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: Sr. Quality Engineer 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 an onsite position based out of our Kalamazoo, MI, or Portsmouth, NH facility. Position Overview: As the Senior Quality Engineer (Sr. QE) you will work within the Regional Quality Organization in conjunction with Quality and Site Management to ensure an effective and compliant execution of the overall Quality Management System (QMS). You will be responsible for the implementation, oversight, execution, and reporting of key, assigned systems within the QMS to maintain compliance to ISO 13485:2016 & additional, applicable Regulatory Requirements. Additionally, you will regularly participate in, and may lead, Site and Regional level departmental and cross-functional investigational activities, root cause analysis, and continuous improvement projects. You will have direct supplier and/or customer interactions to support proactive communication and issue handling & resolution. What you will do: + Support and oversee the implementation, execution, reporting, and continuous improvement of assigned Quality System(s), which may include: + Document Control + Change Control + Corrective & Preventive Actions + Complaint Handling + Internal Auditing + Supplier Quality + Product Safety & Compliance + Electronic QMS Development & Administration + Act as the Subject Matter Expert (SME) in assigned Quality Systems + Create and assemble technical documents and/or records supporting the execution of Quality Systems as assigned + Analyze data & trends in Systems, QMS, and plant performance to support the identification and proactive execution of potential issues/risks and/or opportunities for improvement. + Proactively communicates any issues/risks and align on a mutually beneficial plans to address, while ensuring compliance to ISO 13485:2016 & additional, applicable Regulatory Requirements. + Assist Plant and Regional Teams, as required, with investigations, root cause analyses, and the implementation of corrections, corrective actions, and preventive actions. + Participate in Plant and Regional projects, as assigned, acting as the Quality liaison and SME + Has direct supplier or customer interactions including, where assigned, on-site audits & interactions + May have up to 10% travel + May have 1-2 direct reports Qualifications & Skills: + Bachelor’s Degree and 5 years’ experience required + Experience working within an ISO environment (ISO 13485, 9001, 15378, 22000, etc.) + Experience working with in a regulated environment (FDA, IVDR, etc.) + Auditor certification strongly preferred + Strong experience in root cause analysis and continuous improvement + Experience with system development and project management + Strong technical writing skills + Must be able to lift up to 40 lbs #LI-KW1 TO ALL RECRUITMENT AGENCIES: Epredia does not accept unsolicited third-party resumes. 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. At Epredia, we improve lives by enabling better cancer diagnostics. We are a team of talented individuals with diverse backgrounds and expertise, working together to develop precision diagnostic solutions for our customers. We are a fast growing global company that drives innovation in diagnostics to create better outcomes for patients. Joining Epredia is much more than a job- it is an opportunity to be part of something with a purpose. Find out how you can improve lives while advancing your career.