Senior Quality Engineer (EU-MDR)

Senior Quality Engineer - EU-MDR | Medical Device

Location: Mahwah, NJ (Onsite)

We are seeking an experienced Senior Quality Engineer to support a leading global medical device company in Mahwah, NJ. This individual will play a key role in supporting European Union Medical Device Regulation (EU-MDR) compliance initiatives, ensuring products and manufacturing processes meet rigorous quality and regulatory standards.

The ideal candidate will bring a strong background in quality engineering, regulatory compliance, and manufacturing processes, with hands-on experience supporting EU-MDR initiatives. This position offers the opportunity to collaborate with cross-functional teams across multiple sites while driving quality improvements, managing change controls, and supporting product compliance.

Key Responsibilities

• Lead First Article Inspection (FAI) activities, including strategy development, execution, documentation, and approvals.
• Support Production Part Approval Process (PPAP) activities to ensure product and process quality requirements are met.
• Manage change control processes, including evaluating and documenting the impact of proposed changes on product quality and regulatory compliance.
• Review and update Standard Operating Procedures (SOPs), risk management documentation, and quality records.
• Support equipment and process validation activities to ensure compliance with established quality standards.
• Identify opportunities for continuous improvement and implement solutions to enhance product quality and manufacturing processes.
• Ensure compliance with applicable regulatory requirements, quality management systems, and internal procedures.
• Serve as a key Quality Engineering representative, collaborating with cross-functional and multi-site teams to resolve quality issues and support regulatory initiatives.

Required Qualifications

• Bachelor's degree in Biomedical Engineering, Mechanical Engineering, or a related engineering discipline.
• Minimum of 4 years of professional experience in quality engineering.
• At least 2 years of experience supporting EU-MDR programs or regulatory compliance initiatives .
• Strong understanding of change control, change impact assessments, and Quality Management Systems (QMS).
• Demonstrated ability to independently evaluate technical issues, troubleshoot problems, and make sound engineering decisions.
• Strong analytical, organizational, and problem-solving skills with excellent attention to detail.
• Excellent written and verbal communication skills with the ability to collaborate across multiple teams.
• Proficiency in Microsoft Word, Excel, and PowerPoint.
• Ability to manage competing priorities in a fast-paced, regulated environment.

Preferred Qualifications

• Previous experience within the medical device industry.
• Familiarity with ISO 13485, European medical device regulations, Good Documentation Practices (GDP), and Good Manufacturing Practices (GMP).
• Knowledge of risk-based quality methodologies and statistical analysis techniques.