Principal Design Quality Engineer

Job description

·  Job facts

Process owner for Software Quality Assurance
Leads efforts to improve SQA practices, including software requirements specifications, software architecture, design and development, validation, metrics and technical reviews.
Interacts across organizations, levels, and groups to accomplish job functions.
Participates on cross-functional / multi-site meetings and initiatives, ensures the interdepartmental integration of the quality function for software quality planning.
Contributes to internal, and supplier audits by consultancy or participation.
Contributes to Defect-, CAPA-, and Change Management activities.
Contributes to Reporting and Management Reviews.
Assures local organization is trained on QSR and ISO requirements through the development and implementation of compliance education and training courses.
Interfaces with Regulatory agencies and professional organizations to assure that the Quality System remains current and competitive.
Expected to operate independently, holding him/herself accountable to proactively fulfill tasks and achieve results within assigned timelines.
Expected to understand strategic priorities developed by upper management and to respond to requests with appropriate urgency and with an organized approach.

Qualifications
Bachelors' degree in Informatics / Computer Sciences, Business Administration or related field, or equivalent combination of education and work experience
• Master's degree/PhD, or equivalent preferred
• 4+ years minimum (6+ preferred) of relevant medical diagnostic/device industry experience, including experience focused on quality systems, regulatory affairs/compliance, project management, controlled documentation, product labeling, and/ or change control.
• Thorough working knowledge of relevant international ISO/IEC Standards (13485, 14971, 62304, 62366) and regulations (European medical devices directives, 21 CFR - part 820)
• Familiarity with Software Development methodologies such as Waterfall, Agile, SAFe, AAMI TIR45
Competencies
• Enthusiasm for the role that Quality and Regulatory (Q&R) can play in enabling the development of new products for our patients by contributing in a startup environment
• Drive to engage positively with Q&R/Business teams and make impactful contributions in a multi-cultural/national environment
• Track record of providing sound Q&R judgment/ideas and business partnering
• Strong managerial/interpersonal/integrating/problem-solving skills and demonstrated ability to collaborate

·  Who we are

At Roche, 94,000 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.

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.