Quality Engineer
Quality Engineer
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Salary Not Disclosed
1 Vacancy
Job Description
Sr. Quality Engineer will lead a project focused on improving the quality and compliance of the Dispensing Implementation process. This role involves collaborating with the Dispensing Implementation teams to identify document and implement compliancerelated improvements ensuring the process aligns with regulatory standards and can pass an external regulatory inspection.
Responsibilities:
- Evaluate the Dispensing Implementation process against regulatory requirements such as CFR 820.200 and international standards.
- Lead a crossfunctional team to develop and execute a plan to enhance the processs compliance.
- Communicate weekly progress updates to Quality and SDS leadership teams.
- Ensure compliance with all service record documentation requirements.
- Adhere to Client Inspire Quality Processes and drive effective installation and implementation .
- Strong knowledge of quality engineering principles policies and best practices.
- Expertise in regulatory requirements including 21 CFR 210 211 ISO 13485 and ISO 14971.
- 10 years of experience in a Quality role within FDAregulated environments.
- Proven track record in quality/compliance improvement projects in FDAregulated environments.
- Experience with medical device installation especially with embedded software is strongly preferred.
- Strong attention to detail organizational skills and the ability to manage multiple tasks efficiently.
- Excellent communication and interpersonal skills with the ability to work collaboratively across teams.
- Proficiency in Excel Word and general business systems.
- Quality Engineering Certification (e.g. ASQ) is preferred.
Employment Type
Full Time
