南京招聘

Business Segment

Healthcare Quality

Role Summary/Purpose

The QA Leader will manage quality systems, processes, and procedures to assure product safety and quality by driving business alignment to correct industry requirements and business objectives by managing quality system design, controls, and continuous improvement.

Essential Responsibilities

• 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
• Responsible for engaging strong intradepartmental and cross-functional/organizational relationships to drive Quality System Requirements (QSRs)
• Owning the development and maintenance of policies and procedures for departmental functions
• Providing leadership and facilitates problem resolution, resource utilization, career counseling, coaching and mentoring of team members
• Influencing site compliance to Quality policy, Quality Management System procedures, and Quality Star guidelines
• Influencing participation in compliance to internal and external regulations
• Influencing quality system metrics such as Corrective and Preventive Action, training metrics, completion and complaint resolution metrics

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. Zero repeat findings from previous internal and external audits
5. Assure site and business is properly prepared for external and internal compliance inspections by the results of the inspections finding no systemic or warning letter findings.
6. 100% implementation of all quality system procedures, work instructions and requirements
7. Assure specific site goals are established and met for compliance, training, CAPA, complaints and production process controls.

Qualifications/Requirements

Qualifications:
1. Bachelor’s degree (or high school diploma/GED plus 4 years experience work experience)
2. 3 years experience working in a regulated medical device or pharmaceutical environment, quality control/assurance, or regulatory assurance
3. 1 year experience managing people (if QA Leader will have direct reports)
4. Ability to effectively communicate using English (or local language)

Preferred Qualifications:
1. Demonstrated experience in the medical device or pharmaceutical industry and knowledge of quality system regulations and policies
2. Demonstrated ability to develop & lead process implementation & improvement in a team environment
3. Experience with some or all of the following:
 Design controls, design verification and validation activities
 Production and process controls
 CAPA, complaints and risk management
 Understanding of product quality improvement using tools such as Six Sigma, DFR
 Experience performing internal audits
4. Demonstrated effective interpersonal and networking skills
5. Prior experience using word processing, spreadsheet, and presentation software
6. Demonstrated ability to successfully comprehend & carry out/execute actions
7. Effective oral and written communication skills
8. Analytical & problem-solving skills/root-cause analysis
9. Exceptional conflict-resolution skills
10. Ability to interface with top organizational leadership and internal and external customers, responding in a professional manner
11. Ability to prioritize and drive multiple programs
12. Integrity: Accepting and adhering to high ethical, moral, and personal values in decisions, communications, actions, and when dealing with others
13. Accepting constructive criticism and dealing calmly and effectively with high-stress situations. This includes continuing to persevere and remaining calm in challenging or frustrating circumstances
14. External Focus: Understanding customer needs, marketplace dynamics, industry trends, and the competitive landscape in the industry/function and considering the external impact of business activities and decisions on the external environment
15. Inclusiveness: Energizing others by building a connection with the team through personal involvement and trust and providing feedback and coaching to help develop others
16. Clear thinker: Simplifying strategy into specific actions with clear accountability, making decisions with speed and accuracy based on best available information, and communicating priorities clearly and concisely

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