Senior Design Quality Assurance Manager

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

Roche Sequencing Solutions, Inc. seeks a Senior Design Quality Assurance Manager at its Tucson, Arizona location.

Duties : Partner with Global Quality and Regulatory and Roche Information Solutions (RIS) functions to ensure Software Design Controls and Software Development Life Cycle Management compliance with FDA Quality System Regulation (QSR) and International Standards Organization (ISO) regulations. Act as process owner for Software Quality Assurance (SQA). Lead efforts to improve SQA practices, including software requirements specifications, software architecture, design and development, validation, metrics and technical reviews. Interact across organizations, levels, and groups to accomplish job functions. Participates in cross-functional / multi-site meetings and initiatives and ensure interdepartmental integration of the quality function for software quality planning. Contribute to internal and supplier audits by consultancy or participation. Contribute to Defect-, CAPA-, and Change Management activities. Contribute to Reporting and Management Reviews. Assure local organization is trained on QSR and ISO requirements through the development and implementation of compliance education and training courses. Interface with Regulatory agencies and professional organizations to assure that the Quality System remains current and competitive. May telecommute up to 2 days per week

Education and experience required : Bachelor's degree or foreign equivalent in Mechanical Engineering, Informatics, Computer Engineering or related field, and 5 years of progressive post-bachelor's experience in related role in medical device or diagnostic quality systems.

Special Requirements : Must have experience with the following :

• 1. Experience in the medical diagnostic / device industry, including experience focused on quality systems, regulatory affairs / compliance, project management, controlled documentation, product labeling, and / or change control;
• 2. Working within relevant international ISO / IEC Standards (13485, 14971, 62304, 62366) and regulations (European medical devices directives, 21 CFR Part 820, FDA 21 CFR Part 11) to validate and review validation of tools / software, and to review design and development activities and deliverables;

3. Using software development methodologies and processes such as Waterfall, Agile, SCRUM, SAFe, AAMI TIR45 Competencies to manage and execute projects.

May telecommute up to 2 days per week

Worksite : 1910 E Innovation Park Drive, Tucson AZ 85755

The expected annual salary range for this position based on the primary location for this position of Tucson is $128,064 to $159,900 per year. Actual pay within the range 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 ( )

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.

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