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 device company in Malaysia seeks an experienced Quality Engineer to oversee product quality, investigate customer complaints, and drive continuous improvement initiatives. Candidates should possess at least 9 years of quality operations experience, preferably in the medical device industry, and a degree in engineering. Strong problem-solving and data analysis skills are essential. This role offers competitive compensation and opportunities for professional growth.

Qualifications

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

Responsibilities

• Make engineering and quality assurance recommendations.
• Identify manufacturing process defects.
• Lead customer complaints investigations.
• Document investigation findings.
• Provide technical guidance to team members.

Skills

Problem-solving tools

Data analysis

Quality operations fundamentals

Cross-functional management

Education

Minimum Degree in Engineering

Job description

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 promoting awareness of best industry practices and making appropriate decisions on a daily basis using the Quality Engineering Manager/Site QA Director as the final arbitrator on critical quality decisions.
• Has significant expertise in validation engineering and is thoroughly familiar with all regulatory requirements.
• 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 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, technicians 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.

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Your application will include the following questions:

• 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?