectively.
12. Prior experience using word processing, spreadsheet, and presentation software.
13. Auditor Certification.
14. Familiar with Continuous Improvement methodologies, including Six Sigma.
15. Experience with Training and course development.

Additional Information:
Experience: 3-4 years
Job ID: 1819580
Location: Bangalore
Industry Type: Pharma/ Biotech/Clinical Research
Functional Area: QA
End Date: 22^th Aug, 2013