Senior Quality Engineer (EU-MDR)

Intepros; Mahwah (NJ); On-site; USD 110,000 - 140,000; Full time

Job summary

Intepros in Mahwah, NJ is searching for a Senior Quality Engineer to support EU-MDR compliance initiatives and ensure products and manufacturing processes meet rigorous regulatory standards.

The role leads FAI and PPAP activities, manages change controls, validates equipment and processes, and collaborates with cross-site teams to drive quality improvements and maintain QMS compliance.

Qualifications

• Bachelor's degree in Biomedical or Mechanical Engineering required.
• 4+ years of experience in quality engineering.
• 2+ years supporting EU-MDR programs or regulatory compliance initiatives.
• Strong change control and QMS knowledge.
• Excellent communication and problem-solving skills.

Responsibilities

• Lead First Article Inspection (FAI) activities with strategy, execution, documentation and approvals.
• Support PPAP activities to ensure product and process quality requirements are met.
• Manage change control processes and assess impact on product quality and regulatory compliance.
• Review and update SOPs, risk management documentation, and quality records.
• Support equipment and process validation to ensure compliance with quality standards.
• Identify opportunities for continuous improvement and implement solutions to enhance product quality and manufacturing processes.
• Ensure compliance with regulatory requirements, quality management systems, and internal procedures.
• Collaborate with cross-functional and multi-site teams to resolve quality issues and support regulatory initiatives.

Skills

Quality engineering

Regulatory compliance

Change control

Analytical thinking

Cross-functional collaboration

Education

Bachelor's degree in Biomedical Engineering or Mechanical Engineering

Tools

Microsoft Word

Microsoft Excel

Microsoft PowerPoint

Job description

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.