Quality Control Inspector II
Job Locations
US-WA-Bothell
ID
2024-17253
Job Function
Quality & Regulatory
Overview
The Quality Control Inspector (QCI) is primarily responsible for Quality Control inspections of all Bruker Spatial Biology incoming raw materials, components and sub-assemblies received at our facilities per inspection plan meeting applicable material specifications. QCI is also responsible for all finished instrumentation testing of all final assembled instruments per inspection plan.
The scope of this position is includes performing all necessary quality control checks, including FAI's and associated reports (First Article Inspection & Reports), using appropriate testing procedures and test instrumentation supported with appropriate documentation for all Bruker Spatial Biology products to manage quality risk and provide oversight over manufacturing processes. This position reports into the Sr. Quality Manager which is part of Quality organization and support associated tasks and activities coordinated and integrated with production and inventory control. The individual ensures consistent implementation, improvement, and compliance to the Bruker Spatial Biology, ISO 13485 and ISO 9001 Quality Management Systems.
Responsibilities
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.
Perform lot validation testing while monitoring and adjusting testing frequencies.
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
Act as Quality ambassador providing decisive approach for implementation to manage Quality Management System with various tasks, projects, as required
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
At least 3 years of experience as a QC inspector in a regulated environment i.e. medical device/ biotechnology/ aerospace industry.
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.
Qualifications<
