Senior QA Engineer - Medical Devices

The Matlen Silver Group, Inc.; Mahwah (NJ); On-site; USD 90,000 - 130,000; Full time

Benefits offered by this job

Health, vision, and dental insurance (

401(k) plan

Job summary

The Matlen Silver Group, Inc. is seeking a Senior QA Engineer for Medical Devices to join our team in Mahwah, NJ onsite. This contract role requires 4+ years in the industry, validation experience, and familiarity with EU MDR and QMS principles.

A Bachelor’s degree in engineering is required, with USC/GC candidates preferred. Responsibilities include supporting change management and quality concepts, ensuring regulatory compliance, and contributing to risk-based decision making in a fast-paced

Qualifications

• Bachelor’s degree in engineering or related field.
• 4+ years of industry experience in QA/validation.
• Experience with validation activities and change control.

Skills

Engineering judgment

Validation

Quality Management

EU MDR knowledge

Risk-based thinking

Statistical concepts

Education

Bachelor’s Degree in Engineering

Tools

SOP development

FAI

PPAP

Job description

Senior QA Engineer - Medical Devices (BH-111087)

Location Mahwah, United States Sector Manufacturing & Production Salary Competitive

Job Title: Senior QA Engineer - Medical Devices

Duration: 12 months contract

Location: Mahwah, NJ (Onsite)

NO C2C, ONLY W2 ***Due to client requirements this role is only open to USC or GC candidates***

Job Summary

Must Haves:

• Bachelor’s Degree in Engineering field
• Able to independently use engineering rationale make decisions (4+)
• Knowledge/Experience with Validation (2+)
• 4 + years of experience in industry required
• Experience supporting EU-MDR programs
• Knowledge of Change Management and Quality Management Systems (QMS) principles.
• Good understanding of engineering and quality concepts / theories.
• Have knowledge of Risk Based and statistical concepts is desirable.

Desired Skills

• Experience developing or approving SOPs
• Firm understanding of Med Device concepts highly desirable.
• Familiarity with ISO 13485 and EU Regulations, GDP, GMP concept highly desirable.
• FAI, PPAP

About Matlen Silver

Experience Matters. Let your experience be driven by our experience. For more than 40 years, Matlen Silver has delivered solutions for complex talent and technology needs to Fortune 500 companies and industry leaders. Led by hard work, honesty, and a trusted team of experts, we can say that Matlen Silver technology has created a solutions experience and legacy of success that is the difference in the way the world works.

Matlen Silver is an Equal Opportunity Employer and considers all applicants for all positions without regard to race, color, religion, gender, national origin, age, sexual orientation, veteran status, the presence of a non-job-related medical condition or disability, or any other legally protected status.

If you are a person with a disability needing assistance with the application or at any point in the hiring process, please contact us at email and/or phone at: [e-mail] // 908-393-8600

At The Matlen Silver Group, Inc., W2 employees are eligible for the following benefits:

• Health, vision, and dental insurance (single and family coverage)
• 401(k) plan (employee contributions only)