Senior Design Quality Engineer

Job description

  Job facts

Responsibilities
·  Provide design control and software/systems development guidance to Personalized Health Care software development teams and life cycle teams and be the single point representative for Design Quality Assurance activities on PHC software development project teams. May be a core team member on a Life Cycle Team(s).
·  Review and approve documentation consistent with design control regulations and guidance's dealing with systems/software development, verification and validation practices and GPS design control policy and SOPs. Documentation to include but not limited to DHF documents such as customer requirements, product requirements, design and development plans and reports, verification and validation plans and reports, design transfer documents, labeling, risk management plans and reports, project plans and milestone documentation.
·  Convey information from meetings and other communications to Quality Management to inform management of critical issues and to assure consistent feedback to teams which is in alignment with Quality Management policy.
·  Author and, or review/approve Quality Plan and Report at milestones DI, DO and LD. Assist management in assessment of whether project has met requirements to pass milestone.

·  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.

If you have a disability and need an accommodation in connection with the on-line application process, please email us at .
EEO is the Law

PAY TRANSPARENCY NONDISCRIMINATION PROVISION
The contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor's legal duty to furnish information. 41 CFR 60-1.35(c)

Desired profile

Who you are

You're someone who wants to influence your own development. You're looking for a company where you have the opportunity to pursue your interests across functions and geographies. Where a job title is not considered the final definition of who you are, but the starting point.

Education
·  Bachelor's or QE degree in Computer Science, Engineering or related scientific discipline (biomedical engineering, mechanical engineering, electrical engineering) or related biological science field, or equivalent combination of education and work-related experience in the area of software/systems development, verification and validation, required.
·  Master's degree or QE in Computer Science, Engineering or related scientific discipline (biomedical engineering, mechanical engineering, electrical engineering) or related biological science field, or equivalent combination of education and work-related experience in the area of software/systems development, verification and validation, preferred.

Experience
·  Minimum: 3 years: Development and or QA experience of software, instrument systems under design controls and intermediate/advanced knowledge of in vitro diagnostic reagents, instruments and software products including nucleic acid based products related to RMS products and SOPs. Proven interactions with all Quality Management and other departments (Development, GCTA, Regulatory Affairs, and Operations). Strong track record of successful participation on cross functional project teams project teams.
·  Preferred: 5 years: Development and or QA experience of software, instrument systems under design controls and intermediate/advanced knowledge of in vitro diagnostic reagents, instruments and software products including nucleic acid based products related to RMS products and SOPs. Proven interactions with all Quality Management and other departments (Development, GCTA, Regulatory Affairs, and Operations). Strong track record of successful participation on cross functional project teams project teams.
·  Strong working knowledge of QSR/cGMP, Design Controls, Systems/Software Development, Verification and Validation Principles and Practices, ISO 13485, EU IVD Directive, IEC 62304, Agile Development Methodologies.
·