Quality Engineer

The Quality Engineer will play a pivotal role in coordinating regulatory submissions and providing strategic regulatory advice to project teams. This position requires an individual who can stay informed about global regulatory changes, offer recommendations, and work directly with regulatory authorities. The Quality Engineer will also conduct audits, evaluate SOPs, and manage customer-related quality issues, ensuring that the company's quality goals and objectives are met.

• Collect documentation and coordinate with cross-functional teams to prepare regulatory submissions to regulatory agencies.
• Create and maintain regulatory submission timelines and track deliverables to ensure company goals are met.
• Provide strategic input and regulatory advice to project teams and development programs.
• Stay informed about the current regulatory landscape for medical devices globally.
• Develop recommendations regarding new/emerging regulations and communicate them to management and project teams.
• Represent the company and work directly with regulatory authorities on regulatory issues and submissions.
• Provide in-house training on quality/regulatory-related issues.
• Support international RA and QA efforts and collaborate with other teams across the company as needed.
• Review quality system processes to improve awareness, visibility, and communication on quality initiatives.
• Conduct onsite audits and host regulatory agency audits as needed.
• Evaluate, author, and review SOPs, Forms, and Work Instructions.
• Handle customer-related quality issues.
• Prioritize daily tasks to ensure 'on-time' processing.
• Establish and maintain an import and export compliance program.
• Assist Shipping/Receiving/Warehouse/Repairs personnel.
• Recommend measures to motivate employees to improve operation methods and product quality.
• Perform physical inventory checks with Purchasing.
• Observe and monitor gauges, dials, and other indicators to ensure SOP compliance.
• Perform all aspects of building management, including safety and sanitation regulations.
• Maintain commitment to Quality Goals and Quality Policy.
• Complete jobs and tasks as assigned.

• Supplier quality, ISO, QMS, Medical device, CAPA, Quality engineering, Root cause analysis, Quality management system, Engineering, Quality management, Corrective action plans, Validation.

• Bachelor's degree or associate degree required.
• Minimum 4 years of relevant work experience required.
• ISO Certificate and/or strong knowledge.
• Audit Experience.
• Medical Device Experience.
• Knowledge of QMS Systems.
• Strong organizational skills.
• Strong communication skills.
• Ability to follow written and verbal instructions.
• Ability to work in a group and independently.
• Reliable, responsible, detail-oriented.
• Experience with staff supervision required.
• Experience with Export/Import preferred.

The work environment offers flexible hours, allowing a start time between 8:30 am and 9:00 am. Enjoy summer hours with early out on Fridays during summer. The office is undergoing renovations to revamp and update workspaces. This position is within the medical device industry, which contributes to the betterment of the world while maintaining a family feel and a tight-knit environment.

This is a Contract to Hire position based out of Sparta, NJ.

The pay range for this position is $36.06 - $52.88/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)

This is a fully onsite position in Sparta,NJ.

This position is anticipated to close on Mar 18, 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 actalentaccommodation@actalentservices.com for other accommodation options.

Salary : $36 - $53