Make an Impact in Quality & Innovation
We are seeking a Quality Engineer to play a critical role in ensuring our products meet the highest standards of quality, reliability, and regulatory compliance. This position is a key technical resource, bridging engineering, manufacturing, and quality systems to support the delivery of high-performing medical products.If you are a detail-oriented problem solver with a passion for process improvement, risk mitigation, and regulatory excellence, this is an opportunity to contribute to meaningful, high-impact work.
What You’ll Do
In this role, you will actively ensure that products, processes, and systems meet corporate, industry, and regulatory standards while driving continuous improvement.
Key Responsibilities
- Ensure compliance with ISO 13485 and FDA quality system regulations
- Evaluate design and process changes for impact to Design History Files (DHF) and lead gap closure activities
- Develop and implement manufacturing control plans and supplier quality oversight
- Lead component qualification activities (first articles, capability studies, Gage R&R, SPC)
- Develop and validate inspection and test methods using advanced measurement tools (CMM, vision systems, micrometers, calipers)
- Conduct risk assessments (DFMEA / PFMEA) and support risk management initiatives
- Perform internal audits and participate in customer/regulatory audits
- Support CAPA investigations, nonconforming material processes, and root cause analysis
- Lead or support process validation and equipment qualification
- Drive continuous improvement initiatives across manufacturing and quality systems
- Support product transfers and design reviews, ensuring manufacturability and compliance
What You Bring
We are looking for a candidate who combines technical expertise, regulatory knowledge, and strong collaboration skills.
Required Qualifications
- Bachelor’s degree in Engineering or a related field
- Minimum 3 years of experience in an ISO-certified and/or FDA-regulated manufacturing environment
- Strong understanding of:
- Quality systems and methodologies
- FDA GMP and CAPA processes
- Statistical techniques and process control tools
Preferred Qualifications
- Certified Quality Engineer (CQE) or equivalent
- Experience with GD&T (Geometric Dimensioning & Tolerancing)
- Background in design control and product development environments
Core Competencies
- High level of accountability and self-motivation
- Strong analytical and problem-solving skills
- Effective communication and cross-functional collaboration
- Ability to interpret technical documentation and present findings clearly
Why Join Us
- Be part of a high-impact quality team supporting regulated products
- Work in a collaborative environment focused on continuous improvement and innovation
- Opportunity to influence product quality, safety, and regulatory compliance
Work Environment
This role operates in a professional engineering and manufacturing setting with a moderate noise level. Occasional standing, walking, and interaction with production areas are required.
