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
  
  

• 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
  
  

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