Job Title:
Quality Assurance Specialist
About the Role:
We are seeking a Quality Assurance Specialist to support our development and manufacturing efforts. As a key member of our team, you will play a critical role in driving quality assurance activities that support product development, manufacturing, and regulatory compliance.
Key Responsibilities:
* Support and maintain the Quality Management System (QMS), ensuring compliance with ISO and FDA regulations.
* Assist in the execution and coordination of internal and supplier audits, including supplier performance monitoring and quality agreements.
* Lead investigations and root cause analyses for nonconformances (NCRs), customer complaints, and CAPAs, ensuring timely resolution and documentation.
* Develop, review, and approve quality documentation including validation protocols, reports, and manufacturing process controls such as PFMEAs.
* Collaborate with manufacturing and operations teams to support lot release activities, including sterilization validation and routine quality checks.
* Participate in management reviews, quality review meetings, and data analysis to provide actionable insights for continuous improvement.
* Provide quality input and support to internal projects and product lifecycle activities.
* Liaise with external auditors and regulatory bodies during inspections and audits.
* Facilitate communication of quality requirements across functional teams to ensure awareness and compliance.
* Support updates to the QMS in response to evolving regulatory or business needs.
Qualifications & Experience:
* Bachelor's degree in a scientific or engineering discipline.
* 5+ years of quality engineering experience in the medical device or pharmaceutical industry.
* Solid understanding of ISO and FDA QSR (21 CFR) and regulatory requirements for medical devices.
* Strong problem-solving skills with experience in CAPA, NCR, risk management, and root cause analysis.
* Experience working with suppliers and subcontractors on quality oversight activities.
* Excellent written and verbal communication skills, able to collaborate effectively with cross-functional teams.
* Demonstrated ability to work independently in a fast-paced, evolving startup environment.