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.
About the opportunity:
As the Quality Assurance Engineer, you will lead the implementation of assurances, process controls, and Corrective and Preventive Action activities designed to meet or exceed internal and external requirements. You will act as an effective leader and team member in supporting quality disciplines, decisions, and practices and will apply sound, systematic, problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues. You will develop, refine, and document QA Test and Inspection procedures, select and order equipment as required, and evaluate and recommend QA sampling plans based on desired confidence limits, process capabilities, and manufacturing/inspection methods and equipment.
Location: This is an onsite position based out of our Portsmouth, NH manufacturing facility
What you will be doing:
Lead quality-related activities and ensure Quality Management System (QMS) compliance. Assess quality systems and overall manufacturing capabilities. Assist in defining technical requirements for inspection activities and criteria, including gauging and tooling, measurement systems, and records Engineering and Incoming Inspection. Troubleshooting process issues. Interface with in-house and outside sub-contract suppliers on quality issues.Drive corrective actions to eliminate recurring supplied product deficiencies. Manage the process for timely review, disposition, and communication of root cause fix.Supports risk analysis (Failure Mode and Effects Analysis) activities.Work in team environment with Manufacturing, R&D, Purchasing and suppliers to improve quality while reducing material scrap and cost.Develop and administer technical investigation and corrective action programs to resolve recurring quality problems.21 CFR Part 820 complaint handling and reporting.CAPA and MRB processes for nonconforming products.Write standard operating procedures and work instructions in support of the QMS.Participate in verification/validation activities (process, sterilization, software) and have an understanding of general requirements associated with this process.What you need for success
Bachelor's Degree in Engineering or equivalent discipline is preferred.3+ years’ experience in Quality Engineering, preferably in an FDA-registered medical device facility. ASQ certification is a plus.Experience with internal auditing of an ISO 13485:2016 (or ISO 9001) Quality Management System. Lead auditor experience a plus.Strong working knowledge of quality-related tools, such as structured problem solving, FMEA’s, SPC, and DOE’s.Ability to analyze technical information and provide recommendations. Able to coordinate multiple projects supporting customer satisfaction, production efficiency, and supplied product issues resolution.Working knowledge of computer software such as Excel or Mini-tab.Ability to travel to supplier sites if necessary.#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.