Supplier Quality Engineer, Medical Device

Job Description

We are seeking a highly skilled Supplier Quality Engineer to join our team. This position is based in our Rochester, NH NextPhase Medical facility.

About Arterex

Arterex is a multi-capability medical device contract manufacturing platform resulting from the combination of Kabo, Formula Plastics, Luc & Bel, ModenPlast, and NextPhase. The company serves a wide range of customers, from leading global medical and healthcare OEMs to smaller regional specialty customers primarily in the United States and Europe. Arterex has a global manufacturing footprint with 7 state-of-the-art facilities across the US, Mexico, Italy, and Egypt. Additional information is available at

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 assure control of processes and products toward the established standards of quality under NextPhase’s QMS.

Other responsibilities include:

Understand and ensure compliance to the ISO 13485:2016, 21 CFR Section 820, 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.

Support the NextPhase Supplier Change Request (SCR) process. This will require assessing the impact of the change and collaborating with the supplier and the customer on the qualification steps required.

Work with NPI Engineering and Manufacturing Engineering to develop validation strategy for supplier changes in collaboration with the customer. This includes the approval of supplier validation protocol and reports along with development of incoming inspection requirements needed to qualify the change.

Manage customer deliverables and quality documents as they relate to supplier changes or quality issues.

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.

Work with purchasing and operations to address nonconforming supplier components and sub-assemblies.

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.

Required Skills, Knowledge 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

Comprehensive understanding of ISO 13485:2016 and FDA Quality System Regulations (QSR)

under 21CFR 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

Understanding of Purchasing/Supplier Controls for medical device manufacturing, especially as it relates to supplier change processes and related controls.

Ability to analyze and interpret data utilizing Minitab or other software tool.

Job Type: Full-time

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 FridayCompany Description

At NextPhase, we’re solely focused on medical device design, development, and manufacturing. As your outsourcing solutions partner for all low- to medium-volume complex electromechanical and single-use devices, you can count on high-quality, superior service, and continuous improvement throughout your entire product life-cycle. We offer a full suite of services across a comprehensive range, including concept ideation, feasibility analysis, design, development, LEAN-focused manufacturing, assembly, and aftermarket services, sterilization, & sterilization management. Additionally, our geographic presence enables us to use best medical device manufacturing practices for complex medical devices. Based in North America, NextPhase has locations in Rochester, NH and Mansfield, MA as well as in Tijuana, Mexico.

We recognize that as a medical device manufacturer the work we do has a significant and meaningful impact on patients’ lives. The core values that we’ve established and operate by allow us to empower our employees to deliver the best medical device solutions and enable them to improve the quality of life of patients.

We are proud and honored to be able to provide our customers with medical device solutions that help improve patient lives.