Quality Assurance Specialist II at Mikron Holding AG

Englewood, Colorado, United States -

Full Time

Start Date

Immediate

Expiry Date

10 Apr, 26

Salary

0.0

Posted On

10 Jan, 26

Experience

2 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Quality Assurance, ISO 9001, ISO 13485, ISO 45001, Internal Audits, CAPA Investigations, Quality Metrics, Training, Problem Solving, Analytical Skills, Organizational Skills, Communication Skills, Teamwork, Continuous Improvement, Microsoft Office, Six Sigma

Industry

Automation Machinery Manufacturing

Description

Description 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 Your Main Tasks The Quality Assurance Specialist is responsible for assure products, processes, facilities, documentation, and systems conform to quality standards, internal procedures, systems, and governmental regulations. Essential Duties & 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 Company Responsibilities 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 Strong attention to detail Flexible with the ability to remain highly organized while addressing diverse responsibilities and maintaining workload Required Education, Experience, Knowledge, & Skills 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 Additional Requirements 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. Company Offered Benefits PTO 10 paid holidays (1-2 floating holidays depending on start date) Pet Insurance Excellent Medical, Dental, and Vision insurance Short Term Disability, Long Term Disability, Life Insurance & ADD FSA, HSA Eligible for Over Time Employee Assistance Program 401k with matching up to 5%, immediately vested Tuition and Continuing Education Reimbursement Professional Growth Opportunities Work Environment Noise level in the work environment is usually moderate as in a typical office setting. Ability to work flexible hours. Mikron Corporation Denver is a drug free working environment. *This job will close on 02/06/2026 all applications will be accepted through 02/06/2026*

Responsibilities

The Quality Assurance Specialist is responsible for ensuring that products, processes, and systems conform to quality standards and regulations. This includes performing audits, leading investigations, and maintaining quality documentation.