Quality Assurance Engineer

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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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Location:
West Chester, PA, United States
Category:
Computer And Mathematical Occupations

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