Quality Engineer II
A forward-thinking Medical Device company is seeking a skilled Quality Engineer II to join their team.
About the Role
* Lead and manage root cause investigations, ensuring timely and effective corrective and preventive actions (CAPA).
* Manage the day-to-day activities of the Quality Management System (QMS), ensuring compliance with ISO 13485 and regulatory requirements.
* Conduct and support internal audits, driving continuous improvement and adherence to quality standards.
* SUPPORT AND OVERSEE VALIDATION ACTIVITIES INCLUDING PROCESS VALIDATION TEST METHOD VALIDATION AND RISK ASSESSMENTS.
* Provide quality support for manufacturing operations, ensuring product compliance process control and efficiency.
* Develop implement and maintain Standard Operating Procedures (SOPs) and work instructions to support quality initiatives.
* Serve as primary quality contact for customer quality concerns complaints and regulatory inquiries leading investigation processes as required.
* Identify and implement continuous improvement initiatives to drive efficiency and enhance product quality.
* Mentor and guide junior quality team members supporting their professional development.
* Assist in supplier quality management ensuring robust quality agreements and compliance with regulatory standards.
Requirements
* Bachelor's degree in Engineering Quality Life Sciences or a related discipline.
* 3+ years of experience in a medical device or regulated manufacturing environment.
* Strong expertise in root cause analysis CAPA management and failure investigations.
* ISO 13485 lead auditor training certification preferred but not required.
* Proven experience in internal auditing and regulatory compliance.
* Strong knowledge of quality engineering principles including FMEA SPC risk management and validation processes.
* Excellent problem-solving abilities and a data-driven approach to decision-making.
* Strong interpersonal communication and leadership skills with the ability to collaborate across departments.
* Proficiency in Microsoft Office Suite and quality management software.