Senior Supplier Quality Engineer

Nextern•Maple Grove, MN

About The Position

This role is responsible for partnering with development, manufacturing, supply chain, and quality teams to assess, onboard, and qualify new material and component suppliers and monitor continued supplier performance. The supplier quality engineer is the primary liaison to Nextern suppliers to facilitate communication related to quality of supplied materials, change notifications, performance assessments/audits, and resulting actions as applicable. All engineering functions are responsible for compliance with the Quality System and relevant regulations and standards, continuous improvement, and as needed, professional interaction with Nextern Customers.

Requirements

Bachelor's Degree (BS) in life science discipline or equivalent combination of education and experience.
10+ years of experience in medical device Quality function, or 5+ years of experience in a Supplier Quality/Supplier Engineering role
Experience working in quality systems as defined in 21 CFR 820 and ISO 13485
BSI (or equivalent) ISO 13485 Lead Auditor certification
Understanding of ISO 14971 and application of risk management to supplier qualification
Demonstrated technical expertise and leadership in quality
High attention to detail, organization, and accuracy
Instinctual capability for creative thinking and proposing novel solutions
Strong ability to communicate (written and verbally) within and across disciplines and organization structures
Demonstrated use of quality tools and methodologies (e.g. nonconformance, CAPAs, root cause analysis, etc..)

Nice To Haves

Familiarity with statistical software, such as Minitab, preferred
Experience with Product Lifecycle Management (PLM) software (e.g Windchill, Agile, Propel)
Intermediate to advanced proficiency with MS Office Suit (Word, Excel, PowerPoint, Project, Outlook)

Responsibilities

Partners with development and supply chain teams to initiate new and monitor existing suppliers
Assess purchased material and supplier characteristics to determine supplier categorization
Initiate, populate, and maintain supplier files to ensure traceable supplier control
Ensure supplier and supplied part documentation meets business and program requirements
Receive, initiate, and assess supplier change notifications. Coordinate with SMEs as necessary
Initiate and assign ownership for Supplier Corrective Action Requests (SCARs)
Coordinate and execute, as applicable, material and component testing in support of material qualification
Define and establish monitoring requirements/plans for receiving inspection and supplier data
Compile, analyze, and present supplier specific performance metrics for project design and management reviews
Initiate, investigate, and coordinate SME support as necessary to process supplied part NCs & CAPAs
Owner of Quality System processes for supplier selection, qualification, and monitoring
Proactively identify redundancy and opportunities for efficiency in Quality System requirements
Review and approve changes for supplied parts to ensure adequate supplier data/linkage
Support external and internal audits as Subject Matter Expert (SME) for owned QMS processes
Plan and lead supplier audits and support supplier monitoring audits, as necessary
Other duties as assigned