F. Hoffmann-La Roche Gruppe
Senior Engineer PMQ
F. Hoffmann-La Roche Gruppe, Indianapolis, Indiana, us, 46262
Roche fosters diversity, equity and inclusion, representing the communities we serve. When dealing with healthcare on a global scale, diversity is an essential ingredient to success. We believe that inclusion is key to understanding people’s varied healthcare needs. Together, we embrace individuality and share a passion for exceptional care. Join Roche, where every voice matters.The Position
We are looking for a Senior Engineer to support the Case Handling and Affiliate Support Chapter within Post-Market Quality (PMQ) for the Roche Near Patient Care Lab portfolio.As a Senior Engineer in PMQ, you will act as an escalation point for non-routine product complaints. This role will develop and update company complaint and inspection procedures to ensure the capture and investigation of complaints. A Senior Engineer maintains and analyzes problem logs to identify and report recurring issues to quality assurance management and product development. This position will document and track contact information, report issues and problems in accordance with company guidelines and external regulatory requirements, and may collaborate with other internal groups to respond to product inquiries and issues.The Opportunity
Accountable for timely handling and resolution of individual cases (inquiries, complaints, potential reportable and safety issues) per ISO Quality System requirements.
Conduct investigations, experimental design, and data analysis to resolve cases, potentially consulting senior team members.
Ensure comprehensive risk assessments for product quality issues and timely communication of quality-related information to relevant organizations.
Collaborate with global/local functions to derive appropriate measures from cases, including workarounds, and support product teams with case information for documentation updates.
Participate in on-boarding and mentoring new employees, contributing to knowledge transfer for new products from project phases.
Create and approve notifications and ensure efficient laboratory organization and compliance with laboratory policies, including equipment inspections and documentation.
Support audits, inspections, regular reporting, quality reviews, and CAPA tasks to enhance on-market product quality, performance, and process optimization.
Contribute to cross-team meetings and projects, provide guidance to less experienced colleagues, and potentially act as a proxy for the Principal role.
Perform additional duties as assigned to meet PMQ goals and objectives, ensuring continuous improvement, compliance, and customer satisfaction.
Permanently optimizes processes in order to increase quality and efficiency standards.
Who you are
You have a Bachelors in life sciences, engineering or related fields required.
You have an advanced degree in Electrical Engineering, Microbiology, Genomics, NextGen Sequencing, Chemistry, Bioinformatics or related sciences is preferred.
You have 3 years of work experience in a technical product support role, research and development setting, technical customer support role, product complaint handling or related function.
You are proficient in technical writing.
Proficiency in English, with strong communication and intercultural skills, working autonomously with minimal supervision.
Preferred Knowledge, Skills and Abilities
Hands-on experience and expertise in Hardware and Electrical Engineering is preferred.
Industry experience with Customer Support, field technical support, and face to face customer support and training. Related core laboratory field technical support may also be considered.
Demonstrate solid critical thinking and problem solving skills with a positive and creative attitude and approach.
Demonstrate collaborative mind-set and ability to manage and foster stakeholder relationships and expectations.
Demonstrate good laboratory practices.
Demonstrate good communication skills: verbal, writing, presentation, technical writing.
Relocation assistance is not available for this position.The expected salary range for this position based on the primary location of Indianapolis is 62,400.00 - 115,800.00 USD Annual. 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.Who we are
At Roche, more than 100,000 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.As a global leader in healthcare, Roche Diagnostics offers a broad portfolio of products, tools and services that help in the prevention, diagnosis and management of diseases like HPV, HIV, hepatitis and diabetes as well as other medical conditions, such as fertility and blood coagulation. These products and services are used by researchers, physicians, patients, hospitals and laboratories worldwide to help improve people's lives.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 relation to the online application process, please contact us by completing this form.
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We are looking for a Senior Engineer to support the Case Handling and Affiliate Support Chapter within Post-Market Quality (PMQ) for the Roche Near Patient Care Lab portfolio.As a Senior Engineer in PMQ, you will act as an escalation point for non-routine product complaints. This role will develop and update company complaint and inspection procedures to ensure the capture and investigation of complaints. A Senior Engineer maintains and analyzes problem logs to identify and report recurring issues to quality assurance management and product development. This position will document and track contact information, report issues and problems in accordance with company guidelines and external regulatory requirements, and may collaborate with other internal groups to respond to product inquiries and issues.The Opportunity
Accountable for timely handling and resolution of individual cases (inquiries, complaints, potential reportable and safety issues) per ISO Quality System requirements.
Conduct investigations, experimental design, and data analysis to resolve cases, potentially consulting senior team members.
Ensure comprehensive risk assessments for product quality issues and timely communication of quality-related information to relevant organizations.
Collaborate with global/local functions to derive appropriate measures from cases, including workarounds, and support product teams with case information for documentation updates.
Participate in on-boarding and mentoring new employees, contributing to knowledge transfer for new products from project phases.
Create and approve notifications and ensure efficient laboratory organization and compliance with laboratory policies, including equipment inspections and documentation.
Support audits, inspections, regular reporting, quality reviews, and CAPA tasks to enhance on-market product quality, performance, and process optimization.
Contribute to cross-team meetings and projects, provide guidance to less experienced colleagues, and potentially act as a proxy for the Principal role.
Perform additional duties as assigned to meet PMQ goals and objectives, ensuring continuous improvement, compliance, and customer satisfaction.
Permanently optimizes processes in order to increase quality and efficiency standards.
Who you are
You have a Bachelors in life sciences, engineering or related fields required.
You have an advanced degree in Electrical Engineering, Microbiology, Genomics, NextGen Sequencing, Chemistry, Bioinformatics or related sciences is preferred.
You have 3 years of work experience in a technical product support role, research and development setting, technical customer support role, product complaint handling or related function.
You are proficient in technical writing.
Proficiency in English, with strong communication and intercultural skills, working autonomously with minimal supervision.
Preferred Knowledge, Skills and Abilities
Hands-on experience and expertise in Hardware and Electrical Engineering is preferred.
Industry experience with Customer Support, field technical support, and face to face customer support and training. Related core laboratory field technical support may also be considered.
Demonstrate solid critical thinking and problem solving skills with a positive and creative attitude and approach.
Demonstrate collaborative mind-set and ability to manage and foster stakeholder relationships and expectations.
Demonstrate good laboratory practices.
Demonstrate good communication skills: verbal, writing, presentation, technical writing.
Relocation assistance is not available for this position.The expected salary range for this position based on the primary location of Indianapolis is 62,400.00 - 115,800.00 USD Annual. 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.Who we are
At Roche, more than 100,000 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.As a global leader in healthcare, Roche Diagnostics offers a broad portfolio of products, tools and services that help in the prevention, diagnosis and management of diseases like HPV, HIV, hepatitis and diabetes as well as other medical conditions, such as fertility and blood coagulation. These products and services are used by researchers, physicians, patients, hospitals and laboratories worldwide to help improve people's lives.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 relation to the online application process, please contact us by completing this form.
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