94 days ago on jobs.prismond.com

Design Control QA Engineer

Prismond Group AG

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 Please refer to JobSuchmaschine in your application

Design Control QA Engineer

Practice:  Medical Devices





Country:  Switzerland



Location: Zurich / Zug





We offer flat hierarchies, consulting with a partnership approach and a close-knit family atmosphere





DHF Expert - Medical Devices



Join a successful and fast growing Life Science consultancy where there is plenty of career growth opportunities



New kind of Life Science consultancy 



Multiple and exciting projects



Fast growing Swiss Company



Be involved in a variety of interesting and challenging projects and work within a team; not as an individual





Family atmosphere





Your mission



As the incumbent of this role within Prismond, your challenge will be to guide and support our medical device clients and enabling functions to always do the right thing. This involves being a confident advisor on FDA/EU regulatory compliance and quality management related topics, in order to achieve timely releases of innovative products that deliver high quality and outstanding reliability to the lives they will improve

Therefore, you will support product development programs (new and sustaining) of our Prismond clients. Lead proactive design assurance activities facilitating the development and release of high quality products.  Provide technical expertise in the area of design assurance to Engineering, Operations, Customer Service, Field Service personnel and other business partners. Guide, coach and train respective to investigative methods, risk mitigation techniques, and general product safety



In your role you are supporting our clients and project teams by:

  • Being an integral member of product development team(s) responsible for supporting activities required to ensure product quality of the design through compliance with design controls
  • Support FDA compliance assessments / creation of the DHF and other program files to ensure quality and regulatory requirements are achieved and ensuring DHF completeness
  • Participate in the defects classification, defect risk analysis and investigations
  • Participate in reviews related to design, validation, defect classification and documentation
  • Responsible for ensuring defects, design changes and document changes are processed timely and compliantly as applicable
  • Work with a cross-functional, collaborative, team-based environment; work with multiple sites in various locations, time zones, and countries.
  • Support our program managers with identification and maintenance of program team interdependencies


Roles & responsibilities





F





Focused in Life Science





a dedicated service provider in the medical device, pharma and healthcare industry



Strong Working Culture 



Senior Experts & International Teams





International footprint of teams, subject matter experts and track-record of successful projects





We believe that real consulting starts by bringing more to projects than just bodies. With our deep industry knowledge we develop smart added-value solutions focused on project and personal goals



Prismond at a glance...



Life Science Compliance Services



Strong engaged collaborative style, exceptional and passionate people committed to quality and providing sustainable value



Prismond, is a MedTech, Pharma and Healthcare Service Provider; linking Compliance Services, Product Certification and Commercialization with deep Life Sciences industry knowledge.

We offer our clients lean and sustainable solutions to the most relevant business challenges. Prismond has a strong engaged collaborative style, exceptional and passionate people committed to quality and providing sustainable value to our clients.

Flat hierarchies, advisory services with a partnership approach and a close-knit family atmosphere are essential elements of our company culture. We promote career development and invest in our people.

We have project offices in Zurich, Zug, Lugano, Würzburg, New York and very soon in Hong Kong.

Visit our website for more information:  www.prismond.ch





The Prismond Group





Dedicated Solutions & Tools 





Always Thinking One Step Ahead 





Our motto: to always think one step ahead. What sets us apart and what our clients notice immediately is our curiosity, boldness, sense of responsibility and motivation





What we are looking for



Soft/Consulting skills



  • Bachelor's degree in engineering/science discipline or technical certification in related field
  • 3-5 years of relevant experience in product design and development or related work experience
  • Experience as a contributing member of a team to take design from concept into production
  • Experience with medical device regulations
  • Regulatory compliance awareness such as FDA design controls CFR 820, ISO 14971, ISO 13485, IEC60601, IEC62304 and similar
    ·          CRE / CQE Certification
    ·          Minitab experience
    ·          Statistics background
    ·          Six Sigma / Design for Reliability


Qualifications



  • Regulatory compliance awareness including design controls and risk management in a regulated industry
  • Strong technical skills with demonstrated ability to provide solutions to a variety of technical problems of moderate scope and complexity
  • Ability to learn quickly and respond to changing priorities
  • Must have strong interpersonal communication skills as well as being a motivated team player
  • Ability to work with global QA, RA organization
  • Technical writing and presentation skills
  • Good verbal and written communication skills, good team skills including project management
  • Experienced with basic PC skills (MS Word, Excel, PowerPoint, and Project)
  • Excellent oral and technical writing skills in English
  • Strong problem solving skills




Prismond provides three training programs. From the basics through the continuous on project training: before-during-after the project with our SJ coaching program to the ad-hoc specialization with certificates





Prismond Benefits



Partnership approach



All hands





Celebrate together our company wins and other achievement is in our credo. We plan regular events to share relevant updates, welcome our newest hires and host guest speakers



Working for Prismond is fun and challenging at the same time. We provide a nice working environment which includes our trendy project offices, free drinks, a modern working culture, company success participation and above-average social security benefits



Individual training



Apple or Dell



Flat hierarchies, consulting with a partnership approach and a close-knit family atmosphere are essential elements of our company culture





Super Fridays





At Prismond the "Super Friday" culture is celebrated and kept alive. This allows you to see your co-workers regularly outside of ongoing projects





Modern employment package



At Prismond you can choose from day one if you prefer working with an Apple MacBook or a DELL Windows notebook. In addition, we provide all our employees a laptop Re-Buy program



Join our Prismond family



Human Resources, Prismond Group



"The strength of the team is each member. The strength of each member is the team. Our Prismond team looks forward to receiving your CV"



Tina F.





You can differentiate Prismond from the pack. Whether you are a graduate or an experienced professional, if you feel you would thrive in our environment, we would be pleased to hear from you.

Please submit your online application in English or German. For further information, 

please contact our local Human Resources department.





Prismond Group AG (HQ)

Baarerstrasse 10

6304 Zug

Switzerland

Website:

www.prismond.ch/take-action

Your Application:

Please submit your application online.



Take action - apply now!



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