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- 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).
- As a Documentation Control team member will 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.
- Support FMEA and Risk Analysis
- 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.
- Bachelor's degree in a STEM area or equivalent experience.
- Experience as a QE in a medical device manufacturing company.
- Project management tracking and trending experience.
- Veeva Vault, Veeva Learning, Veeva QMS, Veeva PromoMats preferred.
- Deep understanding of FDA GMP principles and ISO 13485 requirements
- Experienced in the development and execution of validation activities for manufacturing and software. Design verification and validation is a plus.
- 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.
- Ensures environmental consciousness and safe practices are exhibited in decisions
- Use of computer and telephone equipment and other related office accessories/devices to complete assignments
- May work extended hours during peak business cycles
Quality Engineer - Manchester, United States - Sequel Medical Technology
Description
Job Description
Job DescriptionAbout SequelSequel Med Tech is an emerging medical device company committed to revolutionizing patient care through innovative solutions. Our mission is to improve the lives of patients by developing cutting-edge medical technologies that address unmet needs in healthcare.
Job Overview
The Quality Engineer will be a key member of our growing Quality/Regulatory team as we build out a robust QMS compliant with FDA and EU regulations. The QE will first contribute in areas immediately being phased in, including document control system implementation, and Market, Legal and Review documentation and approvals. Longer-term phase-in will include responsibilities in all areas of QA and Regulatory activities as we build out our systems.
Job Responsibilities and Essential Duties
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