Senior Quality Manager

7 days ago

Dasmariñas, Calabarzon, Philippines beBeeQuality Full time $75,000 - $100,000
Job Title

We are seeking a seasoned Quality Management Specialist to lead our quality management processes and team. This individual will champion quality within the organisation, ensuring that our corporate mission is fulfilled.

The Quality Management Specialist will be responsible for monitoring, maintaining and improving our purpose-built Quality Management System in accordance with ISO 13485 and ISO 9001 standards.

Audit programs and plans will be developed and internal audits coordinated with external audits. Opportunities for improvement in company processes and systems will be identified, planned and documented.

Collaboration with subject matter experts will be critical in driving implementation of best practices.

Managing CAPA related activities, identifying and advising on relevant standards and regulation for product developments, and maintaining up-to-date libraries of applicable standards and regulation across global markets are essential duties.

Facilitating company and product development risk management in accordance with best practices is necessary. Appropriate identification and records of product user needs, requirements verification and validation activities and traceability throughout development must be managed.

Quality for medical device development is managed according to regulation such as CE MDR, FDA and TGA and standards including ISO 13485, IEC 60601 and IEC 62304.

Calibration of test and measurement equipment is also managed. Selecting and evaluating suppliers, monitoring quality agreements, and managing actions arising from goods inspection are key tasks.

Developing and conducting induction and training on QMS processes and policies, and promoting QMS regulatory requirements to all staff is an important responsibility.

Required skills and qualifications include a relevant qualification from a reputable education organisation and at least 5 years' experience in quality management or a similar role.

In-depth knowledge of ISO 13485 and ISO 9001, as well as regulatory requirements pertaining to product development is essential.

Understanding of a variety of production/manufacturing processes is also required.

Excellent verbal and written English communication skills, ability to work independently and as part of a team are preferred skills and experiences.

Quality management experience in product design and development is also preferred.

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