Job Title: Senior Quality Engineer
We are seeking a seasoned quality professional to provide expert engineering support in quality assurance, control, and preventative activities with a focus on continuous improvement of internal products and processes.
The ideal candidate will be responsible for supporting supplier quality issues impacting daily operations and advocating for initiatives and projects to enhance quality performance within the business and for our customers.
The successful candidate will possess strong knowledge of quality concepts, including risk management, CAPA, audits, and statistics. They will also have excellent communication, project management, and influencing skills, with the ability to manage multiple tasks simultaneously.
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Key Responsibilities:
* Provide quality engineering support in quality assurance, control, and preventative activities
* Support supplier quality issues impacting daily operations
* Advocate for initiatives and projects to enhance quality performance
* Ensure compliance with regulations and standards
* Represent the Quality function within project teams
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Requirements:
* Previous industry experience desired
* Experience interacting with regulatory agencies (FDA, MoH, TUV, etc.) desired
* Understanding of US and International Medical Device Regulations
* Familiarity with ISO 13485, GDP, GMP desired
* Strong knowledge of Quality Concepts (e.g., Risk Management, CAPA, Audits, Statistics)
* Excellent communication, project management, and influencing skills
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Working Conditions:
* Computer literacy required
* Some travel may be required