Quality Engineer Position Available In Suffolk, New York

Job Description:

Our client has over 60 Years of Innovation — And Still GoingStrong! For more than six decades, they’ve been powering the dentalindustry with reliable, cutting-edge solutions — helpingprofessionals stay Equipped for Life . From small practices tomajor institutions, their technology makes a real difference everyday. They’re not just about great products — they’re about purpose.

Through global partnerships, they’re helping build schools andsupport communities, creating lasting impact beyond dentistry. Witha strong commitment to quality, innovation, and socialresponsibility, they are shaping the future.

Essential Functionsand Responsibilities:

Review customer complaints, conduct productinvestigations, and ensure proper complaint closure Conduct medicaldevice reporting assessments and investigations Develop samplingplans for evaluating, and reporting quality and reliability dataDemonstrate continuous effort to improve product quality andmanufacturing processes Participates on Project Team as QualityRepresentative. Ensures that principals of Design Control areapplied to Product and Process Changes and New Product DevelopmentProvides Quality Assurance leadership for Project Teams or QualityDepartment Creates reviews and approves Quality System Documents(ex. CAPA, Audits) Creates reviews and approves Product DocumentsCreates, reviews, and approves Protocols, Process and ProductValidations, Stability Protocols, Software Validation documentsReviews and inspect Device History Records to ensure documentaccuracy, verify that product quality meets standards and authorizerelease of the product for distribution. Mentors entry point staffProvides supervision to technicians and junior engineers Assists inthe review and interviews of potential candidates Creates reviewsand approves documents required for Design History File Createsreviews and approves Risk Assessments such as FMEA, FMECA or FTAAnalyzes process and product non-conformances and implementcomprehensive corrective and preventive action plans PerformsInternal or Supplier Quality System Audits Ensures compliance toDepartment procedures Tracks and trends Quality Indicators Servesas Independent QA Reviewer and Chairperson for

Design Reviews WorkExperience Requirements:

Quality Engineering and Customer ComplaintInvestigation experience Working knowledge of standards andregulations, including but not limited to US-FDA’s 21 CFR Part 820and 21 CFR Part 803, and GMP Medical Device Industry experience andworking knowledge of

ISO-13485

preferred Quality managementsystems, and

ISO 14971

Medical devices

Education Requirements:

Bachelor’s degree in an engineering/scientific or qualitymanagement curriculum required plus a minimum of 5 years workexperience in Quality Assurance within an FDA, ISO or similarlyregulated environment and/or equivalent combination of educationand experience Master’s degree preferred, with a minimum of 2 yearswork experience in Quality Assurance within an FDA, ISO orsimilarly regulated environment and/or equivalent combination ofeducation and experience Experience in the development andimplementation of effective Design Control Systems Nesco Resourceoffers a comprehensive benefits package for our associates, whichincludes a MEC (Minimum Essential Coverage) plan that encompassesMedical, Vision, Dental, 401K, and EAP (Employee AssistanceProgram) services. Nesco Resource provides equal employmentopportunities to all employees and applicants for employment andprohibits discrimination and harassment of any type without regardto race, color, religion, age, sex, national origin, disabilitystatus, genetics, protected veteran status, sexual orientation,gender identity or expression, or any other characteristicprotected by federal, state, or local laws.