Job Title: Quality Coordinator
Job Description

As a Quality Coordinator, you will assist with all quality activities and projects as directed by the Quality Assurance Manager. Your role will involve analyzing and investigating to improve products, processes, vital information, and data. You will address customer requests for information related to product specifications and the quality management system, ensuring products meet established quality and regulatory standards.

ResponsibilitiesAssist with all quality activities and projects as directed by the Quality Assurance Manager.Perform the role of an analyzer and investigator to improve products, processes, vital information, and data.Address customer requests for information related to product specifications and quality management system.Ensure products meet established standards of quality and regulatory requirements including reliability, usability, performance, and safety.Work with teams and committees to ensure products meet organizational standards.Support efforts to maintain accurate, precise, and current information in the ERP system.Collect, organize, and maintain material and product documentation for regulatory needs.Review customer specifications for accuracy.Create, revise, and release product drawings as needed.Assist in the coordination and release of product Change Notifications.Communicate with management to address and resolve issues.Recommend, implement, and direct others to modify and improve operational methods and practices.Investigate customer complaints and non-conformance issues and respond to requests for information from external and internal customers.Participate in corrective/preventive actions and root cause analysis.Conduct internal audits of all management systems as per the audit schedule.Support on-site audits conducted by external parties such as customers and regulatory bodies.Work on additional tasks and projects as directed by the Quality Assurance Manager.Essential SkillsQuality assuranceQuality controlQuality standardsAttention to detailFamiliarity with medical devices and regulationsKnowledge of ISO 9001 and FDA regulationsQuality management systemMicrosoft ExcelMicrosoft OfficeStrong computer skillsAdditional Skills & QualificationsKnowledge of medical devices, biotechnology devices, and cleanrooms is a plus.Knowledge of tools, concepts, and methodologies of manufacturing and validation processes, distribution, and environmental systems is a plus.Excellent communication skills; ability to work closely with others.Excellent data collection and analysis skills.Strong attention to detail.Ability to multitask efficiently.Work Environment

The work environment is primarily a cubicle/desk setting, with opportunities to go out on the floor to observe operations. The company offers a supportive work culture with benefits including 80% medical coverage, dental and vision insurance, 401k, and profit sharing.

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 24, 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.