"Alerted.org

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.

The Position

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. 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 the Strategic Quality Partner 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 a Bachelor's degree in Mechanical or Chemical Engineering or a related field

+ You have 3+ years of related experience.

+ You have strong design control/Quality Management System 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.

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

Locations

You are local to the Bay Area and can be at the Roche site in Pleasanton, CA or Santa Clara, CA for at least 3 days a week.

Relocation assistance is not available.

The expected salary range for this position based on the primary location of Pleasanton is $74,000 and $176,500. 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 (https://roche.ehr.com/default.ashx?CLASSNAME=splash)

Who we are

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. It is our policy and practice to employ, promote, and otherwise treat any and all employees and applicants on the basis of merit, qualifications, and competence. The company's policy prohibits unlawful discrimination, including but not limited to, discrimination on the basis of Protected Veteran status, individuals with disabilities status, and consistent with all federal, state, or local laws.

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 (https://docs.google.com/forms/d/e/1FAIpQLSdZWlsbfQOvFVIQgHE\_iDzWUTlhZvj6FytIzjS7xq6IGh1H5g/viewform) .