Sr. Supplier Quality Engineer

Nextern; Maple Grove (MN); On-site; USD 110,000 - 125,000; Full time

Benefits offered by this job

Health Plan

Retirement Plan with Company Match

Paid Time Off

Birthday Holiday

Life Insurance

Family Leave

Short-Term / Long-Term Disability

Snacks & Wellness Resources

Job summary

Nextern is seeking a seasoned Supplier Quality Engineer in Minnesota to lead supplier onboarding, qualification, and monitoring across the material and component supply chain. You will partner with development, manufacturing, and quality teams to ensure supplier documentation, change management, and NC/CAPA processes are robust and compliant.

Ideal candidates bring 10+ years in medical device quality or 5+ years in supplier quality engineering, with ISO 13485 and 21 CFR 820 experience, and

Qualifications

• Bachelor's degree in life science or equivalent experience.
• 10+ years in medical device quality function, or 5+ years in supplier quality/engineering.
• Experience with 21 CFR 820 and ISO 13485 quality systems.
• ISO 13485 Lead Auditor certification (BSI or equivalent).
• Understanding of ISO 14971 risk management for supplier qualification.
• Strong technical leadership in quality and attention to detail.
• Excellent written and verbal communication across teams.
• Experience with quality tools: nonconformance, CAPAs, root cause analysis.
• Familiarity with Minitab; PLM software Windchill/Agile/Propel; MS Office.

Responsibilities

• Partner with development and supply chain to onboard and monitor suppliers.
• Assess material and supplier characteristics for categorization.
• Maintain supplier files to ensure traceability and control.
• Ensure supplier docs meet business and program requirements.
• Handle supplier change notifications and coordinate SMEs.
• Lead Supplier Corrective Action Requests (SCARs).
• Coordinate material testing for supplier qualification.
• Define monitoring plans for receiving inspection and supplier data.
• Analyze and present supplier performance metrics for reviews.
• Own supplier selection, qualification, and monitoring QMS processes.
• Lead audits and support external/internal audits as SME.
• Identify efficiency improvements in Quality System requirements.

Skills

Quality systems knowledge

Supplier quality leadership

Root cause analysis

Communication skills

CAPA management

Audit coordination

Statistical software (Minitab)

PLM software experience

Education

Bachelor's Degree in life science or equivalent

Tools

Windchill

Agile

Propel

Minitab

MS Office

Job description

At Nextern, we inspire with passion, impact with significance, and act with integrity.. Nextern partners with OEMs, clinicians, and innovators to design, develop, and manufacture world-class medical devices across the full product lifecycle. From single-use disposables to fully integrated systems to precision components, our teams work as an extension of yours to solve patient needs and improve lives worldwide.

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.

DUTIES AND 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

• 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..)
• 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)

Salary Range - $110,000 to 125,000 based on skills and experience

• Health Care Plan (Medical, Dental & Vision)
• Retirement Plan with Company Match
• Paid Time Off, Personal Days, AND Birthday Holiday!
• Lifetime Membership Subsidy and Wellness Resources
• Life Insurance (Basic, Voluntary & AD&D)
• Family Leave (Maternity, Paternity)
• Short-Term & Long-Term Disability
• Taco Thursdays!!!

Nexternis an equal opportunity employer. We encourage applications from candidates of all backgrounds and experiences, and we are committed to fostering an inclusive and diverse workplace. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.