Job Title: Quality EngineerJob DescriptionThe Quality Engineer plays a key role in ensuring that medical device products and processes comply with FDA 21 CFR 820, ISO standards, and international medical device regulations. This position focuses on managing quality systems activities, including sterilization qualification, CAPA management, validation review, and maintaining documentation needed for audits. The role requires strong organizational skills, attention to detail, and the ability to drive quality improvements across the organization.
Responsibilities
- Ensure compliance with FDA 21 CFR 820, Quality System Regulations (QSR), Good Manufacturing Practices (GMP), ISO standards, and international medical device regulations (including MDR) in assigned areas.
- Understand and support sterilization qualification and ongoing maintenance activities as they relate to medical devices.
- Manage the corrective and preventive action (CAPA) process from initial investigation through implementation and effectiveness checks.
- Maintain Design History Files and Technical Files, ensuring documentation is complete, accurate, and ready for internal and external audits.
- Organize and prioritize assigned tasks to ensure projects meet expectations, milestones, and timelines.
- Create, deliver, and maintain department and company training related to quality systems, procedures, and regulatory requirements.
- Review and approve verification and validation protocols and reports to ensure they meet regulatory and company standards.
- Utilize quality tools such as Failure Modes and Effects Analysis (FMEA), Control Plans, and Process Flow diagrams to support risk management and process improvement.
- Support and maintain the medical device Quality Management System (QMS), including ISO-related activities and documentation.
- Collaborate with cross-functional teams to resolve quality issues and implement sustainable corrective actions.
- Prepare for and participate in internal and external audits by providing required quality and regulatory documentation.
Essential Skills
- Relevant quality engineering work experience in an ISO-regulated medical device environment.
- Demonstrated experience reviewing verification and validation protocols and reports.
- Proven ability to manage CAPA processes from investigation through effectiveness checks.
- Experience supporting and maintaining medical device Quality Management System (QMS) activities.
- Knowledge of FDA 21 CFR 820, QSR, GMP, ISO standards, and international medical device regulations (including MDR).
- Understanding of sterilization qualification and maintenance for medical devices.
- Proficiency with quality tools such as FMEA, Control Plans, and Process Flow diagrams.
- Bachelors degree in Engineering or a related field of study.
- Proficiency in Microsoft Excel, Word, and other common office software.
- Strong verbal and written communication skills in English.
- Ability to stand, sit, and work at a computer for normal periods.
Additional Skills & Qualifications
- Experience working within a laid-back, collaborative, and team-oriented environment.
- Ability to organize and prioritize multiple tasks to meet project deadlines.
- Comfort collaborating across departments to support training and continuous improvement initiatives.
- Strong attention to detail and commitment to maintaining accurate and audit-ready documentation.
Work EnvironmentThis is a fully onsite position, Monday through Friday, typically from 8:00 a.m. to 5:00 p.m., with some flexibility in hours depending on employee needs. The company culture is laid-back and family-like, with a tight-knit group that values collaboration and open communication. Leadership maintains an open-door policy and fosters a welcoming environment. The team regularly engages in fun activities outside of work, promoting strong relationships and a positive atmosphere. Work is primarily performed in an office setting, involving regular standing or sitting and working at a computer for normal periods, with standard business-casual attire appropriate for a professional environment. Job Type & LocationThis is a Contract to Hire position based out of Phillipsburg, NJ. Pay and BenefitsThe pay range for this position is $40.00 - $45.00/hr. 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.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) Job Type & LocationThis is a Contract to Hire position based out of Phillipsburg, NJ. Application DeadlineThis position is anticipated to close on Nov 20, 2026. Workplace TypeThis is a fully onsite position in Phillipsburg,NJ.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 20,000 consultants and 5,000 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. We are proud to be an Engineering News-Record (ENR) Top 500 Design Firm for our engineering design services and a ClearlyRated Best of Staffing® winner for both client and talent service.
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.
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.