Quality Engineer, New York

Our client has over 60 Years of Innovation — And Still Going Strong!

For more than six decades, they've been powering the dental industry with reliable, cutting-edge solutions — helping professionals stay Equipped for Life. From small practices to major institutions, their technology makes a real difference every day.

They're not just about great products — they're about purpose. Through global partnerships, they're helping build schools and support communities, creating lasting impact beyond dentistry.

With a strong commitment to quality, innovation, and social responsibility, they are shaping the future.

Essential Functions and Responsibilities:

Review customer complaints, conduct product investigations, and ensure proper complaint closure

Conduct medical device reporting assessments and investigations

Develop sampling plans for evaluating, and reporting quality and reliability data

Demonstrate continuous effort to improve product quality and manufacturing processes

Participates on Project Team as Quality Representative. Ensures that principals of Design Control are applied to Product and Process Changes and New Product Development

Provides Quality Assurance leadership for Project Teams or Quality Department

Creates reviews and approves Quality System Documents (ex. CAPA, Audits)

Creates reviews and approves Product Documents

Creates, reviews, and approves Protocols, Process and Product Validations, Stability Protocols, Software Validation documents

Reviews and inspect Device History Records to ensure document accuracy, verify that product quality meets standards and authorize release of the product for distribution.

Mentors entry point staff

Provides supervision to technicians and junior engineers

Assists in the review and interviews of potential candidates

Creates reviews and approves documents required for Design History File

Creates reviews and approves Risk Assessments such as FMEA, FMECA or FTA

Analyzes process and product non-conformances and implement comprehensive corrective and preventive action plans

Performs Internal or Supplier Quality System Audits

Ensures compliance to Department procedures

Tracks and trends Quality Indicators

Serves as Independent QA Reviewer and Chairperson for Design Reviews

Work Experience Requirements:

Quality Engineering and Customer Complaint Investigation experience

Working knowledge of standards and regulations, including but not limited to US-FDA's 21 CFR Part 820 and 21 CFR Part 803, and GMP

Medical Device Industry experience and working knowledge of ISO-13485 preferred Quality management systems, and ISO 14971 Medical devices

Education Requirements:

Bachelor's degree in an engineering/scientific or quality management curriculum required plus a minimum of 5 years work experience in Quality Assurance within an FDA, ISO or similarly regulated environment and/or equivalent combination of education and experience

Master's degree preferred, with a minimum of 2 years work experience in Quality Assurance within an FDA, ISO or similarly regulated environment and/or equivalent combination of education and experience

Experience in the development and implementation of effective Design Control Systems

Nesco Resource offers a comprehensive benefits package for our associates, which includes a MEC (Minimum Essential Coverage) plan that encompasses Medical, Vision, Dental, 401K, and EAP (Employee Assistance Program) services.

Nesco Resource 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.