Regional QA Engineer, Integrated Solutions

Danaher Corporation; Singapore; On-site; SGD 90,000 - 130,000; Full time

Job summary

Cytiva, a Danaher operating company, is seeking a Regional QA Engineer for Integrated Solutions APAC. Based in Singapore, the role is on-site and acts as QA representative for IS projects, driving QMS effectiveness and continuous improvement with stakeholders worldwide.

You will support project performance reviews, develop quality inputs for management reviews, and help train teams on quality concepts. Travel up to 50% may be required.

Qualifications

• Bachelor's degree in engineering.
• Minimum 5 years of experience in quality roles.
• Comprehensive understanding of ISO 9001 and cGMP requirements.
• Experience in leading cross-functional teams and QA governance.

Responsibilities

• Drive QA and compliance activities for APAC IS projects, including milestone approvals and onsite QA support.
• Manage QMS processes: NC, CAPA, Complaints, document reviews, audits.
• Lead validation QA strategy, governance, CIP and LL initiatives.

Skills

Quality Assurance

GMP

ISO 9001

Cross-functional

QA governance

Education

BEng or BSc

Job description

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 (https://leplb1040.upoint.alight.com/ah-angular-afirst-web/#/web/danaher/cp/preauth-home) .

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 .