Design Quality Partner
Roche
full-time
Posted on:
Location Type: Office
Location: Stirling • 🇬🇧 United Kingdom
Visit company websiteJob Level
Mid-LevelSenior
About the role
- Partner closely with project teams to ensure design control deliverables are complete and ready for key project milestones.
- Review and approve development documentation, ensuring accuracy, clarity, and compliance.
- Drive standardisation across projects — including templates, processes, and deliverable quality.
- Support internal and external audits and represent Pre-Market Quality in mQMS communities.
- Oversee design change requests, non-conformances (NCs) and CAPAs, ensuring timely and effective resolution.
- Champion continuous improvement and new ways of working that make our teams stronger and more agile.
Requirements
- A degree in engineering, business administration, or a related field (MBA or advanced degree is an advantage)
- Strong understanding of design control and medical Quality Management Systems (mQMS)
- Knowledge of regulatory standards such as ISO 13485, FDA, and GMP
- Experience reviewing design history files and other key quality deliverables
- Excellent communication and technical writing skills, with an eye for detail and clarity.
Benefits
- Competitive salary
- Health insurance
- 401(k) matching
- Paid time off
- Professional development opportunities
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
design controlmedical Quality Management Systemsregulatory standardsISO 13485FDAGMPdesign history filesquality deliverablestechnical writing
Soft skills
communicationattention to detailclaritycontinuous improvementagility
Certifications
degree in engineeringdegree in business administrationMBAadvanced degree