• Quality Engineer

    Actalent (Orangeburg, NY)


    Job Title: Quality Engineer

    Job Description

    The Sr. 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. The main skills are complaint handling, 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 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 IQ, OQ, and 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 processes

    + ISO standards

    + Medical device industry experience

    + Quality control

    + Root cause analysis

    + Complaint handling

    + NCRs

    + Quality management systems

    + 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 (ISO preferred).

    + Experience with quality audits required.

    + Previous medical device industry experience.

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

    Work Environment

    Work hours are from 8:30 am to 4:00 pm in a medical device setting. The position is the sole Quality Engineer onsite in NY, with the Sr. Quality Manager in Buffalo, NY, and other Quality Engineers in Westboro, MA. Benefits include a 12-month contract that may be extended, with 1 week accrued vacation time, accrued sick time (NYS), 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.

     

    Application Deadline

     

    This position is anticipated to close on Jan 6, 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 [email protected] (%[email protected]) for other accommodation options.