Quality Engineer II
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