Quality Engineer

Location: Orangeburg

Job Title:

Senior Quality Engineer

Job Description

The Senior Quality Engineer is responsible for leading quality assurance initiatives, ensuring that processes, products, and systems comply with regulatory and company standards. This position serves as a technical resource for cross-functional teams, focusing on complaint handling, non-conformance reports (NCRs), root cause analysis, and leading audits.

Responsibilities

* Perform quality activities in support of operations, contract manufacturers, and R&D.

* Support design and engineering change processes and associated documentation.

* Support internal and external audit activities and work to resolve audit nonconformities.

* Lead quality activities related to Corrective and Preventive Action (CAPA) processes.

* Represent Quality Engineering in the development and maintenance of process and product risk assessments.

* Participate in Material Review Board reviews, including material segregation, investigation, corrections, and dispositions.

* Design and implement robust quality controls for new and existing processes.

* Develop and maintain risk management documentation in alignment with ISO standards.

* Oversee process validation activities, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) protocols and reports.

* Act as a liaison with regulatory bodies during audits and inspections.

* Monitor and report quality metrics, driving continuous improvement initiatives.

Essential Skills

* Quality engineering

* Quality assurance

* CAPA

* ISO standards

* Medical device industry experience

* Quality control

* Root cause analysis

* Complaint handling

* NCRs

* Process Validation

* Quality management system

* Inspection

Additional

Skills & Qualifications

* Bachelor's Degree in an Engineering discipline, preferably Biomedical, Mechanical or Industrial.

* Minimum of 5+ years of experience in Quality Engineering.

* Experience with Risk Management, preferably ISO standards.

* Experience with quality audits required.

* Previous medical device industry experience.

* Experience with complaint handling, CAPAs, and NCRs required.

Work Environment

This is a full-time, 12-month contract position with a medical device manufacturer located in Orangeburg, NY. The role operates within a team of 23, from 8:30 AM to 4:00 PM. The work setting is a medical device environment, where you will be the sole Quality Engineer onsite in NY. The Senior Quality Manager is based in Buffalo, NY, with other Quality Engineers in Westboro, MA.

The position offers 1 week of accrued vacation time, accrued sick time, and 6 paid holidays.

Job Type & Location

This is a Contract position based out of Orangeburg, NY.

Pay and Benefits

The pay range for this position is $40.87 - $48.08/hr.

Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following:
• Medical, dental & vision
• Critical Illness, Accident, and Hospital
• 401(k) Retirement Plan - Pre-tax and Roth post-tax contributions available
• Life Insurance (Voluntary Life & AD&D for the employee and dependents)
• Short and long-term disability
• Health Spending Account (HSA)
• Transportation benefits
• Employee Assistance Program
• Time Off/Leave (PTO, Vacation or Sick Leave)

Workplace Type

This is a fully onsite position in Orangeburg,NY.

Final date to receive applications

This position is anticipated to close on Mar 7, 2026.

About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.

The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing due to a disability, please email actalentaccom for other accommodation options.