Job Title: Quality Engineer IIJob Description The Quality Engineer II 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. Key skills include 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 (reviews and approvals only). + Act as a liaison with regulatory bodies during audits and inspections. + Monitor and report quality metrics, driving continuous improvement initiatives. Essential Skills + Bachelor's Degree in an Engineering discipline, preferably Biomedical, Mechanical, or Industrial. + Minimum of 3+ years of experience in Quality Engineering. + Experience with Risk Management (ISO preferred). + Experience with quality audits. + Experience with complaint handling, CAPAs, and NCRs. + Previous experience in the medical device industry. Additional Skills & Qualifications + Experience with Quality Engineering, Quality Assurance, and Quality Control. + Proficiency in root cause analysis and handling of non-conformance reports (NCRs). + Knowledge of Quality Management Systems and Inspection processes. Work Environment The position is based in Orangeburg, NY, within a medical device setting. You will be the sole Quality Engineer onsite in NY, with a Sr. Quality Manager in Buffalo, NY, and other Quality Engineers in Westboro, MA. The team consists of 23 members, and working hours are from 8:30am to 4:00pm. The role includes a 12-month contract position with potential for extension, 1 week of accrued vacation time, accrued sick time according to NYS regulations, and 6 paid holidays. 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 Mar 31, 2025. 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. Diversity, Equity & Inclusion At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through: + Hiring diverse talent + Maintaining an inclusive environment through persistent self-reflection + Building a culture of care, engagement, and recognition with clear outcomes + Ensuring growth opportunities for our people 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 process due to a disability, please email actalentaccommodation@actalentservices.com (%20actalentaccommodation@actalentservices.com) for other accommodation options.