QA Lab Lead

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. 

We are hiring for a QA Lab Lead to help lead and strengthen our QC and Lab operations. In this role, you’ll partner with the Quality Manager to ensure lab processes are compliant, scalable, and aligned with industry best practices — all while supporting the continued growth of our business. You’ll play a key part in maintaining high quality standards, optimizing lab performance, and empowering the team to focus on strategic initiatives that drive operational excellence.

Location: Onsite - Portsmouth, NH

Skills you will need:

• 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.

Skills you will need:

• Bachelor's Degree or equivalent discipline is preferred.
• 3+ years’ experience in Quality Lab, 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.

TO ALL RECRUITMENT AGENCIES:  Epredia does not accept unsolicited third-party resumes.
 

Building an Inclusive Culture: We are a company that brings the best people together and leverages their varying backgrounds, ideas, and points of view to invent on behalf of all customers. We are committed to equal employment opportunity for all individuals, without regard to race, color, national origin, ancestry, sex, age, religion, physical or mental disability, medical condition, veteran status, marital status, pregnancy, sexual orientation, gender identity, genetic information or any other protected classes which may exist under applicable federal, state or local law.