Senior Quality Engineer - MedDevice Validation & Compliance

GForce Life Sciences; Mahwah (NJ); On-site; USD 110,000 - 140,000; Full time

Job summary

GForce Life Sciences is seeking a Senior Quality Engineer to support quality assurance, control, and preventative activities within operations for a medical device environment in New Jersey. The role emphasizes FAI strategy, PPAP, change control, risk management, and validation activities, with collaboration across sites and cross-functional teams.

Requires EU-MDR experience, strong engineering/quality concepts, and the ability to travel up to 10%.

Qualifications

• Bachelor’s Degree in Biomedical Engineering, Mechanical Engineering, or related field.
• 4+ years of relevant industry experience.
• Experience supporting EU-MDR programs.
• Knowledge of Change Management and Quality Management Systems (QMS) principles.
• Good understanding of engineering and quality concepts.
• Proficiency with Microsoft Word, Excel, and PowerPoint.
• Strong problem-solving, critical thinking, and decision-making skills.
• Ability to work independently with minimal guidance.
• Willingness to travel up to 10%.

Responsibilities

• Support First Article Inspection (FAI) strategy development, execution, and approvals.
• Manage Production Part Approval Process (PPAP), change control processes, and change impact assessments.
• Assist with equipment and process validations, SOP updates, and risk management documentation reviews.
• Apply professional expertise to improve quality performance and ensure compliance with relevant regulations and standards.
• Work independently with minimal supervision in a fast-paced environment.
• Collaborate across multiple sites and build strong relationships with cross-functional teams.
• Communicate effectively in English, both verbally and in writing.

Skills

Quality engineering

Regulatory compliance

Problem-solving

Independent worker

Communication skills

Education

Bachelor's degree in Biomedical Engineering, Mechanical Engineering, or related field

Tools

Microsoft Word

Microsoft Excel

PowerPoint

Job description

GForce Life Sciences is seeking a Senior Quality Engineer to support quality assurance, control, and preventative activities within operations for a medical device environment in New Jersey. The role emphasizes FAI strategy, PPAP, change control, risk management, and validation activities, with collaboration across sites and cross-functional teams.

Requires EU-MDR experience, strong engineering/quality concepts, and the ability to travel up to 10%.