Supplier Quality Engineer

Description:

The Supplier Quality Engineer role works with external suppliers and cross-functional teams on a daily basis to resolve supplier related issues, lead supplier activities within projects, drive continuous improvement while driving key quality metrics across the Supplier Quality Team. Other activities may be assigned as needed.

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What are the key responsibilities?

• Manage and led all process validation activities including IQ, OQ and PQ with existing and new Suppliers.

• Ensure effective and timely closure of Quality System documentation (Audit Actions, SCAR’s, SCN’s, PAN’s, etc.).

• Lead Quality Engineering support at Aerogen on project activities i.e.: Design Improvements, Supplier Transfer’s, Cost Improvements, and New Product Introductions etc.

• Lead Supplier Approval and Supplier Management Activities for allocated Suppliers to ensure Aerogen Supplier Approval Requirements are met.

• Work with Manufacturing Quality to establish inspection plans, frequencies, and test methods for incoming material/parts.

• Champion continuous process improvement and, in conjunction with other functions, analyse feedback and identify and implement appropriate problem solving and statistical techniques to improve quality of manufactured product and overall effectiveness and efficiency of processes.

• Establish analysis techniques and other quality control tools within project activities as well as utilization of these to solve specific supplier quality problems.

• Overall responsibility for GMP standards and compliance within Aerogen’s Project Teams and Supplier Engagement.

• Maintain compliance with ISO and FDA Quality System regulations.

The role will also support external audits, internal audits and any relevant Quality/Regulatory compliance related activities as deemed necessary. The role will require a high degree of flexibility to coordinate the variety of tasks.

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What education and experience are required?

• BE/BS Degree. A Post-graduate qualification in Quality Assurance is preferable although not mandatory.

• At least four years Quality Engineering experience or related role within the medical device industry.

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