Quality Engineer

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.

In this role you will actively ensure that products processes and systems meet corporate industry and regulatory standards while driving continuous improvement.

• 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

We are looking for a candidate who combines technical expertise regulatory knowledge and strong collaboration skills.

• Bachelors 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

• Certified Quality Engineer (CQE) or equivalent
• Experience with GD&T (Geometric Dimensioning & Tolerancing)
• Background in design control and product development environments

• 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

• 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

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.