QC Inspector

UNAVAILABLE; Bothell (WA); On-site; USD 41,500 - 66,000; Full time

Benefits offered by this job

401(k) with company match

Employee stock purchase plan

Medical and dental plans

Life insurance

Paid time off including vacation

Job summary

Bruker in Bothell, WA is seeking a Quality Control Inspector responsible for quality control inspections of incoming materials and finished instruments. Candidates must have 3-5 years of relevant experience in biotech or the regulated device industry.

The satisfactory candidate will perform quality checks and manage documentation to ensure compliance with ISO standards, contributing to safety and quality within the production process.

Qualifications

• 3-5 years quality-related experience in biotech or regulated device industry.
• Experience as a QC inspector in a regulated environment.
• Hands-on regulated industry experience may also be considered.

Responsibilities

• Perform incoming and final quality control inspections.
• Record non-conformances and manage material disposition.
• Ensure compliance with ISO 13485 and ISO 9001 quality systems.

Skills

Analytical decision-making

Knowledge of ISO 9001

Problem-solving skills

Excellent communication skills

Ability to multi-task

Education

Bachelor’s degree in a related field

High school STEM or technical diploma

Tools

GD&T

CMM

Job description

Overview

As one of the world’s leading analytical instrumentation companies, Bruker covers a broad spectrum of advanced solutions in all fields of research and development. All our systems and instruments are designed to improve safety of products, to accelerate time-to-market, and to support industries in successfully enhancing quality of life. We have been driving innovation in analytical instrumentation for over 60 years now. Today, more than 8,500 employees distributed across 90 locations around the world continue to delight our customers with innovative solutions.

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. Divisions within BNANO include Bruker AXS, Bruker Nano Analytics, Bruker Nano Surfaces and Metrology, Fluorescence Microscopy, and Canopy.

The Quality Control Inspector (QCII) 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. QCII is also responsible for all finished instrumentation testing of all final assembled instruments per inspection plan.

Responsibilities

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.

• 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 3years of experience as a QC inspector in a regulated environment i.e. medical device/ biotechnology/ aerospace industry.

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.

At Bruker, base salary is part of our total compensation. The estimated base salary range for this full-time position is between $41,500 and $66,000 provides an opportunity to progress as you grow and develop within a role. The base salary for the role will depend on a several job-related factors, including, but not limited to education, training, experience, the geographic location of the successful candidate, skills, competencies, job-related knowledge and travel requirements for this position. Full-time employees may also be eligible for a performance-related incentive in addition to a full range of benefits including 401(k) with company match, an employee stock purchase plan, medical and dental plans, life insurance, short-term and long-term disability insurance, employee assistance program and paid time off including vacation, sick time and holidays, and more.

Bruker is an equal-opportunity employer. We evaluate qualified applicants without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, and other legally protected characteristics.

Certain positions at Bruker require compliance with export control laws and as a result, all interviewed candidates for all positions will be screened pre-interview to determine their eligibility in light of export control restrictions.