Quality Engineer

Overview

Our client, a US Fortune 250 company and a global medical technology corporation serving customers in Clinical Labs, Health care research & Pharmaceutical industry, seeks an accomplished
Quality Engineer.

Job Title:
Quality Engineer

Location:
Franklin Lakes, NJ (Hybrid – 2 days onsite, remainder remote)

Duration:
12-month contract with possible extension

Pay Rate:
$40/hr - $48/hr (depending on experience)

Schedule:

• Hybrid (2 days onsite, remainder remote)
• Domestic travel required

Must-Have Requirements:

• Bachelor's degree in Science, Engineering, or related field
• Minimum 5 years of experience in medical device quality engineering
• Knowledge of FDA regulations (21 CFR Part 820) and ISO 13485 standards
• Experience with risk management, CAPA, and design control

Job Description:

The Quality Engineer supports new product development and ongoing product maintenance by applying quality engineering principles to medical device projects. This role manages tasks from product inception through launch and sustaining phases, ensuring products meet internal and regulatory quality standards in compliance with corporate and unit policies.

Responsibilities:

• Apply technical principles, theories, and quality science tools to assigned projects.
• Demonstrate strong problem-solving skills to improve processes and procedures.
• Ensure all design control and production/process control activities comply with applicable corporate, unit, and regulatory requirements (local and international).
• Represent the Quality function on new product development and sustaining engineering teams.
• Review and provide Quality Engineering approval for new and modified design/process specifications, including product performance specifications and test methods.
• Support supplier and internal quality system audits to assess compliance with the Quality System and Good Manufacturing Practices (GMP).
• Contribute to continuous improvement initiatives and other related duties as assigned.

Minimum Qualifications:

• Bachelor's degree in Science, Engineering, or related field
• Minimum 5 years of relevant experience in medical device quality engineering

Additional Qualifications:

• In-depth understanding of FDA medical device quality system regulations and international standards (ISO 13485, ISO 14971, MDSAP, EU MDR/IVDR)
• Proven ability to deliver high-quality project execution, including design, data analysis, and reporting
• Experience revising policies/procedures and delivering presentations
• Ability to independently develop and implement solutions

Preferred Qualifications:

• Specialized knowledge in acceptance sampling, SPC, measurement systems, DOE, risk management, supplier quality, and process validation

Recruiter Contact Info

Sajag Bhardwaj

I'd love to talk to you if you think this position is right up your alley, and assure prompt communication, whichever direction. If you're looking for rewarding employment and a company that puts its employees first, we'd like to work with you.

Company Overview:

Amerit Consulting is an extremely fast-growing staffing and consulting firm. Amerit Consulting was founded in 2002 to provide consulting, temporary staffing, direct hire, and payrolling services to Fortune 500 companies nationally; as well as small to mid-sized organizations on a local & regional level. Currently, Amerit has over 2,000 employees in 47 states. We develop and implement solutions that help our clients operate more efficiently, deliver greater customer satisfaction, and see a positive impact on their bottom line. We create value by bringing together the right people to achieve results. Our clients and employees say they choose to work with Amerit because of how we work with them - with service that exceeds their expectations and a personal commitment to their success. Our deep expertise in human capital management has fueled our expansion into direct hire placements, temporary staffing, contract placements, and additional staffing and consulting services that propel our clients' businesses forward.

Amerit Consulting provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.

This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation and training. Applicants, with criminal histories, are considered in a manner that is consistent with local, state and federal laws.