Quality Assurance & Control (Manufacturing, Transport & Logistics)
Full time
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Demonstrates commitment to the Quality Policy (patient safety and product quality) through their daily execution of sound quality practices and the maintenance of an effective quality system. Understandsand complieswith all the regulations governing the quality systems.Ensurestheir direct reports are aware of their commitment to patient safety and product quality, are current with their training requirements and that they understand and comply with all other regulations governing their work.
Key Responsibilities
Mentors Engineers on Problem Solving Tools
Selects appropriate techniques for problem solving and makes solid and consistent Engineering and Quality Assurance recommendations.
Drives Problem Solving Culture within own area Leads projects within own team or sepcialised projects at department level SME for Medical Device Related Standards and Regulations
Has the responsibility and independent authority to make decisions related to product quality, including the disposition of non-conforming product.
Identify Distribution supply chain including Inbound as well as outbound process defects (scrap, nonconforming material) by dispositioning non-conforming material, assisting in identification of primary root causes and understanding corrective and preventative actions.
Own and/ or provides support in the execution and investigation of CAPAs, NCEP, Failure Mode Investigations, etc.
Demonstrates and actively promotes highest levels of professional QA engineering discipline
Lead and drive Quality related initiatives/ project including enabling new capabilities
Reviews and approves CN to ensure compliance and adequacy of process establishment as well as change made to the process.
Champions continuous improvement and innovation from a quality perspective within the department right from vendor selection/approval through to customer awareness/satisfaction.
Is an effective team member, fully motivated to achieve and demonstrate best practices in line with the department and organization objectives.
Gives technical guidance to Quality Engineers, Quality Technician and other functional department key stakeholder.
Familiar with the Certification Body audit such as ISO 13485 / MDSAP/ GDPMD.
Job Requirements:
Candidate required process at least Bachelor Degree in any Engineering course, Mathematic, Statistic and Analytic or other Science related course.
At least 8 -10 years of working experience in Quality environment preferably in Quality System regulated organization - ISO 9001/ ISO 13485.
Experience in Distribution Quality / Operations Quality / Quality System will be with added advantage.
Skill: Excellent Influencing and communication skill, good team player, positive attitude to excel work toward success, problem solving skill and possess leadership dependencies to be able to lead team for issue investigation.
Project Lead in Cross Function and Area Level Projects
As lead to small Group of junior engineer
Your application will include the following questions: Which of the following types of qualifications do you have? Which of the following statements best describes your right to work in Malaysia? How many years' experience do you have in a quality assurance (QA) role? What's your expected monthly basic salary? How many years' experience do you have as a Quality Engineer? Do you have a Bachelor Degree?Manufacturing, Transport & Logistics1,001-5,000 employees
Boston Scientific transforms lives through innovative medical solutions that improve the health of patients around the world. As a global medical technology leader for more than 40 years, we advance science for life by providing a broad range of high performance solutions that address unmet patient needs and reduce the cost of healthcare.
Our work is guided by core values that define Boston Scientific culture and empower our employees.
Boston Scientific by the numbers:
45K employees worldwide
33M patients treated each year
16,000+ products that change lives
$12.682 billion sales in 2022
130 countries with commercial representation
- from Boston Scientific Performance Report 2022.
Expanding our footprint in APAC
In 2017, we opened our first manufacturing facility in Asia in Penang, producing medical devices including diagnostic and therapeutic technologies. In 2022, we expanded our presence in Malaysia Penang with a Global Distribution Center to manage the distribution of medical devices within Malaysia and around the world.
Boston Scientific transforms lives through innovative medical solutions that improve the health of patients around the world. As a global medical technology leader for more than 40 years, we advance science for life by providing a broad range of high performance solutions that address unmet patient needs and reduce the cost of healthcare.
Our work is guided by core values that define Boston Scientific culture and empower our employees.
Boston Scientific by the numbers:
45K employees worldwide
33M patients treated each year
16,000+ products that change lives
$12.682 billion sales in 2022
130 countries with commercial representation
- from Boston Scientific Performance Report 2022.
Expanding our footprint in APAC
In 2017, we opened our first manufacturing facility in Asia in Penang, producing medical devices including diagnostic and therapeutic technologies. In 2022, we expanded our presence in Malaysia Penang with a Global Distribution Center to manage the distribution of medical devices within Malaysia and around the world.
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