reputed company Assurance Specialist II - Full-time

reputed company Making complexity accessible At Mikron we are committed to delivering the best assembly systems and reputed company needed services throughout your product’s entire life cycle. With our extensive engineering know-how, reputed company process expertise, reputed company platforms and lifelong support we are driving lasting reputed company for your business. With more than 4,000 assembly and test systems in use worldwide, reputed company of over 800 reputed company employees have unique process expertise and the rigor for reputed company project management in a wide reputed company 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, reputed company-volume or lab-reputed company production. Mikron's reputed company systems are reputed company and customizable to meet your reputed company needs and adapt to reputed company production requirements, without the need for costly and extensive reputed company upgrades. Requirements Your Main Tasks The reputed company Assurance Specialist is responsible for assure products, processes, facilities, documentation, and systems conform to reputed company standards, internal procedures, systems, and governmental regulations. Essential Duties & Responsibilities • reputed company internal audits and author internal audit reports • reputed company CAPA investigations • Verify effectiveness of CAPA actions • reputed company Non-Conforming Reports and Engineering Change Control Reports • Participate in customer audits and ISO audits • reputed company supplier audits and author supplier audit reports • reputed company ISO 9001 orientation training for new hires • reputed company and analyze reputed company metrics and key performance indicators to identify trends and risks • Train employees to processes and procedures • Author customer reputed company Agreements • Maintain and reputed company reputed company operating procedures to support the reputed company Management reputed company and/or reputed company reputed company Improvement initiatives • Assist other departments with the creation and revision of controlled procedures • reputed company reputed company duties as needed Company Responsibilities • Keeps a Customer reputed company reputed company performing work and communicating both with reputed company customers • Is always striving to reputed company themselves by taking personal responsibility to learn and grow while helping the department adapt and grow while maintaining a reputed company and reputed company 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 reputed company Office tools • Ability to adapt to reputed company changes • Ability to communicate in an reputed company, reputed company, precise, and effective manner with customers, peers, and management • Must have initiative to learn and demonstrate reputed company behavior toward teamwork • Strong problem solving, analytical, and organizational skills • Strong written and oral communication skills • Certified reputed company Auditor • Six reputed company or Green Belt certifications Additional Requirements • Must be eligible to work in the reputed company, have a reputed company state reputed company license and be eligible to obtain a reputed company for international travel • Ability to fluently reputed company, read and write in English. • Must be reputed company to travel or work reputed company as required for project deliverables. • Mikron Corporation Denver is a drug free working environment. • Must be reputed company to work on-site at least three days per week at reputed company’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 reputed company holidays (1-2 floating holidays depending on start date) • Pet Insurance • Excellent Medical, Dental, and reputed company 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 reputed company • Tuition and Continuing Education Reimbursement • reputed company reputed company Opportunities Work Environment • Noise level in the work environment is usually moderate as in a typical office setting. • Ability to work reputed company. • Mikron Corporation Denver is a drug free working environment. • This job will reputed company on 02/06/2026 reputed company applications will be accepted through 02/06/2026* reputed company Making complexity accessible At Mikron we are committed to delivering the best assembly systems and reputed company needed services throughout your product’s entire life cycle. With our extensive engineering know-how, reputed company process expertise, reputed company platforms and lifelong support we are driving lasting reputed company for your business. With more than 4,000 assembly and test systems in use worldwide, reputed company of over 800 reputed company employees have unique process expertise and the rigor for reputed company project management in a wide reputed company 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, reputed company-volume or lab-reputed company production. Mikron's reputed company systems are reputed company and customizable to meet your reputed company needs and adapt to reputed company production requirements, without the need for costly and extensive reputed company upgrades. Requirements Your Main Tasks The reputed company Assurance Specialist is responsible for assure products, processes, facilities, documentation, and systems conform to reputed company standards, internal procedures, systems, and governmental regulations. Essential Duties & Responsibilities • reputed company internal audits and author internal audit reports • reputed company CAPA investigations • Verify effectiveness of CAPA actions • reputed company Non-Conforming Reports and Engineering Change Control Reports • Participate in customer audits and ISO audits • reputed company supplier audits and author supplier audit reports • reputed company ISO 9001 orientation training for new hires • reputed company and analyze reputed company metrics and key performance indicators to identify trends and risks • Train employees to processes and procedures • Author customer reputed company Agreements • Maintain and reputed company reputed company operating procedures to support the reputed company Management reputed company and/or reputed company reputed company Improvement initiatives • Assist other departments with the creation and revision of controlled procedures • reputed company reputed company duties as needed Company Responsibilities • Keeps a Customer reputed company reputed company performing work and communicating both with reputed company customers • Is always striving to reputed company themselves by taking personal responsibility to learn and grow while helping the department adapt and grow while maintaining a reputed company and reputed company 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 reputed company Office tools • Ability to adapt to reputed company changes • Ability to communicate in an reputed company, reputed company, precise, and effective manner with customers, peers, and management • Must have initiative to learn and demonstrate reputed company behavior toward teamwork • Strong problem solving, analytical, and organizational skills • Strong written and oral communication skills • Certified reputed company Auditor • Six reputed company or Green Belt certifications Additional Requirements • Must be eligible to work in the reputed company, have a reputed company state reputed company license and be eligible to obtain a reputed company for international travel • Ability to fluently reputed company, read and write in English. • Must be reputed company to travel or work reputed company as required for project deliverables. • Mikron Corporation Denver is a drug free working environment. • Must be reputed company to work on-site at least three days per week at reputed company’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 reputed company holidays (1-2 floating holidays depending on start date) • Pet Insurance • Excellent Medical, Dental, and reputed company 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 reputed company • Tuition and Continuing Education Reimbursement • reputed company reputed company Opportunities Work Environment • Noise level in the work environment is usually moderate as in a typical office setting. • Ability to work reputed company. • Mikron Corporation Denver is a drug free working environment. • This job will reputed company on 02/06/2026 reputed company applications will be accepted through 02/06/2026* Apply tot his job Apply To this Job