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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