Senior Supplier Quality Engineer

ApiJect is seeking a Senior Supplier Quality Engineer to support the development and maintenance of quality systems programs, policies, processes, procedures, and controls ensuring that performance and quality of the Quality Management System complies with regulation, standards and agency guidelines. This position will configure and manage the electronic Quality Management System (eQMS).

• Extensive knowledge of device regulations including but not limited to, Design Controls, Risk Management, Product Transfer to Manufacturing, Production & Process Controls, Audit Management, and Supplier Management as it relates to the execution of an efficient QMS.
• Manage supplier qualification and maintenance program, supplier changes and evaluate associated risk to product and QMS.
• Ability to prepare reports, analyze and summarize data using statistical analysis for metrics reporting.
• Must have extensive background working with Contract Manufacturing Organizations.
• Maintain relationships with suppliers and maintain the Approved Supplier List (ASL).
• Manage Quality Agreements and Master Supply Agreements and ensure adherence to requirements.
• Manage Supplier Corrective Action Report (SCAR) program, review SCAR responses for acceptability.
• Manage Audit program (internal and supplier).
• Required Quality experience in combination regulated devices/combination products and/medical devices at all stages of the product life cycle.
• Demonstrated ability to problem solve with a deep understanding of regulated devices.
• Ability to work cross functionally and gain support of other functions in alignment with corporate goals.
• Effectively communicate with vendors and associates at all levels of the organization.
• Strong written and oral communication skills.

Please refer the Job description for details