Senior Engineer, Quality Assurance Engineering

Judge Group, Inc.; Mahwah (NJ); Hybrid; USD 104,000 - 131,000; Full time

Benefits offered by this job

Medical, dental, and vision insurance

Hybrid work arrangement

Job summary

Judge Group, Inc. seeks a Senior Engineer, Quality Assurance for a 12-month+ contract in Mahwah, NJ. The role provides QA support across QA activities, including FAI strategy, PPAP, change control, validation, SOP and risk management, with cross-functional collaboration.

Hybrid role with on-site presence required. Requirements include a Bachelor’s in Biomedical/Mechanical Engineering, 4+ years’ experience, EU-MDR knowledge, ISO 13485/GDP/GMP familiarity, and strong MS Word/Excel/PowerPoint

Qualifications

• Bachelor’s degree in engineering or related field.
• 4+ years of industry experience.
• Experience with EU-MDR programs and quality systems.

Responsibilities

• Lead/advise on First Article Inspection (FAI) strategy and approvals.
• Manage PPAP and change control processes and assessments.
• Validate equipment and processes; maintain SOP and risk documentation.
• Collaborate with cross-functional teams to improve quality performance.

Skills

Quality assurance

QA engineering

Process control

Education

Bachelor’s Degree in Engineering

Tools

Microsoft Word

Microsoft Excel

PowerPoint

Job description

Location: Mahwah, NJ Salary: $50.00 USD Hourly – $63.00 USD Hourly Description: Our client is currently seeking a Senior Engineer, Quality Assurance Engineering for a 12 month + contract.

Medical, dental, and vision insurance are available to qualified candidates who meet eligibility requirements.

HYBRID ROLE – 3 days or more onsite

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

You will be tasked with developing and implementing methods and procedures for process control, process improvement, testing and inspection to ensure that the products are free of flaws and function as designed.

You will be expected to support:

• First Article Inspection (FAI) strategy development, execution, and approvals.

• Production Part Approval Process (PPAP)

• Change control processes and change impact assessments

• Equipment and Process validations

• SOP and Risk Management documentation updates and reviews

• And more

This is an individual contributor role that requires the use of judgement in applying professional expertise and is expected to work independently with minimal supervision. Roles typically require a university degree or an extensive amount of practical knowledge gained through experience. Job requires an understanding and application of procedures and concepts of own discipline. The job requires the ability to make judgements based on practice and previous experience.

You will advocate and lead the execution of initiatives & projects to enhance quality performance within the business and ensure compliance to regulations and standards.

Expected Qualifications:

Bachelor’s Degree – Biomedical Engineering, Mechanical Engineering or related field

4 + years of experience in industry required

Experience supporting EU-MDR programs

Knowledge of Change Management and Quality Management Systems (QMS) principles.

Firm understanding of Med Device concepts highly desirable.

Familiarity with ISO 13485 and EU Regulations, GDP, GMP concept highly desirable.

Excellent communication skills and attention to detail.

Good understanding of engineering and quality concepts / theories.

High level of PC skills. Must be proficient with Microsoft Word, Microsoft Excel and PowerPoint packages.

Self-starter with efficient work style and ability to handle multiple tasks in a fast-paced environment.

Be willing to work as part of a multi-site team.

Have knowledge of Risk Based and statistical concepts is desirable.

Problem solving and analytical skills.

Be able to build strong relationships by fostering open communications, respect and trust. Strong team player and acts with a customer service/stakeholder focused approach.

Ability to be the voice of Quality when dealing cross functionally.

Excellent English (both oral and written).

Up to 10% travel may be required

Bachelor’s Degree in Engineering field REQUIRED

Great problem solving and critical thinking skills (4+)

Able to independently use engineering rationale make decisions (4+)

Knowledge/Experience with Validation (2+)