Quality Assurance & Control (Manufacturing, Transport & Logistics)
Full time
Main Responsibilities:
Take responsibility for Quality Assurance for GN Resound JB.
Contribute to strategic planning and decision making at the top executive level to align with the vision, mission, and long-term objectives of the corporate organization.
Develop and implement a quality system together with quality control programs to achieve high product quality and an effective quality system.
Assume the responsibility for quality system management representative and the responsible engineering manager.
Establish general quality strategy of the company and determine the quality policy and objectives.
Establish, implement, and improve the quality management system, setting quality standards and related documentation, and controlling implementation.
Oversee the operation of the QA team to ensure product quality meets requirements of medical device regulations, company policy, and customer/procedure requirements.
Establish and optimize inspection standards of incoming, process control, and finished goods, and monitor performance.
Drive improvements through customer complaints.
Approve department-related quality system documents and the closure of quality system nonconformities.
Approve closure of CAPA related to product quality.
Continuously contribute, develop, and implement ideas that improve performance.
Proactively join in supplier quality performance management, collaborating with engineering and procurement departments to assess suppliers.
Handle internal and external customer complaints, communicating with customers and quality control on quality-related issues.
Conduct internal quality audits, initiating and participating in management reviews.
Provide essential and basic skill training for the quality department and enhance the quality concept among employees.
Follow customer/external audits.
Professionalize all quality systems and personnel, moving from inspecting quality to designing and ensuring process quality.
Develop and implement document control programs, interface with global customers, and design and implement vendor programs for quality systems.
Provide customers worldwide with quality service to support sales and marketing.
Maintain and develop quality systems.
Ensure implementation and adherence to Health, Safety & Environmental (HSE) procedures in areas of responsibility.
Perform any other tasks assigned by the superior.
Requirements/Skills:
Strong understanding of production procedures and quality control.
Leadership skills and strong business acumen.
Familiarity with electronic production procedures.
Strong data analytical and problem-solving skills.
Fluent in both oral and written English; proficient in computer skills.
Knowledge of FDA QSR Part 820 (Class 1 and Class II Medical Devices).
Experience with Medical Device Single Audit Program (MDSAP).
Knowledge of ISO13485 (current version).
Familiarity with Medical Device Act 2012 (Act 737).
Other Requirements:
High level of responsibility.
Good team player.
Positive personality.
Good summarization and presentation skills.
Systematic and global mindset.
Qualification and Experience:
More than 10 years of related management experience.
Diploma/Bachelor's degree or higher, majoring in Engineering or Science.#J-18808-Ljbffr