Danaher Corporation Global Project Leader RA/QA (m/f/d) in Heerbrugg, Switzerland
Leica Microsystems has helped shape the future 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.
In this newly established role at our Heerbrugg site, the Global Project Leader RA/QA (m/f/d) will be responsible to:
lead critical RA/QA projects and represent the department in high priority global projects such as relocation of manufacturing site in Singapore , implementation of software tools etc.
work closely with R&D, RAQA, Industrial Engineering, Manufacturing and Service to ensure continuous improvement of quality relevant processes.
find 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.
If this does sound like your next challenge, we are looking forward to meeting you!
The successful candidate will have the following qualifications and skills:
A degree (Bachelor or Master) from a technical college or university
Several years of RA and/or QA experience with good exposure in the medical device industry
Strong knowledge of US and EU medical device regulatory requirements
Familiarity with ISO 13485, MDD, MDR and FDA 21 CFR
Project Management skills and experience with managing cross-functional RA/QA projects
Experience with CAPA management in medical device industry would be beneficial
Experience in organizing and conducting workshops and trainings
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
Fluent in English language, knowledge of German would be a plus
Proactive; takes ownership and is accountable
Strong analytical and organizational skills
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
Strong quality focus, ethical foundation and a sound compliance understanding
Attention to detail, structured, data-driven decision making
Ability to adapt to a growing and changing organization
What we offer
Independent work approach in a driven international team environment
The chance to implement your own ideas
Personal development and numerous training opportunities to choose from
An exciting, holistic task within a global environment and an opportunity to work with leading edge technology and high-end products
An attractive remuneration package and flexible working hours
Work-life-balance that works for everybody due to flexible working hours and opportunity for remote working
Global mentality and an inert drive for success
We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.
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.
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 (https://www.danaher.com/how-we-work/danaher-business-system) tools and the stability of a tested organization.At Danaher, we value diversity and the existence of similarities and differences, both visible and not, found in our workforce, workplace and throughout the markets we serve. Our associates, customers and shareholders contribute unique and different perspectives as a result of these diverse attributes.If you’ve ever wondered what’s within you, there’s no better time to find out.