Quality Engineer PMS-00000RO9
Description
DePuy Synthes Companies of Johnson & Johnson is the largest, most comprehensive orthopedic and neurological business in the world. DePuy Synthes offer an unparalleled breadth and depth of technology, devices, services and programs in the areas of joint reconstruction, trauma, spine, sports medicine, neurological, cranio-maxillofacial, power tools and biomaterials. Building on the legacy and strengths of two great companies, we are creating one organization that will be agile and better equipped in today’s evolving health care environment. Our broad array of inspired, innovative and high-quality offerings help advance the health and wellbeing of people around the world.
Based in our site in Zuchwil or Oberdorf we are looking for a highly committed
Quality Engineer
As a Quality Engineer you will generate and coordinate Post Market Surveillance activities. You will have responsibilities within DePuy Synthes Trauma, DePuy Synthes CMF and DePuy Synthes Biomaterials to drive compliance for Post Market Surveillance activities, the Safety Surveillance Initiative and for sustaining Quality Engineering activities.
Your main tasks will include:
- perform post-market safety and surveillance activities including trend analyses, signal assessments and product investigations
- execute the Post Market Surveillance process with a primary focus on signal assessment and detailed investigations of potential Safety Issues and Quality Trend Events
- interface with key business partners and coordinate activities as determined by the Safety Surveillance process of Product Development, Medical Affairs, Regulatory Affairs, Operations, Marketing, and the Complaint Handling departments to ensure thorough investigations
- investigations can include user interviews and customer visits to ensure rapid response to field safety issues
Qualifications
- a Bachelor’s Degree in Engineering is required
- a minimum of 2 years’ experience working in a quality system framework (ISO 9001 or similar) is required
- medical device/diagnostic/or pharmaceutical industry experience is required
- experience with Post Market Surveillance/Safety Surveillance activities, previous Design Control experience, working knowledge of reading and interpreting product specifications and experience with statistics/analytics is preferred
- excellent problem solving, root cause analysis and decision-making skills are required
- strong working knowledge of the QSR and ISO quality requirements is preferred
- knowledge of process or design excellence tools with Green or Black Belt training are an advantage
- business fluent in English and good spoken and written German skills are important
- this position may require up to 10% travel within Switzerland
If you feel attracted by this challenge and want to be part of a successful and growing organization, then please send us your online application (CV, Motivation Letter, Working References etc.).
Primary Location:Europe/Middle East/Africa-Switzerland-Solothurn-Zuchwil
Other Locations:Europe/Middle East/Africa-Switzerland-Basel-Country-Oberdorf
Organization: Synthes GmbH (7111)
Job Function: Quality (Eng)
Description
DePuy Synthes Companies of Johnson & Johnson is the largest, most comprehensive orthopedic and neurological business in the world. DePuy Synthes offer an unparalleled breadth and depth of technology, devices, services and programs in the areas of joint reconstruction, trauma, spine, sports medicine, neurological, cranio-maxillofacial, power tools and biomaterials. Building on the legacy and strengths of two great companies, we are creating one organization that will be agile and better equipped in today’s evolving health care environment. Our broad array of inspired, innovative and high-quality offerings help advance the health and wellbeing of people around the world.
Based in our site in Zuchwil or Oberdorf we are looking for a highly committed
Quality Engineer
As a Quality Engineer you will generate and coordinate Post Market Surveillance activities. You will have responsibilities within DePuy Synthes Trauma, DePuy Synthes CMF and DePuy Synthes Biomaterials to drive compliance for Post Market Surveillance activities, the Safety Surveillance Initiative and for sustaining Quality Engineering activities.
Your main tasks will include:
- perform post-market safety and surveillance activities including trend analyses, signal assessments and product investigations
- execute the Post Market Surveillance process with a primary focus on signal assessment and detailed investigations of potential Safety Issues and Quality Trend Events
- interface with key business partners and coordinate activities as determined by the Safety Surveillance process of Product Development, Medical Affairs, Regulatory Affairs, Operations, Marketing, and the Complaint Handling departments to ensure thorough investigations
- investigations can include user interviews and customer visits to ensure rapid response to field safety issues
Qualifications
- a Bachelor’s Degree in Engineering is required
- a minimum of 2 years’ experience working in a quality system framework (ISO 9001 or similar) is required
- medical device/diagnostic/or pharmaceutical industry experience is required
- experience with Post Market Surveillance/Safety Surveillance activities, previous Design Control experience, working knowledge of reading and interpreting product specifications and experience with statistics/analytics is preferred
- excellent problem solving, root cause analysis and decision-making skills are required
- strong working knowledge of the QSR and ISO quality requirements is preferred
- knowledge of process or design excellence tools with Green or Black Belt training are an advantage
- business fluent in English and good spoken and written German skills are important
- this position may require up to 10% travel within Switzerland
If you feel attracted by this challenge and want to be part of a successful and growing organization, then please send us your online application (CV, Motivation Letter, Working References etc.).
Primary Location:Europe/Middle East/Africa-Switzerland-Solothurn-Zuchwil
Other Locations:Europe/Middle East/Africa-Switzerland-Basel-Country-Oberdorf
Organization: Synthes GmbH (7111)
Job Function: Quality (Eng)