Job Title: Quality Engineer

Job Description

We are looking for a Quality Engineer who will be responsible for establishing and maintaining the Quality Management System (QMS) per ISO/IEC 9001:2015 standards. The successful candidate will ensure the integrity of the QMS during changes, develop and maintain quality manuals and procedures, and prepare for external audits. This role requires proactive management of internal audits and training internal auditors, ensuring all employees understand their roles in maintaining QMS compliance.

Responsibilities

• Establish and maintain the Quality Management System (QMS) per ISO/IEC 9001:2015.

• Ensure the integrity of the QMS during planned changes.

• Develop, review, and maintain quality manuals, policies, objectives, procedures, work instructions, and forms to comply with ISO 9001:2015 and FDA requirements for Class II medical devices.

• Prepare for external audits and manage communication with third-party agencies such as IMSM and FDA.

• Maintain accurate records of the Quality Management System for external audits.

• Develop and maintain an internal audit program to identify compliance issues or relevant changes to the QMS.

• Review internal QC processes and coordinate with internal departments to ensure adherence to ISO requirements.

• Train and ensure the competency of internal auditors.

• Ensure all employees understand the QMS and their role in maintaining compliance.

Essential Skills

• Experience with quality management systems.

• Lead Auditor certification.

• Project management skills.

• Quality engineering experience, including starting up a QMS.

• ISO 9001 and ISO 13845 experience.

• Ability to lead and manage projects.

• Root cause analysis skills.

Additional Skills & Qualifications

• BA degree in an engineering-related field.

• 5+ years of experience in Quality Engineering working with quality management systems.

• Experience working in a medical device environment.

Pay and Benefits

The pay range for this position is $43.00 - $52.00/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 Fort Lee,NJ.

Application Deadline

This position is anticipated to close on Apr 11, 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.