NextPhase Medical Devices LLC is a fast growing, contract manufacturer of single- use disposable medical devices. Headquartered in Rochester, NH, we also have manufacturing facilities in Mansfield, MA and Tijuana, Mexico. The Quality Engineer position is based in our Rochester, NH facility and reports directly to the VP, Engineering and Quality.
This is a full-time on-site role for a Quality Engineer located in the Rochester, NH facility and reports directly into the Director of Quality Assurance. The Quality Engineer is responsible for managing all technical activities for internal and external customer projects involving complex disposable medical products. The Quality Engineer works as part of a Value Stream Team to ensure product quality and adherence to the Quality Management System is maintained and supports the Quality Management System (QMS) to ensure compliance to the regulatory and procedural requirements in the manufacture of disposable medical products for NextPhase’s customers.
Other responsibilities include:
- Understand and ensure compliance to ISO 13485:2016, 21 CFR Section 820 MDD and NextPhase Quality Systems Requirements
- Act as the NextPhase quality interface for assigned customers and suppliers.
- Monitor customer complaints and trends. Respond as needed for failure investigation and specific corrective actions.
- Provide quality support to existing product/process issues, including NCMR’s, MRB, root cause analysis, Deviations, test procedures and protocols.
- Conducts risk analysis for products and processes being transferred, following guidance under ISO 14971.
- Create Quality Plans and Master Validation Plans in support of customer product implementation.
- Develop verification and validation protocols supporting the implementation of products and processes into NextPhase’s clean room production environment.
- Manage customer deliverables and quality documents to an approved/released state.
- Active participant in customer business reviews, presenting key performance metrics.
- Supports audits performed by Notified Body and customers. Will perform/participate in audits of NextPhase suppliers as required.
- Investigation and correction of internal, customer, and supplier quality issues.
- Coordinate efforts with Engineering and Manufacturing for the establishment of controls, which support current product designs, and process capabilities for assigned product lines.
- Lead product, process and component root cause failure analysis with Engineering counterpart.
- Drive the CAPA process to completion on assigned corrective and preventive actions.
- Evaluation and approval of proposed changes to the NXP Quality Management System, validations, and deviations.
Required Skills, Knowledge and Experience:
- Comprehensive understanding of ISO 13485:2016 and FDA Quality System Regulations (QSR) under 21CFR Sec. 820 as they pertain to the production of medical devices.
- EEC Medical Device Directives and any necessary product specific applicable standards
- Complete understanding of ISO 14971 Risk and Hazard Assessment
- Strong statistical analysis skills with ability to analyze and interpret data utilizing Minitab software.
- Ability to conduct Root Cause Analysis using Fishbone Diagrams and/or Fault Tree Analysis.
- Must possess strong written and verbal communications skills.
- Competent in Microsoft Office Suite, including Word, Excel, Power Point and Visio.
- Good presentation and training skills
- BS in engineering, biology or related science.
- 2-5 years of medical device manufacturing experience as a Quality Engineer.
- Certificate in one or both preferred: CQE, CQA
Job Type: Full-time
Pay: $80,000.00 - $115,000.00 per year
Benefits:
- 401(k)
- 401(k) matching
- Dental insurance
- Flexible spending account
- Health insurance
- Health savings account
- Life insurance
- Paid time off
- Vision insurance
Schedule:
- 8 hour shift
- Day shift
- Monday to Friday
Application Question(s):
- Are you located within 100 miles of Rochester, NH?
Ability to Commute:
- Rochester, NH 03867 (Required)
Work Location: In person