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Quality Engineer II
Industry specialist
Tommy McKeown
Senior Recruiter
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Permanent
Quality Engineer II
Responsibilities:
Qualifications:
Responsibilities:
- Ensure compliance with customer and regulatory quality systems (ISO 13485, FDA).
- Develop and maintain effective inspection plans for incoming, in-process, and final products.
- Investigate and resolve quality issues, including customer complaints, using CAPA systems.
- Assess product/process changes for validation and quality impacts.
- Manage product dispositions and update specifications/documentation as needed.
- Write validation protocols, reports, and test documentation.
- Lead quality audits (internal, supplier, customer, and regulatory).
- Support continuous improvement using process data and Lean/Six Sigma methodologies.
- Supervise and mentor a team of up to 4 staff.
- Collaborate with customers and suppliers on quality matters and new product launches.
- Adhere to safety, health, environmental, and energy management standards.
- Perform additional duties as assigned.
Qualifications:
- Degree/Diploma in Engineering, Science, or Quality, with 5+ years of experience in the medical device industry.
- Strong regulatory knowledge (ISO 13485, FDA).
- Six Sigma Green Belt (or higher); Lean Green Belt preferred.
- Proven leadership, problem-solving, and communication skills.
- Self-motivated with the ability to work independently.