Quality Manager

Job Title
Quality Manager

Job Description

Job title:
Quality Manager

Your role:

Transform Business long-range quality and compliance policies to projects and deliverables. Lead cross functional activities and projects in Quality. Implement Continuous Improvement in such a way as to ensure that the Business strategy and strategic growth targets are met.

Responsibilities:

Lead the development and implementation of quality practices for the effective and efficient development, transfer, and maintenance of products/processes throughout the product lifecycle.
Lead quality improvements implementation as appropriate to legacy products, continuous improvement, and customer satisfaction.
Responsible for development, maintenance and continuous improvement of Quality KPIs.
Receive assignments in the form of strategic objectives and determine how to use resources to meet schedules and goals. Tracks assignments status, quality and report-out to management
Manage and monitor E2E Potential Safety events and field escalations investigation and assessment processes (IIA/HHE and C&R) with cross functional team.
Manage and Monitor Quality Transitions plans and activities.
Handling external audits by notified body, auditing organizations and regulatory authorities
Plan and manage implementation of internal quality audits and related findings
Overview of training planning and effectiveness
Interact with all areas of the business, such as R&D, customer services, sales, marketing, post-market, etc. to provide direction and consultation
Formulate and recommend (changes to) policies and established procedures that affect immediate organization(s) activity, either directly or through Q&R functions
Often must lead a cooperative effort among members of a quality functions team

You're the right fit if:

At least 5 years of experience in QA/QMS management at Medical Device company
Proven experience in establishment and / or management of quality systems in compliance with ISO 13485, preferably for a multi-disciplinary product
Proven experience in leading MDSAP / ISO 13485 audits/ FDA-QSR Inspections
Understanding of Post Market surveillance activities
Academic graduates in the field of Engineering or Life Sciences
Great communication and influential skills, Supportive and service oriented, Team Player
Fluent verbal and written English
Eager and capable to learn and be self-taught
CQE / CQA / PMP – advantage

About Philips
We are a health technology company. We built our entire company around the belief that every human matters, and we won't stop until everybody everywhere has access to the quality healthcare that we all deserve. Do the work of your life to help the lives of others.
• Learn more about our business.
• Discover our rich and exciting history.
• Learn more about our purpose.

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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