Design Quality Partner

F. Hoffmann-La Roche Gruppe; Cape Town; On-site; ZAR 600,000 - 800,000; Full time

Job summary

A global healthcare company in Cape Town is looking for a Design Quality Partner to advance the development of medical devices. You will ensure project milestones are met, standardize best practices across customer areas, and motivate colleagues to foster a culture of innovation and quality. Ideal candidates have a bachelor's degree in a related field and at least 3 years of quality or regulatory experience. Join us in shaping the future of healthcare.

Qualifications

• 3+ years of relevant experience in a quality or regulatory-focused environment.
• Strong understanding of design control/mQMS principles.
• Exceptional technical writing and data interpretation skills.

Responsibilities

• Collaborate with SQPs to evaluate and sign off on key deliverables.
• Drive standardization of processes across customer areas.
• Contribute during internal and external audits.

Skills

Detail-Oriented

Technical Mastery

Influential Collaborator

Knowledgeable Risk-Taker

Education

Bachelor's degree in engineering or business administration

Tools

ISO 13485

FDA standards

GMP standards

Job description

Overview

At Roche you can show up as yourself, embraced for the unique qualities you bring. Our culture encourages personal expression, open dialogue, and genuine connections, where you are valued, accepted and respected for who you are, allowing you to thrive both personally and professionally. 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.

Position

Are you ready to make an impact in the world of healthcare by ensuring innovative and high-quality solutions reach patients who need them? Roche in Cape Town is looking for a motivated and talented Design Quality Partner (DQP) to join our Product Development Quality team. If you're passionate about bridging partnerships, driving excellence, and enabling innovation, this might just be the role for you.

Main Purpose

As our Design Quality Partner, you will play a critical role in advancing the development of cutting-edge medical devices, including assays, software, hardware, and instruments. Your mission is to foster effective partnerships across Quality & Regulatory (Q&R) and related teams to streamline project execution, accelerate timelines, and ensure the delivery of high-quality design control deliverables. Ultimately, you'll be a driving force behind timely landmark achievements while enabling documentation efficiency and balancing project workloads.

As a true champion of collaborative success, you'll work together with others to achieve ambitious goals. Empower others, build meaningful connections, and help us create exceptional solutions for patients around the globe.

Key Challenges

• Ensuring Alignment and Readiness: Collaborate with SQPs and key stakeholders to evaluate and sign off on key deliverables, ensuring every project milestone is achieved with rigor and precision.




• Standardizing Best Practices: Drive the standardization of processes and templates across customer areas to create smooth, consistent, and efficient ways of working.




• Navigating Complexities: Contribute meaningfully during internal and external audits, representing Pre-Market Quality in mQMS Communities.




• Prioritizing Quality and Agility: Manage design changes, NCs, and CAPAs with a strong focus on timeliness and optimal process management.




• Fostering Continuous Improvements and Knowledge Sharing: Build a culture of innovation, collaboration, and improvement by embedding knowledge management tools and driving change management rigorously.




• Coaching and Leadership: Motivate, coach, and empower colleagues, creating a developmental environment that ensures lasting success.

Qualifications & Ideal Candidate

You thrive in dynamic environments and embrace challenges with an innovative mindset. You will bring the following skills, experiences, and qualities to our team:

• Educational Background: A bachelor’s degree in engineering, business administration, or a related field (an MBA or advanced degree is a bonus!).




• Experience: At least 3+ years of relevant experience within a quality or regulatory-focused environment.




• Technical Mastery: Strong understanding of design control/mQMS principles and familiarity with Quality and Regulatory standards (ISO 13485, FDA, GMP, etc.), along with expertise in reviewing design history files.




• Detail-Oriented: Exceptional technical writing and data interpretation skills with a keen eye for balancing detail and efficiency.




• Influential Collaborator: An inspiring leader with exceptional decision-making skills, who fosters teamwork, agility, and adaptability.




• Knowledgeable Risk-Taker: You possess the expertise to navigate design changes smoothly while leveraging a continuous improvement mindset to address risks creatively.

Step into a role where your contributions directly impact patient lives. Be part of a diverse and forward-thinking culture at Roche’s Cape Town facility. Together, let’s drive innovation, ensure quality, and shape the future of healthcare.

Are you ready to be our next Design Quality Partner? Join Roche and help us deliver on our purpose: doing now what patients need next.

About Roche

A healthier future drives us to innovate. Together, more than 100’000 employees across the globe are dedicated to advance science, ensuring everyone has access to healthcare today and for generations to come. Our efforts result in more than 26 million people treated with our medicines and over 30 billion tests conducted using our Diagnostics products. We empower each other to explore new possibilities, foster creativity, and keep our ambitions high, so we can deliver life-changing healthcare solutions that make a global impact.

Let’s build a healthier future, together.

Roche is an Equal Opportunity Employer.