Quality Specialist

Job Title: Quality Assurance Specialist

Job Description

This role supports Operations and Quality by ensuring compliance with regulatory requirements and driving continuous process improvements within a medical device environment. The Quality Assurance Specialist partners closely with the Quality team to respond to quality events, enhance processes, and maintain robust quality system standards that align with FDA regulations and cGMP requirements.

Responsibilities

• Support Operations and Quality teams in maintaining compliance with applicable regulatory requirements and internal quality system standards.
• Collaborate closely with Quality personnel to investigate and respond to quality events, ensuring timely and effective resolution.
• Drive process improvements across operations and quality functions to enhance efficiency, consistency, and product quality.
• Contribute to the development, implementation, and maintenance of quality system documentation and procedures.
• Perform document control activities, including creating, reviewing, updating, and managing controlled documents in accordance with established protocols.
• Support CAPA (Corrective and Preventive Action) processes by assisting with root cause analysis, action plan development, implementation, and effectiveness verification.
• Ensure adherence to FDA regulations and cGMP standards in daily activities and across operational processes.
• Maintain accurate, complete, and compliant documentation for quality events, CAPA activities, and process improvements.
• Analyze quality data and documentation to identify trends, issues, and opportunities for improvement.
• Partner with cross-functional teams to promote a culture of quality and continuous improvement throughout the site.

Essential Skills

• Quality assurance experience in a regulated environment.
• Hands-on experience working with FDA regulations.
• Experience in the medical device industry.
• Knowledge of CAPA (Corrective and Preventive Action) processes.
• Experience with document control practices and systems.
• Understanding of cGMP (current Good Manufacturing Practices) requirements.
• Bachelor's degree in Life Sciences or a technical field.
• Strong documentation skills with high attention to detail.
• Strong analytical skills to interpret data and identify trends and root causes.

Additional Skills & Qualifications

• Ability to collaborate effectively with Operations and Quality teams.
• Ability to manage multiple tasks and priorities in a dynamic environment.
• Strong written and verbal communication skills for clear documentation and cross-functional interaction.
• Continuous improvement mindset with an interest in optimizing processes.
• Comfort working in a small-site environment and contributing across multiple quality activities.

Work Environment

This is an on-site, first-shift position working Monday through Friday at a facility with approximately 50 employees. The environment is a small, collaborative site where Quality and Operations work closely together. Work is performed in a professional, regulated setting that follows FDA and cGMP standards, with a focus on medical device quality systems and documentation. Standard professional attire is expected, and employees work in office and controlled production or laboratory areas as needed to support quality assurance activities.

Job Type & Location

This is a Contract position based out of New Cumberland, PA.

Pay and Benefits

The pay range for this position is $25.00 - $35.00/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 New Cumberland,PA.

Application Deadline

This position is anticipated to close on Jul 15, 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 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.