Quality Engineer

Job Title:

Quality Engineer Job Description 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. Responsibilities 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. Essential Skills Supplier quality, ISO, QMS, Medical device, CAPA, Quality engineering, Root cause analysis, Quality management system, Engineering, Quality management, Corrective action plans, Validation. Additional Skills & Qualifications 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. Work Environment 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. Job Type & Location This is a Contract to Hire position based out of Emerson, NJ. Pay and Benefits The pay range for this position is $33.65 - $38.46/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 Emerson,NJ.

Application Deadline This position is anticipated to close on Apr 6, 2026. Diversity, Equity & Inclusion At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I is 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 Actalent is an equal opportunity employer. About Actalent Actalent is a global leader in engineering and sciences services. For more than 40 years, we've helped visionary companies advance their goals. Headquartered in the United States, our teams span 150 offices across North America, EMEA, and APAC—with four delivery centers in India led by 1,000+ extraordinary employees who connect their passion with purpose every day. Our Bangalore, Hyderabad, Pune, and Chennai delivery centers are hubs of engineering expertise, with core capabilities in mechanical and electrical engineering, systems and software, and manufacturing engineering. Our teams deliver work across multiple industries including transportation, consumer and industrial products, and life sciences. We serve more than 4,500 clients, including many Fortune 500 brands. Learn more about how we can work together at actalentservices.com.