Manufacturing Senior Quality Assurance Engineer - Hybrid

Radiant Systems Inc; Mahwah (NJ); Hybrid; USD 83,000 - 90,000; Full time

Job summary

Major Medical Device Client is seeking a Manufacturing Senior Quality Assurance Engineer to join our hybrid team in Mahwah, NJ. You will lead quality assurance activities for EU-MDR initiatives, develop process controls, and collaborate with design, manufacturing engineering, and project managers to ensure regulatory compliance and defect-free products.

The role emphasizes PPAP/FAI execution, change management, and supporting SOP updates in a fast-paced manufacturing setting.

Qualifications

• Bachelor’s degree in Biomedical or Mechanical Engineering.
• 4+ years of relevant industry experience.
• Experience supporting EU-MDR programs and initiatives.

Responsibilities

• Develop, execute, and approve FAI strategies.
• Support PPAP activities and change control.
• Review SOPs and risk documentation updates.
• Review and approve FAI and related inspections (FAI).
• Collaborate with cross‑functional teams on deliverable updates and project strategy.
• Provide quality engineering support for EU-MDR initiatives across product portfolio.

Skills

Problem solving

Decision making

EU-MDR

Education

Biomedical/Mechanical Eng

Job description

We are hiring Manufacturing Senior Quality Assurance Engineer - Hybrid.

Client: Major Medical Device Client

Position: Manufacturing Senior Quality Assurance Engineer - Hybrid

Duration: 14+ months on W2

Location: Mahwah, New Jersey 07430

Pay Rate: $60.00-$65.00/ Hr on W2

Job Description

Must-Have Skills

• Strong problem-solving and critical-thinking skills (4+ years).
• Ability to independently apply engineering rationale to make decisions (4+ years).
• Knowledge and experience with EU-MDR programs and initiatives (2+ years).

Nice-to-Have Skills

• Ability to follow timelines and track deliverables.
• Self-starter with a proactive approach.

Day-to-Day Activities

• Participate in project team meetings and provide progress updates.
• Plan, execute, and obtain approvals for Production Part Approval Process (PPAP) activities.
• Review SOPs and procedures and collaborate with document authors.
• Review and approve First Article Inspections (FAI).
• Meet with cross-functional teams, including design, manufacturing engineering, and project managers, to discuss deliverable updates and overall project strategy.

Job Description

As a Senior Quality Engineer, you will provide quality engineering support for quality assurance, control, and preventive activities within operations and other business functions.

You will be specifically responsible for supporting EU-MDR initiatives across a portfolio of products.

You will develop and implement methods and procedures for process control, process improvement, testing, and inspection to ensure that products comply with applicable regulations, are free of defects, and function as designed.

Key Responsibilities

• Develop, execute, and approve First Article Inspection (FAI) strategies.
• Support Production Part Approval Process (PPAP) activities.
• Manage change control and change impact assessments.
• Support SOP and risk documentation updates and reviews.
• Support equipment and process validations.
• Perform additional quality engineering responsibilities as required.

Expected Qualifications

• Bachelor’s degree in Biomedical Engineering, Mechanical Engineering, or a related engineering field (required).
• 4+ years of relevant industry experience.
• Experience supporting EU-MDR programs and initiatives.
• Knowledge of change management and Quality Management System (QMS) principles.
• Strong understanding of medical device concepts is highly desirable.
• Familiarity with ISO 13485, EU regulations, Good Documentation Practices (GDP), and Good Manufacturing Practices (GMP) is highly desirable.
• Excellent communication skills and attention to detail.
• Good understanding of engineering and quality concepts and theories.
• Proficiency in Microsoft Word, Excel, and PowerPoint.
• Self-starter with an efficient work style and the ability to manage multiple tasks in a fast-paced environment.
• Ability to work effectively as part of a multi-site team.
• Knowledge of risk-based approaches and statistical concepts is desirable.
• Strong problem-solving and analytical skills.
• Ability to build strong relationships through open communication, respect, and trust.
• Strong teamwork skills and a customer- and stakeholder-focused approach.
• Ability to represent Quality effectively in cross-functional discussions.
• Excellent written and verbal English communication skills.
• Willingness to travel up to 10% as required.