28 Jobs in Manchester, NH
Sequel Medical Technology is Hiring a Quality Engineer Near Manchester, NH
- 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.
- 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
Job Summary
Full Time
$98k-116k (estimate)
03/12/2024
06/05/2024
The job skills required for Quality Engineer include Project Management, etc. Having related job skills and expertise will give you an advantage when applying to be a Quality Engineer. That makes you unique and can impact how much salary you can get paid. Below are job openings related to skills required by Quality Engineer. Select any job title you are interested in and start to search job requirements.
The following is the career advancement route for Quality Engineer positions, which can be used as a reference in future career path planning. As a Quality Engineer, it can be promoted into senior positions as a Quality Assurance Engineer IV that are expected to handle more key tasks, people in this role will get a higher salary paid than an ordinary Quality Engineer. You can explore the career advancement for a Quality Engineer below and select your interested title to get hiring information.
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