Together with colleagues in the region, the Regional QA Engineer, Integrated Solutions APAC, is part of the global QA team that is supporting the Custom Engineering and Integrated Solutions businesses world-wide. This person works as the QA representative for IS projects and project execution at customer sites, supports the effectiveness of the QMS, and liaises with stakeholders in the organization to drive continuous improvement.
This position reports to the QA Director – Custom Engineering & Integrated Solutions and is located in Singapore and will be an on-site role.
What you will do:
- Responsible for driving QA and compliance activities for the Integrated Solutions business in APAC, including but not limited to: Milestone approvals of projects, ensure resources for onsite QA support, act as onsite QA being the customer facing representative from QA
- Manage QMS processes like NC, CAPA, Complaints, document review and support internal/external audits
- Lead and manage validation QA strategy, project QA governance & processes, CIP (Continuous Improvement Project) & LL (Lesson Learnt Initiatives) for IS Business
- Support project performance reviews and develop input to Quality management reviews
- Supports development of training material and delivers training of quality associates and internal teams
Who you are:
- Essential Qualifications/Education: BEng or BSc
- Minimum 5 years of experience in Quality role, preferably in the Life Sciences industry
- Comprehensive understanding of ISO 9001 & cGMP requirements
- Experienced in managing project teams and working cross functionally, both locally & globally.
- Ability to communicate effectively in English plus one other language (for example: Chinese, Korean, Japanese) written and spoken.
Travel, Motor Vehicle Record & Physical/Environment Requirements:
- Ability to travel globally and at short notice up to 50%
- Must have a valid driver’s license
It would be a plus if you also possess previous experience in:
- 5 to 10 years of proven experience as a quality assurance professional in a GMP environment
- Managing teams and direct reports across multiple locations
Cytiva, a Danaher operating company, offers a broad array of comprehensive, competitive benefit programs that add value to our lives. Whether it’s a health care program or paid time off, our programs contribute to life beyond the job. Check out our benefits at Danaher Benefits Info.
Join our winning team today. Together, we’ll accelerate the real-life impact of tomorrow’s science and technology. We partner with customers across the globe to help them solve their most complex challenges, architecting solutions that bring the power of science to life.
For more information, visit www.danaher.com.
Skills Required
- Bachelor of Engineering or Bachelor of Science degree
- At least 5 years of experience in a quality role
- Comprehensive understanding of ISO 9001 requirements
- Comprehensive understanding of cGMP requirements
- Experience managing project teams and working cross-functionally locally and globally
- Effective written and spoken English plus one additional language, such as Chinese, Korean, or Japanese
- Ability to travel globally and at short notice up to 50%
- Valid driver's license
- Five to ten years of quality assurance experience in a GMP environment
- Experience managing teams and direct reports across multiple locations
Danaher Corporation Compensation & Benefits Highlights
The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about Danaher Corporation and has not been reviewed or approved by Danaher Corporation.
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Healthcare Strength — Healthcare coverage is described as comprehensive, including medical plan options alongside dental, vision, life, disability, and mental health support. Wellness initiatives and support programs such as an EAP and vaccination or fitness offerings add breadth beyond core insurance.
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Retirement Support — Retirement benefits include a 401(k) plan with employer matching and options such as pre-tax and Roth contributions. Broader financial rewards such as performance bonuses and access to equity or an employee stock purchase plan are also described.
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Parental & Family Support — Parental leave and family-building support are described as available, including maternity and paternity leave and fertility assistance. Childcare and eldercare support are also highlighted as part of the overall package.
Danaher Corporation Insights
What We Do
Danaher is a global science and technology innovator committed to helping our customers solve complex challenges and improve quality of life around the world. A global network of more than 25 operating companies, we drive meaningful innovation in some of today’s most dynamic industries through our operating companies in four strategic platforms: Life Sciences, Diagnostics, Water Quality and Product Identification. The engine at the heart of our success is the Danaher Business System (DBS), a set of tools that enables continuous improvement around lean, growth and leadership. Through the ingenuity of our people, the power of DBS and the impact of our meaningful technologies, we help realize life’s potential in ourselves and for those we serve.
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