Job Description
Quality Engineer sought for medical device manufacturing environment. Develop quality assurance procedures, control materials and finished goods, and ensure quality standards are met.
Key Responsibilities:
Develop and implement quality assurance procedures and methods for control of materials and finished goods.
Work with suppliers to ensure quality standards are met and maintained.
Develop and execute product quality control plans, documents, and procedures.
Provide input to risk analyses and Process Failure Mode Effect Analysis (p FMEAs) including with suppliers.
Implement and enhance quality principles, gather and analyze quality data to support product/process improvement activities.
Oversee manufacturing-related quality events in line with GMP and internal procedures.
Disposition non-conforming material and work with manufacturers and suppliers to implement corrective and preventive actions.
Provide quality guidance as an integral member of the operations team.
Provide quality input into process validation activities.
Requirements:
BE/BS Degree.
A Post-graduate qualification in Quality Assurance is preferable although not mandatory.
At least three years Quality Engineering experience or related role within the medical device industry.
Experienced working in a medical device manufacturing environment complying with Good Manufacturing Practices.
Comprehensive benefits package and opportunities for growth and development available to successful candidate.