Senior Quality Engineer

2 weeks ago

Singapore Biotronik Apm Ii Pte. Ltd. Full time

PURPOSE OF THE POSITION

The Senior Engineer, Quality Operation CRM is responsible for all aspects of quality operations related to product safety and product quality assurance. He/She shall provide leadership and expertise on the application and interpretation of the site/Business procedures to ensure consistency and compliance with Quality Systems. Taking the lead to analyze quality data and drives root cause investigation, data analysis, deploying the appropriate statistical and data analytical tools.

ESSENTIAL JOB FUNCTIONS

  • Ensure that operational processes compliance against the established procedures, work instructions, drawings and/or specifications.
  • Evaluate discrepancies or non-conforming product/material in a timely manner for disposition. Lead investigation, working with process owners and/or subject matter experts to align on disposition/release criteria.
  • Champion investigation process and coordinate root-cause analysis (RCA tools) on non-conformities, risk assessment and initiate corrective/preventive actions that fulfills acceptable reliability/quality standards, and documentation that is compliant with requirements.
  • Provide review/approval to methods and procedures for evaluate, measure, control, monitor product or processes to meet the product quality characteristics/requirements of the products/processes. Coordinates and evaluate of analytical tests data, through applying statistical tools and techniques.
  • Provide technical QA review/ approval to product/processes change request submitted by engineering teams. Ensure change request/orders are technically well-written, risk assessed, strong justification and aligned on quality specification requirements.
  • Plan, risk assessment, test and qualify quality-related software changes and updates.
  • Provide guidance, coaching and support to other Quality engineer on improvement initiatives and quality activities as needed.
  • Provide quality reporting to stakeholders (for Quality figures, NC/defect trending, analysis and investigation results). Evaluate and analyze quality trends with the manufacturing team, to align on risk impact assessment and recommend actions for deficiency improvement.
  • Creation of Inspection plan in SAP and leading the coordination and investigation of deviations with incoming materials.
  • Partnering with Quality engineers and technicians to address quality operations related activities, including testing at In-coming, In-processes and out-going to ensure that products comply with quality standards, per BIOTRONIK specifications.
  • Quality Operations representative in supporting product transfer activities, partnering with engineering and operation teams in developing product transfer qualification, specification alignment and process validation plans for the transfers.
  • Support, execute projects and any others quality related activities as directed by supervisor.

BASIC QUALIFICATIONS

Education:

  • Technical / scientific degree at college / university level (mechanical, biomedical, polymer engineer-ing, natural sciences)

Experience:

Occupational experience

  • At least 10 years' work experience in a quality function in regulated environment (medical devices industry)
  • Expert knowledge on Quality Inspections techniques, Quality Tools, failure mode analysis and highly experience in handling measuring instruments.
  • Comprehending Technical Drawings.
  • Experience in Cleaning and Hygiene Regulations.
  • Knowledge in process validation and computer system validation.
  • Continuous Improvement (CI) Project experience.
  • Project management/ transfer experience will be an advantage.

Special knowledge, expertise, experience

  • cGxP Know-How incl. regulations ISO 13485, FDA 21 CFR 820, MDD 93/42/EEC
  • Preferred ISO 13485 Internal auditor / knowledge in FDA will be an advantage
  • Statistical methods
  • SAP (Manufacturing Execution Systems / MES will be an advantage)

  • Senior Quality Engineer, PQE

    2 weeks ago

    Singapore GMP Technologies Full time

    GMP is partnering with a well-known medical organization to hire a Senior Quality Engineer for their manufacturing operations in Singapore.Job ResponsibilitiesYou will be required to provide Quality Engineering support for Manufacturing Operations and resolving quality issues with process engineers with the company's standard operation procedure.There will...

  • Senior Quality Assurance Engineer

    1 week ago

    Singapore Firerock Capital Pte. Ltd. Full time

    Senior QA Engineer - Mobile Game CompanyLocation: SingaporePosition Overview:We are seeking a highly skilled and experienced Senior QA Engineer with a strong background in Automation Testing to join our dynamic team. The Senior QA Engineer will play a pivotal role in ensuring the quality and performance of our mobile games by developing and implementing...

  • Senior Quality Assurance Engineer

    Found in: Talent SG 2A C2 - 3 days ago

    Singapore FIREROCK CAPITAL PTE. LTD. Full time

    Roles & ResponsibilitiesSenior QA Engineer – Mobile Game CompanyLocation: SingaporePosition Overview:We are seeking a highly skilled and experienced Senior QA Engineer with a strong background in Automation Testing to join our dynamic team. The Senior QA Engineer will play a pivotal role in ensuring the quality and performance of our mobile games by...

  • Quality Assurance

    2 weeks ago

    Singapore Ovivo Singapore Pte. Ltd. Full time

    Job Description & Requirements. Lead inspection teams (IQA & OQA), QA/QC Supervisor to undertake tasks assigned. Manage Quality-related activities on the Project to ensure compliance to Project and applicable Regulatory requirement.. Work with Project stakeholders to provide a consistent Quality framework for application across all project deliverables and...

  • Quality Assurance

    Found in: Talent SG 2A C2 - 9 hours ago

    Singapore OVIVO SINGAPORE PTE. LTD. Full time

    Roles & ResponsibilitiesJob Description & Requirements· Lead inspection teams (IQA & OQA), QA/QC Supervisor to undertake tasks assigned· Manage Quality-related activities on the Project to ensure compliance to Project and applicable Regulatory requirement.· Work with Project stakeholders to provide a consistent Quality framework for application across all...

  • Quality Assurance

    Found in: beBee S SG - 2 weeks ago

    Singapore GREENSAFE INTERNATIONAL PTE LTD Full time

    Roles & ResponsibilitiesResponsible for assuring the implementation and compliance with the Quality Assurance System.Control and monitor all activities related to Quality Management System (QMS).Taking care of QA/QC documents of the entire project including certificates, calibration, test results, inspection requests, non-compliance reports and site...

  • Quality Assurance

    2 weeks ago

    Singapore Greensafe International Pte. Ltd. Full time

    Responsible for assuring the implementation and compliance with the Quality Assurance System.Control and monitor all activities related to Quality Management System (QMS).Taking care of QA/QC documents of the entire project including certificates, calibration, test results, inspection requests, non-compliance reports and site instruction/observations,...

  • Quality Assurance

    2 weeks ago

    Singapore Tnb Builder Pte. Ltd. Full time

    Responsibilities:. Responsible for assuring the implementation and compliance with the Quality Assurance System.. Control and monitor all activities related to Quality Management System (QMS).. Taking care of QA/QC documents of the entire project including certificates, calibration, test results, inspection requests, non-compliance reports and site...

  • Senior Process Quality Control Engineer

    1 week ago

    Singapore Silicon Box Pte. Ltd. Full time

    Position SummarySenior PQC Engineer (incoming / outgoing inspection) is responsible to develop & deploy inspection procedures to ensure conformance of material to be released.Candidates with experience in semiconductor manufacturing environment are encouraged to apply for this position.Key Responsibilities:Develop, plan & coordinate incoming/outgoing process...

  • Quality Assurance

    Found in: Talent SG 2A C2 - 3 days ago

    Singapore HUA SIAH CONSTRUCTION PTE LTD Full time

    Roles & ResponsibilitiesResponsibilities:· Responsible for assuring the implementation and compliance with the Quality Assurance System.· Control and monitor all activities related to Quality Management System (QMS).· Taking care of QA/QC documents of the entire project including certificates, calibration, test results, inspection requests, non-compliance...

  • Senior Manager, Quality Assurance

    Found in: beBee S SG - 4 weeks ago

    Singapore KBR Full time

    Title:Senior Manager, Quality AssuranceResponsibilities:Provide specialized technical knowledge of quality systems and tools and management expertise in support of project Quality programsEstablish and implement QA/QC in the engineering design environment and in support of procurement activitiesDevelop, maintain and improve quality procedures to meet project...

  • Senior Process Quality Control Engineer

    Found in: Talent SG 2A C2 - 1 week ago

    Singapore SILICON BOX PTE. LTD. Full time

    Roles & ResponsibilitiesPosition SummarySenior PQC Engineer (incoming / outgoing inspection) is responsible to develop & deploy inspection procedures to ensure conformance of material to be released.Candidates with experience in semiconductor manufacturing environment are encouraged to apply for this position.Key Responsibilities: Develop, plan & coordinate...

  • QA Engineer/Senior Engineer

    2 weeks ago

    Singapore Silicon Box Pte. Ltd. Full time

    Position SummaryQA Engineer/Senior Engineer (Process Quality Control) is responsible to develop & deploy inspection procedures to ensure conformance of material to be released.Candidates with experience in semiconductor manufacturing environment are encouraged to apply for this position.Key Responsibilities:Develop, plan & coordinate incoming/outgoing...

  • Project Engineer

    2 weeks ago

    Singapore Quality Technology Pte. Ltd. Full time

    Salary Range: $3500$4500JOB TITLE: PROJECT ENGINEER / CO-ORDINATORRESPONSIBILITIES:. 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 list to Purchasing...

  • QA Engineer/Senior Engineer

    Found in: Talent SG 2A C2 - 2 weeks ago

    Singapore SILICON BOX PTE. LTD. Full time

    Roles & ResponsibilitiesPosition SummaryQA Engineer/Senior Engineer (Process Quality Control) is responsible to develop & deploy inspection procedures to ensure conformance of material to be released.Candidates with experience in semiconductor manufacturing environment are encouraged to apply for this position.Key Responsibilities: Develop, plan &...

  • Project Engineer

    Found in: Talent SG 2A C2 - 3 weeks ago

    Singapore QUALITY TECHNOLOGY PTE. LTD. Full time

    Roles & ResponsibilitiesSalary Range: $3500~$4500JOB TITLE: PROJECT ENGINEER / CO-ORDINATORRESPONSIBILITIES:· 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,...

  • Quality Engineer

    Found in: Talent SG 2A C2 - 2 weeks ago

    Singapore SEALS TECHNOLOGY ASIA PACIFIC PTE LTD Full time

    Roles & ResponsibilitiesJob Description: Perform incoming, in-process and outgoing inspection activities according to the inspection procedures and plans to ensure compliant to ISO standard. Support on preparation of company QA manual control and supervision of all admendments and revisions. Preparing of Quality Reports for completed jobs. Monitor the...

  • Quality Engineer

    2 weeks ago

    Singapore GE Power Full time

    Job Description SummaryThe 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.Job DescriptionEssential Responsibilities :Key responsibilities...

  • Quality Engineer

    Found in: Talent SG 2A C2 - 3 days ago

    Singapore PEGATRON SERVICE SINGAPORE PTE. LTD. Full time

    Roles & ResponsibilitiesJob 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...

  • Quality Engineer

    2 days 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 need...