Supplier Quality Engineer

SunMed Group Holdings, LLC dba AirLife•Grand Rapids, MI

12d

About The Position

The Supplier Quality Engineer is responsible for ensuring the quality and compliance of all externally sourced components, materials, and finished goods for AirLife. This role owns the supplier assessment and approval process, ensuring proper documentation, certifications, and evaluations are maintained in alignment with AirLife procedures and ISO-13485 requirements. The Supplier Quality Engineer drives continuous improvement in supplier performance through technical support, routine monitoring, corrective actions, and supplier development initiatives. This position leads supplier audits, manages Supplier Corrective Action Requests (SCARs), and supports investigations related to supplier nonconformances. It also plays a key role in reviewing and executing supplier-initiated change requests, ensuring appropriate validations and design verification activities are completed. The role develops acceptance criteria for purchased products to ensure design and regulatory requirements are met and collaborates cross-functionally with Engineering, Sourcing, Sales, Marketing, and New Product Development teams.

Requirements

ISO-13485
3+ years of SQE experience.
A minimum B.S. in mechanical, biomedical, industrial, or manufacturing engineering is preferred.

Nice To Haves

ASQ Certification is preferred.
Lead Auditor Certification is preferred.

Responsibilities

Owns the assessment and approval of suppliers, along with assurance of proper documentation, certifications, and assessment in alignment with AirLife procedures.
Drives improvement in the quality of components and finished goods sourced from outside suppliers.
Provides technical support in the selection of suppliers and manufacturing processes.
Monitors supplier performance via annual evaluations and monthly scorecards to drive supplier development.
Initiates and manages Supplier Corrective Actions (SCARs).
Supports nonconformance investigations for supplier related issues identified through inspection or complaints.
Supports the review and execution of supplier-initiated change requests, including assurance of validations and design verification activities.
Serves as lead auditor for supplier audits in compliance to ISO-13485.
Conducts assessments and provides input to support the integration activities of AirLife.
Supports the review and execution of supplier-initiated change requests, including assurance of validations and design verification activities.
Develops acceptance criteria for purchased components and finished goods that demonstrate supplier capability while in alignment with design requirements.
Collaborates with Sustainment Engineering, New Product Development, Sales, and Marketing on new opportunities and product improvements.
Leads activities for the qualification of OEM devices and the supplier selection for NPD.
Drives the strategic roadmap of supplier development in partnership with sourcing and engineering.