Roche Molecular, one of four customer-focused areas of Roche Diagnostics Solutions, develops, manufactures and supplies a wide array of innovative molecular diagnostic products, tests, platforms and technologies used to identify and quantify DNA and RNA from different organisms. We are transforming testing and treatment together. As pioneers of polymerase chain reaction (PCR) technology, scientific and clinical excellence is in our DNA. Our leadership and continued advancement of the technique enables PCR to make real differences in the lives of patients, laboratories and healthcare professionals everywhere.
Make a Big Difference
As a Design Quality Engineer, you will provide support and guidance to product development teams on Design Control, Compliance to Regulations, Product Launch, etc., while improving Quality Systems/Processes.
Provide Design Control guidance to product development under direction from Life Cycle Teams (LCT).
Act as the single point representative for all Quality Management activities for Project Teams.
Review and approve documentation consistent with design control regulations, guidance, RMS policy and SOPs.
Documentation to include but not limited to DHF documents such as customer requirements, product requirements, design and development plans and reports, non-clinical protocols and reports, design transfer documents, labeling, clinical plan and reports, 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.
Participate in difficult discussions, challenge the status quo, and identify mutually beneficial compliant solutions/compromises with cross functional colleagues at the Project Team level. Work closely and partner with DQA colleagues within and across sites with the goal of DQA alignment.
Author Quality Reports. Advise and support project teams during the planning of milestones. Assist management in assessment of whether the project has met requirements to pass milestone.
Provide feedback on new or revised SOP’s governing or associated with design control activities/compliance.
May be the key contributor/coordinator for Quality feedback on SOP revisions working closely with the respective SOP owner and DQA leadership.
Support internal and external audits/inspections.
May Proxy for QFL as requested for LCT.
Activities may include nonconformance review and approval, and document change review and approval within Trackwise. Activities may include equipment installation qualification review and approval.
Bachelor’s degree in Chemistry, Biochemistry, Molecular Biology or related scientific discipline or equivalent combination of education and work-related experience. Master’s degree is preferred.
A minimum of 5+ years of experience under established quality regulations, including intermediate knowledge of medical device or pharma processes; 8+ years of experience working under established quality regulations with knowledge of in-vitro diagnostic products including nucleic acid based products is preferred.
Strong track record of successful participation on cross-functional teams.
Working knowledge of QSR/cGMP, ISO and Design Controls.
Excellent oral, written and interpersonal communication skills.
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 US.Accommodation@roche.com.
Internal Number: 202103-107463
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