2 дня назад
Senior Supplier Quality Engineer (In-Vitro Diagnostics)
Вакансия из Hirify Global, списка международных tech-компанийДля мэтча и отклика нужен Plus
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Senior Supplier Quality Engineer (In-Vitro Diagnostics): Leading supplier selection, qualification, audits, and quality improvement for purchased materials and services in a regulated genomics environment with an accent on supplier development, risk management, and compliance with FDA and ISO requirements. Focus on leading failure investigations, corrective actions, process validation, material qualification, and transferring suppliers from development to production.
Location: Singapore - Woodlands - NorthTech. Full-time onsite position with approximately 25% domestic and international travel.
Company
develops genomic technology that supports early disease detection, diagnosis, treatment options, and broader health equity.
What you will do
- Select new suppliers and lead supplier evaluation, qualification, and development activities.
- Support new product development and sustaining teams in designing and releasing reliable, safe products.
- Lead purchased-material qualification and requalification, including process validation, first article inspection, measurement gauge analysis, and capability studies.
- Conduct supplier audits, drive process standardization, and improve supplier and purchased-material performance.
- Lead failure investigations and ensure timely implementation of mitigations, corrective actions, CAPA, and SCAR activities.
- Maintain quality metrics, update purchasing controls, train team members, and ensure effective supplier transfers from development to production.
Requirements
- Demonstrated experience in supplier quality and supplier management, including component qualification, audits, and risk assessments.
- Experience with non-conformance handling, failure investigation, CAPA, SCAR, FMEA, and risk management.
- Experience collaborating with cross-functional product development and operational teams, with strong communication and negotiation skills.
- Experience with quality, project management, and process engineering methodologies and tools.
- Experience with electronic product lifecycle systems such as Agile or SAP.
- Ability to lead change, resolve risks, work in a fast-paced environment, and travel domestically and internationally as needed.
Nice to have
- BS or equivalent in a technical discipline with 5+ years of experience, or MS/PhD with 3+ years of experience.
- Experience in FDA- and ISO-regulated environments.
- Experience with JMP or Minitab statistical analysis packages.
- Experience in a regulated in-vitro diagnostics environment.
Culture & Benefits
- Inclusive environment focused on belonging, openness, collaboration, and diverse perspectives.
- Employee Resource Groups provide career development, cultural awareness, and social responsibility opportunities.
- Commitment to equal employment opportunity and pay equity.
- Background checks may be conducted after a conditional offer.
- Generative AI is prohibited during the application and interview process.
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