What are the responsibilities and job description for the Quality Manager position at Epredia?
Be a part of a global team where what we do matters! At Epredia, we recognize that our talented employees are vital to our success. Our team is dedicated, our work is rewarding – both personally and professionally – because what we do matters.
We seek talented individuals who will contribute to and thrive in our collaborative, diverse, fast-paced environment while demonstrating a commitment to our core values, People, Customer, Results, Continuous Learning, and Innovation.
People – We win as a team.
Customer – We deliver customer-centric solutions.
Continuous Learning – We learn and always aim to be better.
Innovation – We innovate every day.
Results – Results matter for all of us.
Job Title: Quality Manager
Who you are: You have energy and drive in abundance, a passion for serving our customers and possess a growth mindset and love of continuous learning, with an appreciation for diverse perspectives and helping others win.
Location: This is a Monday-Friday onsite position based out of our Kalamazoo, MI facility.
Position Overview: As the Quality Manager, you will be responsible for providing plant leadership to support and drive the monitoring, measurement, implementation, and continuous improvement of the site's Quality Management System (QMS) following ISO 13485:2016, 21 CFR 820, 210, & 211, and other applicable regulatory guidelines. You will ensure site-wide training and execution of quality systems processes to support both internal and external customers.
What You Will Do
Building an Inclusive Culture: We are a company that brings varying backgrounds, ideas, and points of view to inventing on behalf of all customers. Our diverse perspectives are enriched by many dimensions, including race, ethnicity, gender, age, physical and mental ability, sexual orientation, religious beliefs, culture, language, and education, as well as professional and life experience. We are committed to diversity, equity, and inclusion, and leveraging our unique perspectives to scale our impact and growth.
We seek talented individuals who will contribute to and thrive in our collaborative, diverse, fast-paced environment while demonstrating a commitment to our core values, People, Customer, Results, Continuous Learning, and Innovation.
People – We win as a team.
Customer – We deliver customer-centric solutions.
Continuous Learning – We learn and always aim to be better.
Innovation – We innovate every day.
Results – Results matter for all of us.
Job Title: Quality Manager
Who you are: You have energy and drive in abundance, a passion for serving our customers and possess a growth mindset and love of continuous learning, with an appreciation for diverse perspectives and helping others win.
Location: This is a Monday-Friday onsite position based out of our Kalamazoo, MI facility.
Position Overview: As the Quality Manager, you will be responsible for providing plant leadership to support and drive the monitoring, measurement, implementation, and continuous improvement of the site's Quality Management System (QMS) following ISO 13485:2016, 21 CFR 820, 210, & 211, and other applicable regulatory guidelines. You will ensure site-wide training and execution of quality systems processes to support both internal and external customers.
What You Will Do
- Proactively manage the site quality management system to ensure compliance with applicable quality system regulations
- Act as the Site Quality Management Representative
- Provide leadership and management support to plant quality team (QA & QC)
- Direct and lead quality systems at site to ensure compliance to established requirements and the embracement of a quality culture
- Support the successful implementation of regional and organizational quality initiatives
- Effectively communicate at all levels of the organization
- Bachelor’s degree in a scientific discipline, quality assurance, business, or similar
- 5 years work experience in a regulated environment (ISO 13485, ISO 9001, ISO 15378, or equivalent)
- 5 years of people leadership experience
- Proficient with various business applications (Excel, Word, PowerPoint, Outlook, eQMS, ERP, etc.)
- Certification and experience in auditing quality management systems
- Experience in successfully identifying and leading continuous improvement initiatives
- Experience in the use of statistical and data analysis to drive risk-based decision making
Building an Inclusive Culture: We are a company that brings varying backgrounds, ideas, and points of view to inventing on behalf of all customers. Our diverse perspectives are enriched by many dimensions, including race, ethnicity, gender, age, physical and mental ability, sexual orientation, religious beliefs, culture, language, and education, as well as professional and life experience. We are committed to diversity, equity, and inclusion, and leveraging our unique perspectives to scale our impact and growth.
