Senior Quality Engineer

Boston Scientific Medical Device (Malaysia) Sdn. Bhd.; Penang; On-site; MYR 150,000 - 200,000; Full time

Job summary

A leading medical technology firm in Malaysia is seeking a Senior Supplier Quality Engineer to ensure compliance with quality regulations and maintain an effective quality system. The ideal candidate will have at least 9 years of experience in Operations Quality, preferably in the medical device industry, and will be responsible for leading quality assurance initiatives and continuous improvements. This role is critical in supporting product quality and safety and requires strong problem-solving and data analysis skills.

Qualifications

• At least 9 years of working experience in Operations Quality, preferably in the medical device industry.
• Strong understanding of quality operations fundamentals, including product risk assessment.
• Experience in product transfer is an added advantage.

Responsibilities

• Ensure compliance with quality regulations and maintain an effective quality system.
• Participate in customer complaints investigation for controlled areas.
• Champion continuous improvement and innovate from a quality perspective.

Skills

Problem-solving

Quality Assurance

Data analysis

Cross-functional management

Education

Degree in Engineering

Job description

Senior Supplier Quality Engineer - Optics

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. Understands and complies with all the regulations governing the quality systems. Ensures their 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.

Job Description

Selects appropriate techniques for problem solving and makes solid and consistent Engineering and Quality Assurance recommendations.

Read and interpret technical drawings, procedures, and protocols.

Has the responsibility and independent authority to make decisions related to product quality, including the disposition of non-conforming product.

Identify Manufacturing process defects (scrap, nonconforming material, customer complaints) by dispositioning non-conforming material, assisting in identification of primary root causes and understanding corrective and preventative actions. May be responsible for working with process owner to bound product stops and document release criteria.

Participates in Customer Complaints investigation for areas under their control.

Document investigation findings in analysis report on GCS2.

Become a trainer for the Software related with complaints handling process (GCS2), as required.

Checks and 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 and rigor.

Is viewed as a leader in the areas of QSR and ISO/MDD standards within one's own group, constantly promotion awareness of best industry practices making appropriate decisions on a daily basis using the Quality Engineering Manager/Site QA Director as the final arbitrator on critical quality decision.

Has significant expertise in validation engineering and is thoroughly familiar with all regulatory requirements.

Checks and provides support in the execution and investigation of CAPAs, NCEP, Failure Mode Investigations, etc.

Reviews and approves operational, test and validation data to establish technical specifications and performance standards for newly designed or modified products and processes.

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 LRP objectives.

Gives technical guidance to Quality Engineers, Associate Quality Engineers, technician and inspection staff.

Works with EHS to identify significant environmental impacts of Boston Scientific operations and to establish goals and targets around significant environmental impacts.

Deals with suppliers, other engineering disciplines within and outside of Site and customers should the need arise.

Is familiar with the internal auditing process.

Job Requirements

Minimum Degree in Engineering field.

At least 9 years of working experience in Operations Quality. Prior experience in the medical device industry is preferred.

Resolves issues using standard problem-solving tools and a strong understanding of quality operations fundamentals, including product risk assessment and data analysis to identify root causes and drive solutions. Communicates findings clearly and effectively. cross-functional management.

Experience in product transfer will be added advantage.

Unlock job insights

Salary match Number of applicants Skills match

Your application will include the following questions

• Which of the following types of qualifications do you have?
• How many years' experience do you have as a Quality Engineer?
• How many years of auditing experience do you have?
• Which of the following statements best describes your right to work in Malaysia?
• What's your expected monthly basic salary?
• How many years' experience do you have in a quality assurance (QA) role?
• How much notice are you required to give your current employer?
• Do you have a Bachelor Degree?

Manufacturing, Transport & Logistics 1,001-5,000 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.