Senior Quality Engineer, Pqe
2 weeks ago
Job Description
**Bring more to life.**
Are you ready to accelerate your potential and make a real difference within life sciences, diagnostics and biotechnology?
At Leica Microsystems, one of Danaher’s 15+ operating companies, our work saves lives—and we’re all united by a shared commitment to innovate for tangible impact.
You’ll thrive in a culture of belonging where you and your unique viewpoint matter. And by harnessing Danaher’s system of continuous improvement, you help turn ideas into impact - innovating at the speed of life.
Shape the Future with Us
At Leica Microsystems, we have been shaping the future for over 175 years with groundbreaking optical and digital solutions. With a culture rooted in customer focus, innovation, and teamwork, we lead the market in microscopy, imaging, and analysis, unveiling the invisible and empowering our customers to build a better, healthier world.
Joining Leica Microsystems means contributing to scientific discoveries and supporting surgeons in making critical decisions. Our advanced microscopes and AI-based image analysis solutions enable users to gain profound insights into development and engineering challenges. Here, you will work on meaningful projects alongside passionate colleagues, driving progress and pushing the boundaries of what’s possible.
Learn about the Danaher Business System which makes everything possible.
This position reports to the Senior Manager Quality Assurance and is part of the Production Quality Engineering (PQE) team located in Singapore and will be an on-site role.
**In this role, you will have the opportunity to**:
- Address production quality issues by identifying problems and collaborating with cross-functional teams to develop solutions for overall product quality improvement.
- Utilize statistical tools to identify trends and patterns for enhancing the production process and ensuring quality.
- Investigate and correct root causes of product failures occurring in the field.
- Conduct periodic production audits to ensure compliance with established policies, procedures, and control plans.
- Participate in lean and continuous improvement initiatives, while adhering to company EHS requirements to prevent injuries and maintain safety.
**The essential requirements of the job include**:
- Bachelor's degree in Mechatronics, Mechanical Engineering, or Electronics.
- At least 5 years of relevant experience in biomedical or medical device manufacturing.
- Proficient in statistical control methods and QMS 9001; familiarity with ISO13485, USFDA QSR/cGMP, and ISO14971 for medical devices is advantageous.
- Computer literate in MS Office and Lotus Notes.
- Strong analytical, problem-solving skills, and knowledge of lean and investigation tools such as 8D and fishbone diagrams, with a solid understanding of engineering principles, theories, and concepts.
Leica Microsystems, 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.
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