Snr Quality Engineer / Quality Engineer

HERAEUS MEDICAL COMPONENTS SINGAPORE PTE. LTD.; Singapore, Serangoon Garden Circus; On-site; SGD 60,000 - 90,000; Full time

Job summary

A leading company in medical device components is seeking a Quality Engineer to enhance customer experience and ensure compliance with ISO 13485. This role is integral to overseeing quality systems, conducting audits, and leading investigations into nonconformities. The ideal candidate will have a strong background in engineering, quality assurance, and experience within the medical device sector.

Qualifications

• 5-7 years experience as a Senior Engineer or 2-3 years as an Engineer in a technical role.
• Experience in ISO 13485 and medical device fields preferred.

Responsibilities

• Lead processes for nonconforming material, including disposition and investigation.
• Develop and update work instructions for inspection techniques.
• Prepare quality documentation and reports, analyzing trends.

Skills

Process capabilities

Statistical analysis software

Root cause analysis

Six Sigma tools

Geometric Dimensioning and Tolerancing

Education

BA/BS in Engineering

BA/BS in Scientific Discipline

Job description

This position will be the lead HMCS Quality presence at the site.

They will be responsible for ensuring the desired customer experience by supporting the process development of manufactured products and ensuring conformance to customer specifications and requirements. This includes developing robust statistically based inspection methods, investigating, evaluating, and dispositioning nonconforming products.

The role involves ensuring the effective utilization of Quality systems (ISO 13485) and enforcing compliance with relevant regulations. This position reports to the Site Quality Manager/Leader.

Responsibilities

1. Work with internal/external customers providing inspection, testing, process capability support, qualifications/validations, GRR, Minitab analysis, FAI analysis, and inspection plans promptly.
2. Review and update work instructions related to inspection techniques and equipment, collaborating with Engineering to meet metrology needs.
3. Lead processes for nonconforming material and product, including disposition, investigation, CAPA/corrections, and customer communication.
4. Serve as Key User and lead in ERP (Quality) and EQMS systems.
5. Maintain and coordinate internal and external audits (ISO 13485).
6. Support quality methodologies for process changes and communicate these with the customer.
7. Provide training based on expertise or demonstrated work experience, utilizing training tracking systems and ensuring training requirements are current.
8. Prepare quality documentation and reports by analyzing and summarizing information and trends such as failed processes, stability studies, customer returns, corrective actions, and re-validations.
9. Enhance department and organization reputation by taking ownership of new and different requests and exploring opportunities to add value.
10. Perform other duties or projects as assigned by management and the Global Quality Team.

Education

• Senior Engineer - BA/BS in Engineering with 5-7 years of experience, or in a scientific discipline with 7-10 years in an engineering or technical role.
• Engineer - BA/BS in Engineering with 2-3 years of experience, or in a scientific discipline with 2-4 years in an engineering or technical role.

Experience

• Preferably experience in an ISO 13485:2003 and/or 9001:2000 work environment.
• Medical device experience is a plus.
• ASQ Certified Quality Engineer preferred.
• Ability to utilize MRP or ERP software and Statistical Analysis Software.
• Training in root cause analysis, project management, statistical analysis, SPC, Six Sigma tools, and Geometric Dimensioning and Tolerancing.