Koya Medical, Inc. · 6 hours ago
Supplier Quality Engineer
Dallas, TX
Full-time
Onsite
Mid Level
$80K/yr - $85K/yr
3+ years expKoya Medical, Inc. is a transformative healthcare company developing breakthrough treatments for venous diseases and lymphedema. The Supplier Quality Engineer will ensure the safety and quality of products throughout the development lifecycle, work with suppliers on corrective actions, and drive continuous improvement initiatives.
BiotechnologyHealth CareInternetPharmaceutical
Responsibilities
Management of Supplier Corrective Actions (SCARs), reworks, CAPA, Design Changes, complaints, scrap and change requests related to suppliers
Guiding suppliers to develop quality control plans by identifying critical control points and implementing preventive measures or test methods, understanding machine or material process limits, monitoring production inspection results, and advising on quality procedures
Owning supplier quality, working cross-functionally with Procurement, R&D, and QC, to implement design controls for pipeline products at our suppliers, and with Manufacturing Operations to maintain risk and process documentation related to the supply chain
Participating in the nonconformance system (NC) including root cause analysis, corrective action implementation and validation, as related to the supply chain
Setting and achieving KPI objectives by developing supplier data collection process, collecting and analyzing data, and implementing continuous improvement initiatives
Providing Supplier Quality expertise to Product Engineering/Design projects
Supporting design review and tolerances definition in line with supplier process capabilities
Supporting supplier process validation and verification, test method validation, and equipment validation
Reviewing drawings and quality documentation
Qualification
Required
Bachelor of Science in engineering or a related field
At least 3 years of experience in a Quality Engineering role in the medical device industry or an equivalent combination of education, training, and experience
Experience in supplier quality engineering, particularly with East Asia suppliers preferred
Experience with a broad range of raw material types is desired; soft good experience is a plus
Resourcefulness, critical thinking and problem-solving skills
A logical and planned approach to all tasks
Takes initiative in everyday work
Exceptional attention to detail
Excellent understanding of GD&T
Excellent understanding of ISO 13485, ISO 14971, and applicable FDA CFRs
A working knowledge of regulatory requirements
Strong data collection and analysis skills
Strong understanding of process controls and validation
Ability to perform root cause analysis and corrective action
Must understand and be able to develop and document inspection methods and practices
Verbal and written communication skills
Able to work within a cross-functional team environment
Able to work with overseas suppliers, including occasional travel
Desire and ability to work in a fast-paced, dynamic environment
Preferred
CQE and/or Lean Six Sigma experience preferred
APQP/PPAP experience preferred
Benefits
Base + bonus compensation package
Competitive benefits program
Company
Koya Medical, Inc.
Koya Medical is a transformative healthcare company developing breakthrough treatments for venous and lymphatic diseases to increase movement, mobility and personalized care that is unavailable with traditional compression therapy.
51-200 employees
Funding
Current Stage
Growth StageTotal Funding
$70.22MKey Investors
OrbiMed3×5 PartnersArboretum Ventures
2023-11-15Series C· $30M
2022-02-03Series B· $26M
2021-01-14Series A· $11M
Leadership Team
Damian Rippole
Chief Operating Officer & Financial Officer
Recent News
2026-01-05
2025-11-21
Company data provided by crunchbase