Senior Engineer/Scientist PMQ

Roche • Indianapolis, IN

17d • Onsite

About The Position

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. 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.

Requirements

• 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.

Responsibilities

• support the CoreLab Network in handling complaints within mass spectrometry and are a specialist for the hardware of the Cobas i 601
• 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
• 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
• 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
• 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
• contribute to the creation of regular reports to document product quality and performance in the market
• work autonomously and with minimal supervision
• support knowledge transfer for new products to ensure comprehensive system knowledge is available
• involved in the induction and mentoring of new team members

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 1,001-5,000 employees