Senior Supplier Quality Engineer

Nextern; Maple Grove (MN); On-site; USD 85,000 - 125,000; Full time

Benefits offered by this job

Health plan (Medical, Dental & Vision)

Retirement plan with company match

Paid time off & Personal days

Birthday holiday

Life insurance & AD&D

Disability insurance

Wellness resources

Job summary

Nextern in Minnesota is seeking a Supplier Quality Engineer to partner with development, manufacturing, supply chain and quality teams to onboard and qualify new suppliers and monitor ongoing performance. You will act as the primary liaison to Nextern suppliers for quality communications, change notifications, audits and CAPA, while ensuring compliance with 21 CFR 820 and ISO 13485.

This role requires leadership, data analysis, and the ability to coordinate supplier visits and audits to drive

Qualifications

• BS in life science or equivalent education/experience.
• 10+ years in medical device quality 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).
• Strong communication and leadership across disciplines.

Responsibilities

• Partner with development, manufacturing, supply chain and quality teams to qualify suppliers.
• Assess supplier material and characteristics for categorization and monitoring.
• Maintain supplier files for traceability and supplier data linkage.
• Coordinate supplier change notifications and supplier corrective actions (SCARs).
• Lead supplier audits and support internal audits as SME for QMS processes.

Skills

Quality leadership

Regulatory knowledge

Data analysis

Quality tools (CAPA, RCA)

Communication

Education

BS in life sciences

Tools

Windchill

Agile

Propel

Minitab

MS Office

Job description

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
• Other duties as assigned

SUPERVISORY RESPONSIBILITIES:

• Carries out supervisory responsibilities in accordance with the organization's policies and applicable laws
• Interviews, hires, and trains employee(s). Manages employee(s) work direction, resource load, review/appraisal, and career development. Addresses and support resolution of employee complaints/issues.

QUALIFICATIONS:

• 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)

• 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.