Senior Supplier Quality Engineer

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.

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Worksite address

maple grove, MN, 55311, US

Who can apply

Review the original listing for work authorization, qualifications and employer requirements.