Director Manufacturing Quality

Director Manufacturing Quality

As a Quality Leader for the factory in Pune, you will lead the efforts to establish and maintain the Quality Management System that manufactures, service and repair systems & devices for the business units of MR, IGT and US.

As Leader of the Manufacturing Quality team, you will make sure that every (sub) system and device manufactured and serviced and repaired is compliant with all applicable regulations and in line with the Quality Management System. You are responsible for maintaining the QMS and all the process, product certifications, audits and inspections.

On top of that you will drive continuous improvement, on process and on systems and devices.

Your role:

• Ensuring all systems and components are manufactured in a compliant way and meet all the required specifications.
• Maintaining the Quality Management System.
• Acting as Site Management Representative in external and internal QMS audits and inspections.
• Leading the Quality team in the Pune factory.
• Being part of the local Management team in Pune, representing manufacturing quality.
• Participating in and driving daily management to ensure that targets are met in the areas of Compliance and Quality.
• Realizing quality and compliance targets
• Being responsible for Production and Process controls
• Overseeing/ managing Process validation and process FMEA.
• Being accountable for CAPA and NC process, including managing non-conforming material and CAPA records.

You're the right fit if:

• A Masters or Bachelor’s Degree in Engineering, Science or other technical field
• A minimum of 15 years of experience in the Medical Device / Pharma field and specifically familiar with Class II and experience in quality management.
• A minimum of 5 years of experience in Leadership role
• A minimum of 5 years of experience in a manufacturing environment.
• Demonstrated knowledge of 21 CFR part 820 and ISO 13485
• Experienced in establishing strategy and keeping oversight
• Strong communication, interpersonal and stakeholder management skills
• Excellent organizational skills
• Assertive mindset: can-do mentality
• Ability to demonstrate high performance behavior of shared accountability, self-growth and grow others in order to improve processes and systems

About Philips
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If you’re interested in this role and have many, but not all, of the experiences needed, we encourage you to apply. You may still be the right candidate for this or other opportunities at Philips. Learn more about our commitment to diversity and inclusion here.

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