78 applicants
Sequel Med Tech · 3 days ago
Quality Engineer
Manchester, NH
Full-time
Hybrid
Entry, Mid Level
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Responsibilities
Assist with activities related to controlled documents in the quality management system including document creation, obsolescence, archival, and revisions.
Review documents for accuracy, completeness, and compliance in accordance with relevant regulations (e.g., ISO 13485, FDA CFR 820).
Contribute to supporting the Document Control Manager with implementing Sequel's QMS, MLR process review and approvals, and document control system implementation.
Support and drive advanced data analysis techniques and reporting tools.
Provide day-to-day support for Document and Change Control in the electronic QMS.
Assist with internal and external audits. Coordinate/track/drive closure of QMS audit report responses, CAPAs, deviations. Ensure closure and implementation in a timely manner.
Support Nonconformance (NCMR) process such as inspection methods, containment, correction, closure and CAPAs, and drive continuous improvement through analysis of trend data.
Support analysis of defective components found in Incoming Inspection and work with suppliers to resolve through the SCAR process.
Compile and present quality issues and KPI to cross functional teams in a concise and clear manner.
Work independently and within teams.
Travel required up to 20% including some international.
Qualification
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Required
Bachelor's degree in a STEM area.
Experience as a QE in a medical device manufacturing company.
Project management tracking and trending experience.
Deep understanding of FDA GMP principles and ISO 13485 requirements
Experienced in the development and execution of validation activities for manufacturing and software.
Experienced in building out elements of a QMS system, including creating quality plans, developing and releasing SOP’s, training and process mentoring.
Experienced in the use of data analytics development tools such as Power BI or others.
Firmly understands the best practices for driving effective corrective and preventive actions and can mentor others in that process.
Six Sigma experience
Lean manufacturing experience
Advanced statistical data analysis skills
Ability to manage multiple projects and tasks with ease
Preferred
Veeva Vault, Veeva Learning, Veeva QMS, Veeva PromoMats preferred.
Internal/External auditing experience preferred.
Company
Sequel Med Tech
We’re Sequel — a driven team of innovators and problem solvers laser-focused on improving the health and lives of people with diabetes.
Founded in 2023
11-50 employees
Funding
Current Stage
Early StageCompany data provided by crunchbase
