Quality Engineer

Actalent; Edison (NJ); On-site; USD 100,000 - 120,000; Full time

Benefits offered by this job

Medical insurance

401k with company match

Paid vacation and sick time

Job summary

Actalent is seeking a Quality Engineer for our Edison, NJ site to lead and improve the Quality Management System for Class II medical devices. The role ensures compliance with ISO 9001:2015 and FDA requirements while guiding cross-functional teams through quality initiatives.

The successful candidate will drive supplier quality, support new product development, and prepare for audits. This is a fully onsite permanent role at Edison, NJ with a strong emphasis on continuous improvement and

Qualifications

• Bachelor's degree in engineering required.
• 5+ years of quality engineering experience in medical devices.
• Familiar with ISO-based QMS incl. ISO 9001:2015.
• Experience with FDA requirements for Class II devices.
• Experience preparing for and supporting external audits.

Responsibilities

• Implement and maintain a quality program aligned with ISO 13485 and FDA requirements.
• Maintain and improve the Quality Management System per ISO 9001:2015 and FDA standards.
• Develop and maintain Quality Manual, policies, procedures, and forms.
• Coordinate external audits and interact with certifying bodies and FDA.
• Lead internal audit programs and drive improvements in QMS.

Skills

Bachelor degree in engineering

5+ years quality engineering

ISO 9001:2015 awareness

FDA regulatory knowledge

Internal audit experience

Cross-functional collaboration

Quality system management

Supplier quality management

Quality improvement leadership

Education

Bachelor’s degree in engineering

Job description

Job Title: Quality Engineer

Job Description

The Quality Engineer leads the implementation, maintenance, and continuous improvement of a comprehensive Quality Management System for Class II medical devices. This role provides strategic direction for product quality and reliability, ensures compliance with ISO 9001:2015 and FDA requirements, and drives a culture of continuous improvement across the organization. The Quality Engineer collaborates closely with cross-functional teams to support new product development, supplier quality, and operational excellence.

Responsibilities

• Implement and maintain a robust quality program aligned with ISO 13485 and FDA requirements for medical devices.

• Maintain, review, and continuously improve the Quality Management System based on ISO/IEC 9001:2015 and upcoming standards.

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

• Prepare for external audits and manage all communication with third-party certifying agencies and the FDA during audits, inspections, and investigations.

• Maintain complete and accurate Quality Management System records to ensure readiness for external audits.

• Develop and maintain internal audit programs to proactively identify compliance issues and drive relevant changes to the Quality Management System.

• Review internal quality control processes and coordinate with internal departments to ensure adherence to ISO and FDA requirements.

• Interface with Product Development, Engineering, Purchasing, and Logistics teams to provide expert quality guidance throughout the product lifecycle.

• Collaborate with the sourcing team to drive supplier quality performance and ensure suppliers meet established quality standards.

• Support operations facilities during customer and third-party audits, including developing and implementing effective corrective actions as needed.

• Provide strategic direction for product quality and reliability objectives and oversee the implementation and management of the Quality System.

• Implement and promote a culture of continuous improvement to support the achievement of product quality and reliability goals.

• Coordinate and lead cross-functional projects and special initiatives related to quality, compliance, and process improvement.

• Support cross-functional teams in the implementation of new product development projects, ensuring quality and regulatory requirements are met.

• Create and foster a positive working environment that encourages creative thinking, collaboration, and engagement across teams.

Essential Skills

• Bachelors degree in engineering.

• 5+ years of quality engineering experience in the medical device industry.

• Proven experience with ISO-based Quality Management Systems, including ISO 9001:2015.

• Hands-on experience implementing and maintaining quality programs for medical devices.

• Demonstrated experience working with FDA requirements for Class II medical devices.

• Strong knowledge of FDA regulations and audit expectations for medical device manufacturers.

• Experience preparing for and supporting external audits, including third-party and regulatory audits.

• Ability to develop, maintain, and improve quality manuals, policies, procedures, work instructions, and forms.

• Experience developing and executing internal audit programs for Quality Management Systems.

• Strong collaboration skills with Product Development, Engineering, Purchasing, Logistics, and Operations teams.

• Proven ability to drive supplier quality performance in partnership with sourcing or supply chain teams.

• Experience supporting operations during customer and third-party audits and developing corrective actions.

• Demonstrated ability to lead quality initiatives that support product reliability and continuous improvement.

Additional Skills & Qualifications

• Experience with ISO 13485 or similar medical device quality standards.

• Familiarity with ISO/IEC 9001:2015 and upcoming revisions or related standards.

• Background in implementing and sustaining a culture of continuous improvement.

• Experience coordinating cross-functional teams and managing special projects related to quality or new product development.

• Strong communication skills for interacting with internal teams, external auditors, and regulatory bodies.

• Ability to influence and guide teams in adopting quality best practices and process improvements.

• Experience in a strategic quality role with responsibility for product quality and reliability objectives.

Work Environment

The role is based at a fast-paced operations site in Edison, NJ. The Quality Engineer works closely with on-site operations, engineering, and cross-functional teams in a dynamic environment focused on medical device production and compliance. The position involves regular interaction with internal departments, suppliers, and external auditors, as well as active participation in audits, investigations, and project meetings.

Job Type & Location

This is a Permanent position based out of Edison, NJ.

Pay and Benefits

The pay range for this position is $100000.00 - $120000.00/yr.

Individual compensation offered for this position within this range will depend on many factors, including qualifications, skills, relevant experience, job knowledge, geographic location, internal equity, and other pertinent job-related factors.

Medical/Dental insurance (some employee contribution is required) Company paid vision and life insurance. Transit check and 125 medical plans. 401k with a company match. Paid vacation and sick time. Discretionary bonuses and profit sharing.

Job Type & Location

This is a Permanent position based out of Edison, NJ.

Application Deadline

This position is anticipated to close on Nov 18, 2026.

Workplace Type

This is a fully onsite position in Edison,NJ.

About Actalent

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 [e-mail] for other accommodation options.

San Francisco Fair Chance Ordinance: Pursuant to the San Francisco Fair Chance Ordinance, for all positions located in the city and county of San Francisco, we will consider for employment qualified applicants with arrest and conviction records.

Massachusetts Lie Detector: It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.

Use of Artificial Intelligence (AI): We may use Artificial Intelligence (AI) to support parts of our hiring process, including sourcing, screening, and evaluating candidates. AI helps assess applications and qualifications, but final decisions are made by our hiring team. By applying, you acknowledge and agree that your application may be reviewed using AI tools.