NextPhase Medical Devices LLC is a fast-growing, engineering design and contract manufacturer of single-use and electromechanical medical devices, with facilities in Rochester, NH, Mansfield, MA, and Tijuana, Mexico.
Based in our Rochester, NH facility, the Quality Engineer supports the Quality Management System (QMS) to ensure compliance with the regulatory and procedural requirements in the manufacture of single-use disposable medical products for NextPhase’s customers. The Quality Engineer will assist the assigned Value Stream Business Unit in the establishment and implementation of programs designed to assure control of processes and products toward the established standards of quality under NextPhase’s QMS.
Responsibilities:
- Understand and ensure compliance with the ISO 13485:2016, 21 CFR Section 820, MDD, and NextPhase Quality System 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.
- As the Quality technical lead of a Value Stream Team, 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.
- Develops 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.
Other Duties:
Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice.
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 the 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 communication skills.
- Competent in Microsoft Office Suite, including Word, Excel, Power Point, and Visio.
- Good presentation and training skills.
Education, Certification, and Experience:
- 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.
Physical Demands:
- Ability to lift 40 pounds.
- Sitting and working on a computer for extended periods.