We are seeking a highly motivated Quality Engineer II to join our team at {company}. The successful candidate will be responsible for leading and managing root cause investigations, ensuring timely and effective corrective and preventive actions (CAPA).
The ideal candidate will take ownership of the day-to-day management of the Quality Management System (QMS), ensuring compliance with ISO 13485 and regulatory requirements.
Key responsibilities include conducting and supporting internal audits, continuous improvement, and adherence to quality standards. Additionally, the candidate will support and oversee validation activities, including process validation, test method validation, and risk assessments.
In this role, you will provide quality support for manufacturing operations, ensuring product compliance, process control, and efficiency. You will also develop, implement, and maintain Standard Operating Procedures (SOPs) and work instructions to support quality initiatives.
The primary quality contact for customer quality concerns, complaints, and regulatory inquiries, you will lead investigation processes as required. Your expertise in root cause analysis, CAPA management, and failure investigations will drive continuous improvement initiatives to enhance product quality.
To succeed in this role, you will need a Bachelor's degree in Engineering, Quality, Life Sciences, or a related discipline. A minimum of 3 years' experience in a medical device or regulated manufacturing environment is also required.
A strong background in ISO 13485 lead auditor training (certification preferred but not required) is essential. Proven experience in internal auditing and regulatory compliance is also necessary.
You will have excellent problem-solving abilities and a data-driven approach to decision-making. Strong interpersonal, communication, and leadership skills are also essential, with the ability to collaborate across departments.
Proficiency in Microsoft Office Suite and quality management software is required.
This is a fantastic opportunity to join a forward-thinking team and thrive in a collaborative, supportive environment that values creativity and teamwork.