QC Inspector

About the role

Bruker Nano, one of Bruker’s four operating segments, provides customers in academic and governmental institutions, life science, materials, and applied industries with the tools to determine the characteristics of matter and visualize the structure of molecules.

Responsibilities

• Perform timely incoming and final quality control inspections to support Manufacturing and Operations quality for all Bruker Spatial Biology instruments following approved and active Incoming Specifications
• Update incoming inspection specifications and procedures as required, in collaboration with other cross-functional departments
• Record non conformances and support in conducting root cause investigations
• Manage nonconforming (or potentially nonconforming) material through disposition
• Support review and updating of SOPs relating to Quality Control Procedures
• Collaborate with Manufacturing, Manufacturing Engineering, New Product Introduction, Procurement, Quality, and Supply Chain partners as well as vendors on the above activities
• Basic application of statistical tools and methods
• Participates in FDA/ISO inspections and customer audits and maintain ongoing audit readiness
• Perform other relevant duties as may be assigned by management

Skills And Abilities

• Analytical decision-making skills to apply logical or Quality control thinking principles to operations using pragmatic approaches
• Demonstrates working knowledge of ISO 9001, ISO 13485 quality system and/or FDA 21 CFR 820 quality regulations as applicable to products
• Analytical and creative problem-solving skills that include experience in leading and or participating on process improvement/lean projects
• Excellent written and oral communication skills
• Ability to work independently and collaboratively in cross-functional teams
• Ability to multi-task with demonstrated problem solving skills in a fast paced complex environment

Specialized Knowledge

• GD&T and CMM skills is preferred

Qualifications

• Minimum Education: Bachelor’s degree in a related field strongly preferred OR High school STEM or technical diploma or equivalent BS in technical discipline, real world hands-on regulated industry experience may also be considered
• Minimum Experience : 3-5 years quality-related experience in biotech, the pharmaceutical or consumer regulated device industry