• Sr. Quality Engineer

    Actalent (Orangeburg, NY)


    We are seeking an experienced Sr. Quality Engineer to lead quality assurance initiatives within a medical device manufacturing environment.

     

    This role ensures compliance with regulatory and company standards and serves as a key technical resource for cross-functional teams.

     

    You will be the sole Quality Engineer onsite in Orangeburg, NY, collaborating closely with remote quality leadership and engineering teams.

    Key Responsibilities

    + Perform quality activities supporting operations, contract manufacturers, and R&D.

    + Lead quality activities related to CAPA processes and NCRs.

    + Support internal and external audits; resolve audit nonconformities.

    + Represent Quality Engineering in risk assessments (e.g., FMEAs) and maintain risk management documentation per ISO 14971.

    + Participate in Material Review Board reviews, including segregation, investigation, and disposition.

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

    + Oversee process validation activities (IQ, OQ, PQ) – review and approve protocols and reports.

    + Act as liaison with regulatory bodies during audits and inspections.

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

    Required Skills & Experience

    + Bachelor’s degree in Engineering (Biomedical, Mechanical, or Industrial preferred).

    + 5+ years of Quality Engineering experience in the medical device industry.

    + Strong knowledge of ISO 13485 and ISO 14971 standards.

    + Hands-on experience with CAPAs, NCRs, complaint handling, and root cause analysis.

    + Experience with quality audits and risk management processes.

    Nice-to-Have Skills

    + Quality Management Systems (QMS)

    + Inspection and Quality Control

    + Supplier Quality experience

    Employee Value Proposition

    + 12-month contract with potential extension.

    + Competitive pay.

    + Benefits include 1 week accrued vacation, NYS sick time, and 6 paid holidays.

    + Opportunity to lead quality initiatives in a growing medical device organization.

    Work Environment

    + Medical device manufacturing setting.

    + Team of 23 onsite; Sr. Quality Manager based in Buffalo, NY.

    + Sole QE onsite in Orangeburg, NY.

     

    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 19, 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.