Designer
Universal Music Group, Inc.
Design Quality Partner
Roche
full-time
Posted on:
Location Type: Hybrid
Location: Pleasanton • California • 🇺🇸 United States
Visit company websiteSalary
💰 $74,000 - $176,500 per year
Job Level
Mid-LevelSenior
About the role
- Ensure effective partnerships within Q&R and related functions
- Enable project acceleration by efficient and timely milestone achievement
- Enable an efficient document review process focusing on design control deliverables
- Partner with the Strategic Quality Partner and stakeholders to ensure milestone readiness and achievement
- Review and approve milestone deliverables within development projects
- Represent Pre Market Quality in mQMS Communities of Practice
- Support internal and external audits
- Drive standardization of deliverables across projects and Customer areas
- Ensure timely execution and quality process management for design change requests, NCs and CAPA
- Model behavior to support and enable new ways of working and a culture of continuous improvement
- Adopt Risk Enabler in decision making
- Reduce complexity and drive continuous improvement across customer areas
Requirements
- Bachelor's degree in Mechanical or Chemical Engineering or a related field
- 3+ years of related experience
- Strong design control/Quality Management System 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
- Background in matrix-leadership for a global project team
- Preferred Mandarin language proficiency is considered an advantage
- Experience supporting the design and development of Hardware and Software systems and assay development is considered an advantage.
- Experience working in a global setting is considered an advantage
- MBA or advanced degree is considered an advantage
Benefits
- A discretionary annual bonus may be available based on individual and Company performance
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
design controlQuality Management Systemtechnical writingdata interpretationhardware systems developmentsoftware systems developmentassay developmentregulatory compliancerisk managementproject management
Soft skills
partnership buildingmilestone achievementcontinuous improvementmatrix leadershipcommunicationcollaborationproblem solvingadaptabilityorganizational skillscultural awareness
Certifications
Bachelor's degree in Mechanical EngineeringBachelor's degree in Chemical EngineeringMBA or advanced degreeISO 13485 certificationFDA compliance trainingGMP certificationQuality Management certificationRisk Management certificationTechnical writing certificationRegulatory Affairs certification
