Senior Engineer/Scientist PMQ Full-time

Senior Engineer/Scientist PMQ

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

You will be part of a dynamic team in Post-Market Quality (PMQ). We are the experts who ensure that our products are of the highest quality. Our daily work is characterized by meticulous detail, technical expertise, and close collaboration with internal and external stakeholders, such as our global and local Roche functions. We support each other, share our knowledge, and act as coaches for new team members. Your expertise is needed here to solve complex cases and continuously improve our processes so that we can meet the needs of our customers and patients even better.

The Opportunity

• As a Senior Engineer/Scientist PMQ, you support the CoreLab Network in handling complaints within mass spectrometry and are a specialist for the hardware of the Cobas i 601.
• You are responsible for the timely and independent processing of customer complaints and inquiries from the market (including potentially reportable and safety-relevant issues) in accordance with the requirements of applicable ISO standards, regulations, and our internal Roche mQMS. This includes acceptance, classification, investigation, and resolution of cases and their complete documentation.
• You are in contact with country organizations to get a full picture of the problems in the market and to promptly communicate new quality information in the form of “Notifications” to them. You also work closely with global and/or local functions (e.g., R&D, Operations, CDMA) and are responsible for ensuring that appropriate measures are derived from the cases in a timely manner.
• You analyze data using statistical methods to identify potential product problems, are responsible for a complete risk assessment, and initiate Corrective and Preventive Actions (CAPAs) and/or non-conformities from complaints. You also contribute to the creation of regular reports to document product quality and performance in the market.
• You work autonomously and with minimal supervision. Additionally, you support knowledge transfer for new products to ensure comprehensive system knowledge is available. You are also involved in the induction and mentoring of new team members.

Who You Are

• You are an experienced expert in the world of diagnostics or a comparable environment
• You have a Bachelors or Masters Degree in medical technology, electrical engineering, biotechnology, chemistry, or related field.
• You have experience with and knowledge of mass spectrometry.
• You have 3+ years of professional experience in a technical product support position (5+ years preferred), in research and development, in technical customer support, in product complaint handling, or in a similar function.
• You have sound GMP knowledge and/or knowledge of regulatory requirements.
• You hold a high degree of problem-solving action. Communication skills, teamwork ability, and strong customer orientation characterize you.
• Business-fluent English skills, both written and spoken, are essential for this role.

Location

This is a primarily on-site position in Indianapolis. This position may require minimal domestic and international travel on an as needed basis. Relocation benefits are not available for this position. The expected salary range for this position based on the primary location of Indianapolis is $62,370 and $135,370. 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.

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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