Join to apply for the
Design Quality Partner
role at
Roche
At Roche you can show up as yourself, embraced for the unique qualities you bring. This is how we aim to prevent, stop and cure diseases and ensure everyone has access to healthcare today and for generations to come. Join Roche, where every voice matters.
Overview The Opportunity: We are hiring for a
Design Quality Partner
to join our Product Development Quality operation to support software and hardware development of new medical devices.
Responsibilities
Partner with SQP and applicable collaborators to ensure completeness and appropriateness of applicable achievement deliverables to ensure landmark readiness and achievement
Review and approve achievement deliverables within development projects
Represent Pre Market Quality in mQMS Communities and support internal and external audits
Drive standardization of deliverables across all projects and Customer areas (i.e. templates, review process, content, other)
Ensure timely execution and quality process management for design change requests, NCs and CAPA
Models behavior to support and enable new ways of working and a culture of continuous improvement
Other responsibilities
Embed and continuously improve knowledge management within Pre Market Quality, fostering effective sharing and retention of knowledge and expertise
Ensure effective change management in Product Development Quality, R&D and other functions
Foster a culture of innovation and continuous improvement across Product Development Quality and other functions
Serve as a role model, supporting the transition to a new operating model emphasizing agility, collaboration, and adaptability
Drive decision-making, ensuring timely and informed decisions are made, and obtaining commitment for implementation
Serve as a coach, supporting colleagues to grow and develop their skills
Qualifications
Bachelor's degree in engineering, business administration or a related field and 3+ years experience or MBA or advanced degree is considered an advantage
Strong design control/mQMS understanding
Knowledge and understanding of Quality and Regulatory requirements for review of design history file
Content
Knowledge of Regulations pertaining to the environment (i.e. ISO 13485, FDA, GMP, others)
Technical writing and data interpretation skills, including ability to focus on the right degree of detail when reviewing deliverables
Preferred experience in software and hardware for medical devices
Location:
Sant Cugat del Vallès
Leadership and Operating Principles
Put patients first
Follow the science
Act as one team
Embrace differences
Accelerate learning
Simplify radically
Make impact now
Think long term
Roche is an Equal Opportunity Employer.
Details
Seniority level: Associate
Employment type: Full-time
Job function: Quality Assurance
Industries: Pharmaceutical Manufacturing, Biotechnology Research, and Medical Equipment Manufacturing
End of posting
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