Quality Engineer

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.