Design Quality Partner

Roche fosters diversity, equity and inclusion, representing the communities we serve. When dealing with healthcare on a global scale, diversity is an essential ingredient to success. We believe that inclusion is key to understanding people's varied healthcare needs. Together, we embrace individuality and share a passion for exceptional care. Join Roche, where every voice matters.

A healthier future. It's what drives us to innovate. To continuously advance science and ensure everyone has access to the healthcare they need today and for generations to come. Creating a world where we all have more time with the people we love. That's what makes us Roche.

Quality is a competitive advantage for Roche. It allows us to deliver high-quality products to patients, ensures our right to operate, and helps us create value through process excellence and continual improvement efforts. Quality is every patient's right and every employee's responsibility. Our Chapter in Pre-Market Quality is accountable for providing quality support to Development Projects to ensure quality, and filing readiness according to internal and external requirements.

We are seeking a highly motivated Design Quality Partner (DQP) to join our Product Development Quality organization, reporting to the Subchapter Lead Product Development Quality.

The Opportunity

As DQP, you will be responsible for ensuring effective partnerships within Q&R and related functions, enabling project acceleration by efficient and timely milestone achievement. You enable an efficient document review process by focusing on the output of the design control deliverables and balancing project workload across the customer areas through flexible workload allocation. You are an example of living collective success by working, trusting and empowering each other.

• You will partner with SQP and applicable stakeholders to ensure completeness and appropriateness of applicable milestone deliverables to ensure milestone readiness and achievement.

• You will review and approve milestone deliverables within development projects.

• You will represent Pre Market Quality in mQMS Communities of Practice (e.g. for IRM/ Change Control/ D&D module).

• You will support internal and external audits.

• You will drive standardization of deliverables across all projects and Customer areas (i.e. templates, review process, content, other).

• You will ensure timely execution and quality process management for design change requests, NCs and CAPA.

• You will model behavior to support and enable new ways of working and a culture of continuous improvement.

• You will adopt Risk Enabler in decision making.

• You will reduce complexity and drive continuous improvement across customer areas with pragmatic solutions.

Who You Are

• You bring with a Bachelor's degree in Engineering, Business administration or a related field and 3+ years experience or MBA or advanced degree is considered an advantage

• You have strong design control/mQMS understanding

• You have knowledge and understanding of Quality and Regulatory requirements for review of design history file content

• You have knowledge of Regulations pertaining to the environment (i.e. ISO 13485, FDA, GMP, others)

• You hold technical writing and data interpretation skills, including ability to focus on the right degree of detail when reviewing deliverables

• You have a background in matrix-leadership for a global project team.

• You are skilled in communication, collaboration and facilitation.

Locations

You are local to Tucson, Arizona.

Relocation assistance is not available.

The expected salary range for this position based on the primary location of Arizona is between $64,400 and $153,000. Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law. A discretionary annual bonus may be available based on individual and Company performance. This position also qualifies for the benefits detailed at the link provided below.

Benefits

At Roche, more than 100,000 people across 100 countries are pushing back the frontiers of healthcare. Working together, we've become one of the world's leading research-focused healthcare groups. Our success is built on innovation, curiosity and diversity.

Ventana Medical Systems, Inc. (Ventana), a member of the Roche Group, innovates and manufactures instruments and reagents that automate tissue processing and slide staining for cancer diagnostics. Our integrated staining, workflow management and digital pathology solutions optimize laboratory efficiency to reduce errors and support diagnosis for pathology professionals. Together with Roche, Ventana is driving personalized healthcare through accelerated drug discovery and companion diagnostics.

Roche is an equal opportunity employer and strictly prohibits unlawful discrimination based upon an individual's race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, mental/physical disability, medical condition, marital status, veteran status, or any other characteristic protected by law.

If you have a disability and need an accommodation in relation to the online application process, please contact us by completing this form Accommodations for Applicants.