Job Title: Quality Assurance Engineer
 

Job Overview:
We are seeking a detail-oriented and proactive Quality Assurance Engineer to support quality operations within a regulated medical device environment. This hybrid, permanent/direct-hire position based in West Chester, PA, is responsible for ensuring compliance with quality system regulations, supporting product and process investigations, and contributing to continuous improvement initiatives that uphold patient safety and regulatory standards.
 

Compensation:
• $90,000 – $100,000 annually, plus bonus opportunities
 

Work Schedule:
• Hybrid: 2–3 days onsite per week
 

Key Responsibilities of the Quality Assurance Engineer:
• Manage intake, investigation, and documentation of product complaints and support closure activities
• Maintain compliance with applicable standards and regulations (e.g., ISO 13485, MDR, QSR)
• Prepare and submit adverse event reports to appropriate regulatory bodies when required
• Lead or support corrective and preventive actions (CAPAs), including root cause analysis and effectiveness checks
• Monitor and report on quality system metrics and trends
• Review training records and verify documentation compliance
• Support product development and design transfer activities to ensure quality requirements are met
• Assist in the development and revision of quality system documentation
• Participate in internal and external audits, including those from regulatory agencies and notified bodies
• Contribute to risk management activities such as FMEAs and hazard analyses
• Provide documentation and support for regulatory submissions or distributor requests
• Assist with field actions or recall documentation when applicable
• Support cross-functional quality initiatives and process improvements
 

Qualifications and Skills for the Quality Assurance Engineer:
• Bachelor’s degree in Engineering, Life Sciences, or a related field (or equivalent work experience)
• 2–3 years of quality assurance experience in a regulated medical device or life sciences environment
• Working knowledge of ISO 13485 and other applicable regulations (e.g., MDR, FDA QSR)
• Experience in complaint handling and CAPA processes preferred
• Proficiency in Microsoft Office; experience with quality system software tools is a plus
• Strong communication, analytical, and organizational skills
• Ability to work independently while collaborating across departments
 

Why Join Us?
This is a fantastic opportunity to make a meaningful impact in a growing organization committed to patient safety and product quality. You’ll work alongside a dedicated team of professionals and contribute to products that improve lives.
 

About Us:
Contemporary Staffing Solutions (CSS) is a trusted leader in providing contract, temporary, temp-to-hire, and direct hire staffing solutions. With decades of experience, we’ve grown from a staffing agency to a nationwide provider of workforce management solutions. Our niche recruitment expertise spans Accounting & Finance, Call Center & Office Support, Human Resources, Sales & Marketing, and Information Technology.
Explore more about CSS and how we connect great talent with exceptional opportunities by visiting www.ContemporaryStaffing.com.

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