We are seeking a dedicated and detail-oriented Quality Coordinator to join our quality department.

The ideal candidate will assist with various quality activities, including technical records management, supplier communication, and data management.

Key Responsibilities:

Assist with all quality activities and projects as directed by the Quality Assurance Manager.Compile and maintain technical records, product drawings, and material documentation.Reach out to suppliers to gather necessary information and maintain it in the system.Review customer product specifications for accuracy and compliance.Manage data related to product information and internal processes.Ensure products meet established quality and regulatory standards.Support the maintenance of the ERP system with accurate and current information.Investigate customer complaints and non-conformance issues.Participate in internal audits and support external audits conducted by regulatory bodies.Recommend and implement improvements to operational methods and practices.

Top 3 Must-Have Skills:

Attention to Detail: The role requires meticulous attention to detail, especially when handling technical records, product documentation, and customer specifications. Ensuring accuracy and compliance is crucial.Familiarity with Medical Devices and Regulations: Knowledge of medical devices, ISO standards (such as ISO 13485 and ISO 9001), and FDA regulations is essential. Understanding compliance requirements and regulatory standards will help maintain product quality and safety.Data Management and Analysis: Strong skills in data management and analysis are necessary for maintaining accurate records in the ERP system, managing product information, and supporting quality improvement initiatives. Proficiency in Microsoft Excel and Dynamics 365 is highly beneficial.

Qualifications:

Experience:Proven work experience in a Quality Assurance or Quality Control department.Knowledge of quality management systems and relevant standards.Experience with medical devices, biotechnology devices, and cleanrooms is a plus.Strong attention to detail and familiarity with medical devices and regulations.Proficiency in Microsoft Office, especially Excel, and experience with Dynamics 365.Knowledge of ISO 13485, ISO 9001, and FDA regulations is a plus.Excellent data management and analysis skills.Strong communication skills and ability to work closely with others.Ability to multitask efficiently in a desk-based role.Education:An Associate degree or equivalent work experience is preferred.Relevant certifications such as Quality Auditor, Quality Engineer, or Lean Six Sigma Green Belt are a plus.

Growth Opportunities: We value internal promotion and offer ample opportunities for career advancement. With 150 employees, we prioritize promoting from within as positions become available.

Salary: $25 per hour

Pay and Benefits

The pay range for this position is $22.00 - $25.00/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 Ronkonkoma,NY.

Application Deadline

This position is anticipated to close on Mar 17, 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 for other accommodation options.