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 either our Rochester, NH facility or Mansfield, MA facility, the Supplier Quality Engineer supports the Quality Management System (QMS) to ensure compliance to the regulatory and procedural requirements in the manufacture of medical products for NextPhase’s customers. They will assist the assigned Value Stream Business Unit in the establishment and implementation of Supplier Quality programs designed to ensure 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/MDR, IVDR, and NextPhase Quality System requirements
- Act as the NextPhase quality interface for assigned customers and suppliers.
- Collaborate with supply chain function to complete supplier assessments and scorecards.
- Develops validation strategy for supplier changes in collaboration with the customer. This includes the approval of supplier validation protocol and reports along with the development of incoming inspection requirements needed to qualify the change.
- Support internal validation activities, as needed.
- Manage customer deliverables and quality documents as they relate to supplier changes or quality issues.
- Interface with customers to drive improvements or changes with suppliers.
- Active participant in the Quality Management Review process by presenting key supplier performance metrics.
- Conduct Supplier Quality Audits to support Quality system requirements and “for-cause” audits to address specific supplier issues.
- Support the Investigation and correction of internal quality issues to assess the potential impact of supplier(s).
- Work with purchasing and operations to address nonconforming supplier components and sub[1]
- Lead root cause failure analysis of supplied components with Engineering counterpart.
- Drive the Supplier CAPA process to completion on assigned corrective and preventive actions.
- Evaluation and approval of proposed changes to the NXP Supplier Quality Management Systems and processes.
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.
- Ability to interpret engineering drawings and specifications as they relate to components as well as integrated assemblies.
- Complete understanding of Purchasing/Supplier Controls for medical device manufacturing.
- Strong statistical analysis skills with the ability to analyze and interpret data utilizing Minitab or other software tools.
- Ability to conduct Root Cause Analysis to address supplier-related quality problems.
- 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.
Location:
- The primary Location is either Mansfield, MA or Rochester NH with some travel to other NextPhase sites, as required.
- Periodic travel to suppliers will be required on an as-needed basis.