Quality Engineer

2 days ago

Singapore QUASAR MEDICAL (SINGAPORE) PTE. LTD. Full time

**JOB SUMMARY**:
The Quality Engineer is responsible for the product quality activities within Quasar Medical Singapore Operations. This will include support for new product development and transfers.

**ESSENTIAL DUTIES AND RESPONSIBILITIES**:
Include the following. Other duties may be assigned.
- Maintain and comply with the requirements of ISO13485, GMP, FDA 21 CFR Part 820 and other applicable regulations.
- Participate in the internal and notified body audit programs as required.
- Management of MRR activities.
- Ensure that required specifications are implemented for incoming/ in-process/ outgoing quality inspections,
- Ensure that non-conforming products are properly handled via Non-Conforming Materials Review (NCMR) process.
- Establishing inspection standards, plans, frequencies and test methods.
- Lead and drive QA initiatives across the product areas.
- Support and drive cost improvement project
- Investigating root cause of quality issues and following through with timely and effective corrective actions to prevent re-occurrence.
- Drives robust and effective corrective and preventive action programs through the CAPA system.
- Strategically lead new product introduction from a QA perspective.
- Overall responsibility for production GMP standards and compliance, also including cleanroom requirements.
- Participate in new product introductions to ensure quality is built into all products early in their life cycle
- Support Production on all quality-related activities, including working closely with Engineering and other applicable functions.
- Assist in the investigation and analysis of customer complaints and follow-up with the relevant functions to ensure that they are addressed & closed in a timely manner.
- Assist in the definition of qualification/validation processes and the development of protocols in conjunction with appropriate functions.
- Supervision and direction of other Quality personnel.
- To support audits from customers and external regulatory agencies (FDA, BSI etc)
- Participates in Customer Complaints investigation for areas under their control and escalates critical issues as appropriate.

**EDUCATION/ EXPERIENCE AND QUALIFICATIONS**:

- Degree in Engineering or equivalent, with 3 - 5 yrs of progressive Quality responsibility, preferably in medical device manufacturing. Diploma holders in Engineering or equivalent with >5 years' relevant experience may be considered
- Excellent communication & project management skills.
- Demonstrated proficiency in use of engineering tools 6SlGMA, FMEA, DOE, SPC, etc.
- Knowledgeable in writing manufacturing procedures to QMS/GMP requirements.
- Knowledge of ISO13485, FDA 21 CFR Part 820, and/or the Medical Device Directives.
- Proven abilities in decision making and sound personal judgement. Good organization, supervisory and investigation skills are required.
- Proven ability to influence.

**WORK ENVIRONMENT**:
While performing the duties of this Job, the employee is frequently exposed to moving mechanical parts. The noise level in the work environment is usually moderate.

Controlled Environment (Class 10K/100K cleanroom) and office area.

  • Project Engineer

    10 hours ago

    Singapore QUALITY TECHNOLOGY PTE. LTD. Full time

    **Salary Range: $3500~$4500 **JOB TITLE: PROJECT ENGINEER / CO-ORDINATOR **RESPONSIBILITIES**: - Co-ordinate with Other Project Engineers/Clients & Site Supervisors at projects’ sites, on progress of schedule and work done - Supervise and Inspect jobs done (Quality & Quantity) at projects’ sites. - Base on Site Supervisors’ requisition, Send materials...

  • Quality Engineer

    4 weeks ago

    Singapore OTSAW DIGITAL PTE. LTD. Full time

    Roles & ResponsibilitiesJob Summary:The quality engineer will have a strong background in quality assurance and control within the robotics industry, with a focus on assembly processes. This role will be responsible for ensuring the highest standards of quality are maintained throughout all products' lifecycles.Key Responsibilities:· Develop, implement, and...

  • Quality Engineer

    2 days ago

    Singapore Gas Power Global Supply Chain Full time

    **Job Description Summary**: The Quality Engineer supports the manufacturing cell in aspects of quality assurance/ control and is responsible for the quality planning and conformance of Product/Process Quality to Customer and Engineering requirements. This role reports directly to the Quality Manager. Essential Responsibilities: Key responsibilities include...

  • Quality Engineer

    1 week ago

    Singapore GRAND ADVANCE TECHNOLOGIES PTE LTD Full time

    **Job description** A reliable Engineer of Quality Assurance to ensure that all external and internal requirements are met before our product reaches our customers. She will be responsible for inspecting procedures, outputs and identifying mistakes or non-conformity issues. An excellent Engineer with industry proficiency in 2D/ 3D dimensional inspection,...

  • Quality Engineer

    10 hours ago

    Singapore Celestica Full time

    Quality Engineer Req ID: 95241 Region: Asia Country: Singapore State/Province: Alexandra Road **Summary**: We are looking for a Quality Engineer to monitor and improve the quality of our operational processes and outputs. The Quality Engineer's responsibilities include designing quality standards, inspecting materials, equipment, processes, and products,...

  • Quality Engineer

    1 week ago

    Singapore SHARE RESOURCES PRIVATE LIMITED Full time

    **Quality Engineer** **Responsibilities**: - Lead for the QE planning and management of resources in support of PCS, Global product qualification and certification process in the Innovation Process and Life Cycle Management (LCM). - Lead and support the implementation in Asia region for the PCS - Regulatory Services, Standardisation, Material compliance...

  • Quality Engineer

    7 days ago

    Singapore OIP TECHNOLOGY PTE. LTD. Full time

    **Responsibilities: - Develop and implement quality control procedures and guidelines for semiconductor manufacturing processes. - Collaborate with engineering, production, and quality assurance teams to identify potential quality issues and develop effective solutions. - Liaise with audit, Customer, ISO certification, and Regulatory departments. - Perform...

  • Quality Engineer

    2 weeks ago

    Singapore PERSOLKELLY Full time

    Based in Singapore Permanent role Mandarin speaking **Job Description**: - Develop, implement, and improve the department and product total quality system to assure product specification is met - Perform system or process audit to assure quality systems are in place - Develop, implement, and improve product quality plan - Provide quality engineering...

  • Quality Engineer

    10 hours ago

    Singapore TEMPSERV PTE. LTD. Full time

    **Responsibilities**: - Manage customer complaints, corrective and preventive action programs. - Work closely with customers, production and suppliers to meet the quality requirements. - Review / prepare, administer and implement Quality Assurance Plans, Inspection Test Plans and other Operational procedures in accordance to the technical specifications,...

  • Quality Engineer

    2 weeks ago

    Singapore PEGATRON SERVICE SINGAPORE PTE. LTD. Full time

    **Job Purpose**: Assist the development of the SQE department by contributing to the daily QA operation and maintaining the high level of efficiency for all new models and engineering changes. Provide strong impetus to support continuous improvement in view of meeting all relevant KPIs for the company. Provide a framework with clear structure to build on the...