Quality System Engineer

For over 170 years, Leica Microsystems has helped shape the future by developing groundbreaking optical and digital solutions. As a global leader, we’re driven by continuous improvement to excite our customers and to create the best work environment for our people. Customer focus, innovation, and teamwork are at the core of our culture and the foundation of our success.

Want to be part of a company whose products are part of cutting-edge research around the world? Join Leica Microsystems in our commitment for brilliant solutions and insight.

Leica Microsystems is one of 10 Life Sciences companies of Danaher. Together, we accelerate the discovery, development and delivery of solutions that safeguard and improve human health.

We currently offer the following position in our office in Singapore which will be on site.

**Quality Systems Engineer
This role is responsible for management of document changes, QMS training, engineering changes, records archiving and overall support in maintenance of the existing Quality Management System (QMS). Also responsible for overall administrative coordination of document and training system.

**Your Responsibilities**
- Support the Global QMS team in ensuring the conformity of QMS to established applicable standards and regulations, conduct internal audits and participate in external audits to verify effectiveness, and drive Quality Systems and compliance training to raise awareness towards Good Manufacturing Practices (GMP) and Good Documentation Practices (GDP).
- Maintain Document Management System (DMS) and Training Management System (TMS), execute document changes and revision controls, maintain compliance of engineering changes and supporting documentation, including execution of QMS-related changes (e.g., BOM changes, Process Documentation release), and create and coordinate training plans in TMS, ensuring training timeliness.
- Ensure archival records are easily retrieved and properly maintained, identified and traceable, update and maintain master list/log sheet of quality records, and coordinate and maintain Quality Records archival and retrieval from Document Management Centre.
- Drive Quality Systems and compliance training to raise awareness towards Good Manufacturing Practices (GMP) and Good Documentation Practices (GDP), create and coordinate training plans in TMS, ensuring training timeliness, and represent RAQA Department in ad-hoc committees and cross functional projects.Adhere to company EHS requirements, regulations and risk assessments and take adequate control measures in preventing injuries to themselves and others, and represent RAQA Department in ad-hoc committees and cross functional projects.

**Your Profile**
- **Educational Background**:Degree in a relevant field such as Quality Management, Engineering, Life Sciences, or a related discipline; diploma holders with equivalent experiences will also be considered.
- **QMS Experience**:Proven experience in maintaining and auditing QMS to ensure compliance with applicable standards and regulations.
- **Document Management System Experience**:Experience in managing Document Management Systems and Training Management Systems, including executing document changes and coordinating training plans, with familiarity in computerized systems (e.g., Trackwise, Windchill) being advantageous.
- **Applicable Standards and Regulations Knowledge**:Strong understanding of Good Manufacturing Practices (GMP) and Good Documentation Practices (GDP), with preferred knowledge in ISO13485, USFDA QSR, cGMP (21 CFR Part 820), and MDSAP.
- **Communication Skills**:Excellent communication skills to work closely with colleagues across departments and represent the RAQA Department in ad-hoc committees and cross-functional projects.\

**What We Offer**
- Equal pay is a given for us.
- Learn all there is about Kaizen, PSP's and Muda as part of our Danaher Business System (DBS) trainings - if you believe in continuous improvement like us
- We have no room for prejudices and stereotypes. We promote equal opportunities, diversity and inclusion.We offer a balance between support and autonomy to achieve your own goals in an international environment.

**Get More Insight**

Are you interested to discover new opportunities in an innovative, team-oriented environment?