Quality Assurance Specialist II

Mikron Corporation Denver•Englewood, CO

7h•Hybrid

About The Position

Making complexity accessible At Mikron we are committed to delivering the best assembly systems and all needed services throughout your product’s entire life cycle. With our extensive engineering know-how, complex process expertise, scalable platforms and lifelong support we are driving lasting success for your business. With more than 4,000 assembly and test systems in use worldwide, our team of over 800 qualified employees have unique process expertise and the rigor for complex project management in a wide range of industries. Mikron experts will work closely with you to design an automated assembly system that meets your unique, industry-specific processes, whether for high-volume, medium-volume or lab-scale production. Mikron's standard systems are scalable and customizable to meet your current needs and adapt to future production requirements, without the need for costly and extensive future upgrades.

Requirements

Bachelor of Arts or Bachelor of Science degree
Or 3 to 5 years relevant experience
Thorough understanding of the ISO 9001
Knowledge of ISO 13485 and IS0 45001 regulations
Familiar with Microsoft Office tools
Ability to adapt to priority changes
Ability to communicate in an open, clear, precise, and effective manner with customers, peers, and management
Must have initiative to learn and demonstrate positive behavior toward teamwork
Strong problem solving, analytical, and organizational skills
Strong written and oral communication skills
Certified Quality Auditor
Six Sigma or Green Belt certifications
Must be eligible to work in the United States, have a valid state driver license and be eligible to obtain a passport for international travel
Ability to fluently speak, read and write in English.
Must be able to travel or work flexible hours as required for project deliverables.
Mikron Corporation Denver is a drug free working environment.
Must be able to work on-site at least three days per week at Mikron Automation’s facility. Remote work may be permitted for up to two days per week, subject to project requirements and team alignment.

Responsibilities

Perform internal audits and author internal audit reports
Lead CAPA investigations
Verify effectiveness of CAPA actions
Close Non-Conforming Reports and Engineering Change Control Reports
Participate in customer audits and ISO audits
Perform supplier audits and author supplier audit reports
Provide ISO 9001 orientation training for new hires
Gather and analyze quality metrics and key performance indicators to identify trends and risks
Train employees to processes and procedures
Author customer Quality Agreements
Maintain and develop standard operating procedures to support the Quality Management System
Support and/or Lead Continuous Improvement initiatives
Assist other departments with the creation and revision of controlled procedures
Perform ad hoc duties as needed
Keeps a Customer focus when performing work and communicating both with internal and external customers
Is always striving to better themselves by taking personal responsibility to learn and grow while helping the department adapt and grow while maintaining a positive and professional attitude.
Maintains Customer Confidentiality
Values Teamwork and Collaboration
Leadership
Strengthens Accountability
Builds Effective Teams
Motivates and Develops others
Manages Conflict
Leads with Ethics
Flexible with the ability to remain highly organized while addressing diverse responsibilities and maintaining workload