Senior Quality Engineer
Senior Quality Engineer
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Not Disclosed
Salary Not Disclosed
1 Vacancy
Job Description
Responsibilities:
- Evaluate and improve contract manufacturers processes through research design and collaboration.
- Develop and optimize manufacturing processes and equipment in partnership with vendors.
- Onboard and manage contract manufacturers ensuring regulatory compliance.
- Enhance manufacturing efficiency through workflow and layout analysis.
- Design and implement testing methods to ensure product and process quality.
- Serve as a key resource for manufacturing and quality-related inquiries.
- Ensure compliance with regulatory standards to maintain product reputation.
- Support design and development projects including training contract manufacturers.
- Maintain quality engineering functions such as supplier controls audits and validations.
- Participate in Material Review Board and CAPA processes to address non-conformances.
- Provide design control support for new product development including risk management.
- Drive continuous improvement of the Quality Management System (QMS).
- Conduct internal and supplier quality audits.
- Create and maintain documentation for product specifications validations and design history files.
- Support QMS functions such as document control training and device history record management.
Requirements:
- Bachelors degree in engineering or a related technical field or equivalent experience.
- 6-8 years of experience in manufacturing and supplier quality engineering.
- Experience with process validations and contract manufacturer management.
- Background in medical devices and FDA-regulated industries.
- Strong knowledge of ISO 13485 standards.
- Excellent communication organizational and project management skills.
- Proficiency in Microsoft Office (Outlook Word Excel PowerPoint).
- Strong analytical and problem-solving abilities with a proactive mindset.
Additional Information :
All your information will be kept confidential according to EEO guidelines.
Remote Work :
No
Employment Type :
Contract
Employment Type
Contract
