Danaher Corporation Global Project Leader RA/QA in Singapore, Singapore
Leica Microsystems has helped shape the future of microscopy for over 170 years 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 proud to work alongside a community of nine fellow Danaher Life Sciences companies. Together, we’re pioneering the future of science and medicine, developing products that enable researchers in the fight to save lives.
The Global Project Leader will lead critical RA/QA projects and represents the department in high priority global projects include software tools, sites relocation, etc. The incumbent will work closely with R&D, RAQA, Industrial Engineering, Manufacturing and Service to ensure continuous improvement of quality relevant processes. He/she will identify opportunities to harmonize and standardize processes among different sites (e.g. Software Tool Validation, Training, Labeling, etc.). as well as lead/coordinate workshops and Kaizens to achieve sustainable improvement.
Identification of opportunities for process improvement
Collaborating closely with relevant stakeholders to harmonize and improve processes.
Supporting implementation of Quality relevant Software tools
Managing cross-functional RA/QA projects
Planning, monitoring progress and communicating with the project team and management
Qualifications and Skills:
The successful candidate will have the following qualifications and skills:
Minimum overall 10 years of RA and/or QA experience with good exposure in the medical device industry.
Experience with active medical devices
Experience in leading continuous improvement projects in a matrix organization
Experience in organizing and conducting workshops and training
Experience in working with ISO 13485, MDD, MDR and FDA 21 CFR
Experience in holding presentations and training
Experience with Validation
Lean or Six Sigma experience with an emphasis on the development of standard work
A degree from a technical college or university required
Knowledge of US and EU medical device regulatory requirements
ASQ, six sigma, lean certification would be a plus
PERSONAL TRAIT PROFILE
High level of emotional intelligence
Ability to listen to others as well as communicate verbally and in writing across all levels of the organization
Proactive; takes ownership and is accountable
Strong analytical and organizational skills
Team player with the ability to work independently
Proven leadership skills with the ability to take the lead in a team
Strong problem-solving skills; Ability to make good decisions and exercise good judgement
Well organized, able to prioritize and able to see the big picture
High level of integrity
Strong quality focus, ethical foundation and a sound compliance understanding.
Attention to detail/detail-oriented; structured, data-driven decision making
The hands-on mentality in combination with a solution-oriented mindset
Ability to adapt to a growing and changing organization
Global mindset and an inert drive for success
GET MORE INSIGHT
Learn more about what we do and who we are by watching our company video “We Are Leica”: https://www.youtube.com/watch?v=1zHmalqMXN4
Are you interested to discover new opportunities in an innovative, team-oriented environment? Do apply online with your complete documents (cover letter, CV, certificates). We are looking forward to your application!
When you join us, you’ll also be joining Danaher’s global organization, where 69,000 people wake up every day determined to help our customers win. As an associate, you’ll try new things, work hard, and advance your skills with guidance from dedicated leaders, all with the support of powerful Danaher Business System tools and the stability of a tested organization.
Danaher is committed to a diverse and inclusive culture where everyone feels they belong and all voices are heard. We believe in our associates and the unique perspectives they bring to every challenge, which is why we’ll empower you to push the boundaries of what’s possible.
If you’ve ever wondered what’s within you, there’s no better time to find out.
Danaher Corporation and all Danaher Companies are equal opportunity employers that evaluate qualified applicants without regard to race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law. The “EEO is the Law” poster is available here (http://www.dol.gov/ofccp/regs/compliance/posters/pdf/eeopost.pdf) .