Job Description

Our client is seeking a Senior Quality Engineer to join their team and drive excellence in quality and compliance for class I-II medical devices. This role requires a strong background in global medical device regulations, including EU MDR and FDA requirements.

Key Responsibilities:

• Ensure compliance with EU MDR, FDA 21 CFR Part 820, ISO 13485, and other global regulations.
• Lead quality system improvements, including CAPA, audits, and process validation.
• Provide regulatory guidance on design controls, risk management, and post-market surveillance.
• Collaborate with cross-functional teams to ensure regulatory and quality compliance in product development and manufacturing.
• Support internal and external audits, including FDA and notified body inspections.

Qualifications:

• Bachelor’s degree in Engineering, Quality, or related field.
• 5+ years of experience in medical device quality engineering.
• Strong knowledge of EU MDR, FDA regulations, and ISO 13485.
• Experience with sterilization preferred.
• Experience with risk management (ISO 14971), CAPA, and validation processes.
• Excellent problem-solving and communication skills.

On Offer:

• Onsite training and career progression - great chance for someone with management aspirations.
• Competitive salary, bonus, and benefits.
• Relocation bonus (if applicable).

This is a great opportunity to make a direct impact on patient safety and regulatory compliance in a growing, innovative medical device company.

Job Tags

Similar Jobs