Senior Quality Engineer

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

Our client, a medical device organization, has engaged GForce Life Sciences to provide a Senior Quality Engineer. This position will support quality assurance, control, and preventative activities within operations. The role involves developing and implementing methods for process control, testing, inspection, and supporting validation activities to ensure products are free of flaws and function as designed.

DUTIES / EXPECTATIONS OF ROLE

• 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.

Mandatory Requirements

• 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%.

NICE TO HAVE

• Experience with ISO 13485 and EU Regulations, GDP, GMP concepts.
• Familiarity with Med Device concepts.
• Knowledge of risk-based and statistical concepts.
• Experience with validation activities (2+ years).
• Excellent communication skills, attention to detail, and stakeholder-focused approach.