Quality Engineer – Medical Device Manufacturing

***NO Visa Sponsorship/ No H1Bs/ No C2Cs***

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 – Medical Device Manufacturing

Position: Quality Engineer – Medical Device Manufacturing

Location: Mebane, North Carolina 27302

Duration: 5–6 Month Contract (Possible Extension)

Industry: Class III Medical Device Manufacturing

Pay Rate: $55/hr – $65/hr (depending on experience)

Available Shift Schedules

• 2nd Shift: Monday – Friday | 3:00 PM – 11:30 PM Eastern
• 3rd Shift: Monday – Friday | 11:00 PM – 7:30 AM Eastern

Work Schedule: On-site

Relocation Expenses/ Assistance: NO

NO Visa Sponsorship/ No H1Bs/ No C2Cs

Position Overview

The Quality Engineer will provide hands-on, on-the-production-floor quality engineering support for a Class III medical device manufacturing site. This role partners closely with production, manufacturing engineering, and operations leadership to identify and resolve quality issues in real time, contain defects, reduce nonconforming product, and strengthen manufacturing quality processes.

This position requires a strong daily presence on the production floor and a practical, compliance-focused approach to protecting product quality, patient safety, and regulatory compliance.

Key Responsibilities

• Provide daily quality engineering support for Class III medical device manufacturing operations.
• Monitor in-process manufacturing activities to identify, escalate, and contain quality defects before nonconforming product progresses downstream.
• Partner with operators, supervisors, technicians, and manufacturing engineers to quickly resolve production line issues while maintaining compliance with approved procedures and quality standards.
• Lead or support investigations involving nonconforming product, in-process failures, scrap, rework, and recurring quality concerns using structured root cause analysis methodologies.
• Drive corrective and preventive actions (CAPA) to reduce defect rates, improve yield, and prevent recurrence of production quality issues.
• Review production records, inspection results, trend data, and nonconformance reports to identify systemic issues and prioritize improvement opportunities.
• Support material review activities, nonconformance documentation, product disposition, deviation assessments, and containment implementation.
• Train and coach production personnel on defect awareness, inspection expectations, quality standards, and good documentation practices.
• Serve as the quality representative on the production floor, balancing manufacturing output with compliance, product quality, and patient safety.

Required Qualifications

• Bachelor’s degree in Engineering, Quality, Manufacturing, Biomedical Engineering, Mechanical Engineering, or a related technical discipline.
• Experience in a regulated manufacturing environment, preferably within medical device manufacturing.
• Knowledge of production quality support, nonconformance handling, root cause investigations, CAPA, and continuous improvement methodologies.
• Understanding of FDA quality system regulations, ISO 13485, and good documentation practices.
• Experience with in-process inspection, sampling plans, manufacturing controls, and defect prevention techniques.
• Ability to analyze manufacturing data and apply problem-solving tools such as:
• 5 Whys
• Fishbone Diagrams
• Pareto Analysis
• Basic Statistical Methods
• Strong communication and cross-functional collaboration skills.
• Ability to make sound quality decisions in a fast-paced manufacturing environment.
• Willingness to spend significant time on the production floor daily.

Preferred Qualifications

• Experience supporting Class III medical device manufacturing operations.
• Direct experience with:
• Production line quality support
• Material Review Board (MRB) activities
• Reduction of scrap, rework, and nonconforming product
• Knowledge of:
• Risk management principles
• Process validation
• Equipment qualification
• Change control within regulated environments
• Experience with statistical process control (SPC), process capability analysis, and manufacturing quality metrics.
• ASQ Certified Quality Engineer (CQE) or similar quality certification.
• Experience collaborating cross-functionally with operations, manufacturing engineering, and quality systems teams.

Recruiter Contact Info

Sajag Bhardwaj

Email: [email protected]

www.ameritconsulting.com

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.