Senior Engineer PMQ

Roche - Annapolis, IN

Full-time - Mid Level

Annapolis, IN

10,001+ employees

Chemical Manufacturing

About the position

The Senior Engineer in Post-Market Quality (PMQ) at Roche is responsible for supporting the Case Handling and Affiliate Support Chapter within the Roche Near Patient Care Lab portfolio. This role involves acting as an escalation point for non-routine product complaints, developing and updating complaint and inspection procedures, and maintaining problem logs to identify recurring issues. The Senior Engineer will ensure compliance with ISO Quality System requirements, conduct investigations, and collaborate with various teams to enhance product quality and customer satisfaction.

Responsibilities

• Act as an escalation point for non-routine product complaints.
• Develop and update company complaint and inspection procedures.
• Maintain and analyze problem logs to identify recurring issues.
• Document and track contact information and report issues in accordance with company guidelines and regulatory requirements.
• Conduct investigations, experimental design, and data analysis to resolve cases.
• Ensure comprehensive risk assessments for product quality issues and timely communication of quality-related information.
• Collaborate with global/local functions to derive appropriate measures from cases.
• Participate in onboarding and mentoring new employees.
• Create and approve notifications and ensure compliance with laboratory policies.
• Support audits, inspections, regular reporting, quality reviews, and CAPA tasks.
• Contribute to cross-team meetings and projects, providing guidance to less experienced colleagues.
• Optimize processes to increase quality and efficiency standards.

Requirements

• Bachelor's degree in life sciences, pathology, engineering, or related fields required.
• Advanced degree in Electrical Engineering, Microbiology, Genomics, NextGen Sequencing, Chemistry, Bioinformatics, or related sciences preferred.
• 3 years of work experience in a technical product support role, research and development setting, or product complaint handling.
• Proficient in technical writing and communication in English.

Nice-to-haves

• Hands-on experience and expertise in Hardware and Electrical Engineering.
• Industry experience with Customer Support and field technical support.
• Solid critical thinking and problem-solving skills.
• Collaborative mindset and ability to manage stakeholder relationships.
• Good laboratory practices and communication skills.

Benefits

• Discretionary annual bonus based on individual and company performance.