Job Description:
We are seeking a seasoned Quality Engineer to provide technical leadership and support to various teams within the organization. The successful candidate will be responsible for managing quality engineering projects, ensuring compliance with relevant procedures, and driving process improvements.
Key Responsibilities:
* Drive quality engineering projects and ensure they are managed in a structured fashion
* Manage project activities to ensure timely completion of project milestones
* Represent the team at key review meetings
* Work closely with other functions to build effective relationships
* Lead in the area of FDA, QSR, and ISO13485 requirements
* Identify and implement opportunities for improvement
* Maintain a proactive approach to developing the quality system
* Ensure that in-house or external quality issues are effectively prioritized and acted upon
* Demonstrate proven experience and proficiency across functional areas
* Support internal audit, supplier audit, and regulatory audit programs
* Prepare, execute, and analyze quality engineering documentation
Required Skills and Qualifications:
* Third level qualification in Science, Engineering, or relevant technical discipline
* Proven knowledge and experience of working with ISO13485, ISO14971, EU Medical Device Regulation 2017/745, and the FDA QSR
* Excellent communication and interpersonal skills
* Proven track record of pursuing continuous self-improvement
* Good working knowledge of Microsoft Office
* Proven problem-solving skills
* Taken lead in technical negotiations
Benefits:
* Competitive salary
* Ongoing training and development opportunities
* A supportive and collaborative work environment
Others:
* Travel may be required on company business
Keyword: QualityEngineer