Verathon · 16 hours ago
Manager, Supplier Quality Engineering
Bothell, WA
Full-time
Onsite
Mid, Senior Level
$117K/yr - $159K/yr
6+ years expVerathon is looking for a Manager, Supplier Quality Engineering to join their Quality Assurance Team. The role involves managing and improving the Global Supplier Quality Program and leading a team of Supplier Quality Engineers to ensure compliance with quality standards and regulations.
Manufacturing
Hiring Manager
Lindsey Nakashima
Responsibilities
Set strategy for global Supplier Quality organization
Provide leadership to Supplier Quality Engineers; manage performance through clear goal and expectation setting, accountability, and feedback; maximize the contributions of team members by proactively developing talent
Manage team performance through KPIs/metrics that track team activities and deliverables
Represent Verathon as the primary liaison with contract manufacturers and suppliers for all quality and compliance activities
Develop and implement effective Quality Management System (QMS) processes in compliance with governing regulations and international standards: FDA Quality System Regulations (QSR, 21 CFR Part 820), Canadian Medical Device Regulations (CMDR, SOR 98-292), EU Medical Device Regulation (2017/745), ISO13485, and ISO14971
Mitigate risks that may affect product quality or regulatory compliance
In partnership with Supply Chain Management, improve and manage processes to select new suppliers
Manage component qualification /Production Part Approval Process (PPAP) in alignment with New Product Development and Sustaining Engineering timelines; Ensure adequate process development and validation (IQ/OQ/PQ) occurs for suppliers’ manufacturing processes
Define and execute a risk-based Supplier Quality Audit program; Conduct audits of suppliers to assess the robustness of their Quality Systems, controls, and ability to deliver quality parts
Manage supplier-caused non-conforming material (NCM) through Return to Vendor (RTV) and the Supplier Corrective Action Request (SCAR) processes
Lead investigation and correction of product quality issues
Ensure suppliers properly execute responsibilities under the Supplier Change Notification (SCN) process
Manage tools and mechanisms for ensuring supplier performance (Supplier Quality Agreements and Supplier Scorecards)
Lead continuous improvement in QMS and suppliers’ manufacturing processes
Leverage lean and six sigma methodologies
Qualification
Required
Bachelor's degree and 8+ years of Quality experience (including 4 years' experience in supplier quality roles) or master's degree and 6+ years of Quality experience
3+ years prior experience as a people leader
Bachelor's degree required
Skill in analytical problem solving, root cause analysis, and driving corrective actions required
Professional interpersonal and communication skills
Ability to build relationships with key personnel in supplier organizations
Ability to ask the hard questions while still maintaining collaborative relationships, particularly in the investigation and resolution of product quality issues
Experience and aptitude as a Quality Management System Lead Auditor required
Ability to work under time constraints to meet strategic objectives
Ability to prioritize effectively and deliver results
Ability to travel up to 25% with international travel required
Preferred
Mechanical, Electrical, or Biomedical Engineering or Business Management (Supply Chain) Degree is preferred
Experience in Aerospace (AS9145 APQP/PPAP) or medical device (ISO 13485) industries is preferred
ASQ Certification, such as Certified Manager of Quality/Organizational Excellence (CMQ/OE), Certified Quality Engineer (CQE), Certified Reliability Engineer (CRE), Certified Quality Auditor (CQA) is preferred
Experience in product safety (IEC 60601 Standards) is preferred
Experience in Lean Six Sigma is preferred
Benefits
Medical
Dental
Vision
Basic life insurance
Paid holidays
Paid time off
401(k) matching plan
Company
Verathon
Verathon has designed, manufactured and marketed pioneering medical devices.
501-1000 employees
H1B Sponsorship
Verathon has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2021 (1)
Funding
Current Stage
Late StageTotal Funding
unknown2009-11-09Acquired
Leadership Team
Tracy Olson
Vice President, Finance & Chief Financial Officer
Recent News
Research and Markets
2025-04-26
Company data provided by crunchbase