Quality/Validation Engineer

matlen silver; Mahwah (NJ); Hybrid; USD 69,000 - 98,000; Part time

Job summary

Matlen Silver seeks a Quality/Validation Engineer in Mahwah, NJ on a 14-month contract with hybrid onsite schedule. You will support EU-MDR initiatives, perform FAI/PPAP activities, and ensure compliance across QA, QC and process validation.

The role requires a Bachelor's in Biomedical or Mechanical Engineering, 4+ years in medical device quality and strong ISO 13485 knowledge, plus proficiency with MS Office and cross-functional teamwork in a multi-site environment.

Qualifications

• Bachelor’s degree in Biomedical Engineering or Mechanical Engineering or related field
• 4+ years of experience in industry
• Experience supporting EU-MDR programs
• Knowledge of QMS and ISO 13485 concepts
• Proficient with MS Office suite

Responsibilities

• Provide quality engineering support in QA, control and preventative activities
• Support EU-MDR initiatives
• Develop and implement methods for process control, process improvement, testing and inspection
• Lead First Article Inspection (FAI) strategy development, execution and approvals
• Support Production Part Approval Process (PPAP)
• Execute change control and assess change impact
• Support SOP and risk documentation updates and reviews
• Equipment and process validations
• Collaborate with multi-site team to enhance quality performance

Skills

Quality engineering

FAI

PPAP

Change control

SOP & documentation

Risk management

EU MDR understanding

ISO 13485 knowledge

Statistical methods

Strong communication

Team collaboration

Education

Bachelor's Degree - Biomedical Engineering, Mechanical Engineering or related field

Tools

Microsoft Word

Microsoft Excel

PowerPoint

Job description

Job Title

Job Title: Quality/Validation Engineer

Pay Rate: $60.52/hr

Location: Mahwah New Jersey 07430

Schedule: Hybrid (3-4 days on-site)

Position: Contract

Duration: 14 months

Work Authorization: W2 (No C2C)

Job Description

Summary

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 specifically tasked with supporting EU-MDR initiatives for a portfolio of products. To do so you will develop and implement methods and procedures for process control, process improvement, testing and inspection to ensure that the products are compliant to applicable regulations, 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 and change impact assessments
• Support SOP and Risk Documentation updates and reviews
• Equipment and Process validations
• 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