Singapore/Jobs/Senior Engineer – Operational Quality & Compliance/

Senior Engineer – Operational Quality & Compliance 316494

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$5300 to $10600 (Monthly)

Posted a year ago

Veranome Biosystems LLC, an Applied Materials company, provides the spatial analysis market with a reliable, easy-to-use, end-to-end multi-omics solution. We enable researchers to deepen their understanding of diseases with high-quality data of how individual cells organize within tissue, using robust workflows, reliable imaging systems and without the need for extensive bioinformatics tools or infrastructure. Veranome’s unique combination of genomics expertise and world-class high-speed diffraction limited optical imaging capabilities enables researchers to access in-situ spatial omics and elucidate reliable disease insights with unsurpassed data quality.

Job Summary:

In this challenging but rewarding career opportunity, you will work with system engineers, bench scientists and other engineers to drive operational excellence and quality compliance for the services and manufacturing of our high-throughput bioimaging platform.

You should have a flexible and learning mindset, be able to work in a fluid and dynamic environment, be comfortable working with globally distributed development and operation teams and have a strong desire to pursue creative solutions to challenging problems. This requires you to:

  • Setup and update procedures, systems or processes to trend and monitor service and manufacturing performance. Devise procedures, forms for recording, evaluating and reporting quality and reliable data.

  • Setup and sustain engineering change controls, deviation management, document change management and QC

  • Ensures adequacy of non-conformances and CAPA records

  • Drive process risk management activities and ensure completeness of device master record, production batch records, engineering study report, validation packages, change orders and customer service report

  • Maintain the Quality Procedures and ensure contents are appropriate for business. Drive management system update due to customer, ISO and regulatory requirements

  • Coordinate and drives audit closures from customer, certification body, internal audit and regulatory body

  • Drive product risk management activities and ensure quality and completeness of validation packages, and change orders for NPI or transfers

  • Ensure that the processes are compliant with Quality System and EHS requirements efficiently

  • Coordinate investigations associated with field complaints and customer returns

  • May coordinate outsourcing activities with external / internal suppliers.

  • Drives Process Failure Mode, Effects and Criticality Analysis when working with New Product Transfer and sustaining activity.

  • May provide leadership and mentor junior staff to resolve routine issues

All listed tasks and responsibilities are deemed as essential functions to this position. However, business conditions may require reasonable accommodation for additional tasks and responsibilities

Education and Experience:

We welcome applicants with Engineering, or Life Sciences related degrees. >5 years of relevant working experience in manufacturing environment is a plus.

Key Competencies:

  • Ability to develop procedures to meet requirement of cGMP, ISO9001 or ISO13485 Standard.

  • Experience in manufacturing operations, QC/QA or service testing. Individual with CQE or Six-Sigma certification is a plus

  • May have experience with statistical analysis packages. Eg. JMP, Minitab. Expertise in at least one scripting languages such as MATLAB (preferred), Python or R for pipelines and complex data analysis is a plus.

  • Experience with electronic Product Life Cycle (PLM), enterprise resource planning tools (SAP) and Quality Management System.

  • Experience with applying QC tools (ie. 8D, DMAIC) to improve efficiency and root cause investigation.

  • Intermediate to advance level of knowledge in FMEA, Statistical Process Control, Gauge R&R

  • May have experience with biochemical assays, cell culture and analytical tools.

  • Demonstrate leadership as a change agent.

  • Highly effective planning, prioritization, organization and implementation skills

  • Able to establish working relationships across functions to achieve business objectives

  • Excellent written and verbal communication skills.

  • Fluent in English.

This position is located in Singapore and report directly to the Operations Manager in Singapore. Some travel is required.

If you have questions about this job, please click on apply. The employer will contact you then.


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