SMC Ltd · 17 hours ago
Supplier Quality Engineer
Santa Rosa, CA
Full-time
Onsite
Entry, Mid Level
$86K/yr - $103K/yr
2+ years expSMC Ltd is focused on ensuring supplier quality through effective quality systems management. The Supplier Quality Engineer will lead supplier audits, manage supplier performance, and collaborate with cross-functional teams to drive continuous improvements and ensure compliance with quality standards.
ManufacturingMedical Device
Responsibilities
Plan, conduct, and document supplier audits to ensure compliance with quality standards and regulatory requirements
Manage supplier classification changes/updates and maintain accurate supplier records and information
Open, track, and follow up on Supplier Corrective and Preventive Actions (CAPAs) to drive timely resolution
Collaborate with Quality Engineers (QEs) on customer complaints related to supplier performance
Provide Supplier Scorecard inputs to support supplier performance monitoring and evaluation
Review, assess, and process supplier change requests in alignment with quality and regulatory requirements and in collaboration with applicable stakeholders
Support supplier selection, classification, and initial evaluations for new and existing suppliers
Manage Supplier PPAPs (Production Part Approval Process), including record creation in IQMS and communication with suppliers and customers
Collaboration in the development/improvement of receiving inspection instructions/techniques of purchased parts
Lead supplier Qualifications including (not limited to) activities such as, supplier Measurement System Analysis (MSA), tolerance and GD&T reviews, FMEA, control plans, FAI and DOE input for purchased components
Provide inputs and collaborate on Advanced Quality Plans (APQP) to ensure robust product launches and process controls
Contribute to the Validation Master Plan for purchased components and services, integrating supplier requirements into the overall validation strategy
Provide Supplier Quality technical support to Program Management Department
Collaborate in Engineering Change orders that impact purchase part or services
Identifies and addresses opportunities for improvement to supplier related processes
Develops, maintains and updates Procedures, Work Instructions, and Forms
Point of contact for suppliers, internal and external customers for supplier related issues
Supports the ISO 13485 Business Management System through Internal Auditing
Assist with third party and FDA quality audits as needed
Perform other duties as assigned
Qualification
Required
Bachelor's degree in Engineering or a related technical discipline
2–4 years of experience in a Supplier Quality role within the medical device manufacturing industry, with strong knowledge of ISO 13485:2016 and 21 CFR Part 820 requirements
Hands-on experience with Gage R&R, CpK/PpK studies, and Design of Experiments (DoE)
Proficiency in validation/qualification activities (IQ, OQ, PQ)
Solid knowledge of risk management standards (ISO 14971) and application of risk assessment techniques such as FMEA
Familiarity with quality processes and tools including CAPA, PPAP, Root Cause Analysis, and structured problem-solving methodologies (e.g., 8D, 5 Whys)
Experience planning and conducting supplier audits to ensure compliance with quality standards and regulatory requirements
Strong understanding of ISO 13485 quality systems and regulatory expectations under 21 CFR 820
Proficient in Minitab and the Microsoft Office Suite (Excel, Word, PowerPoint, Outlook)
Excellent interpersonal, verbal, and written communication skills
Proven ability to prioritize tasks, manage time effectively, and meet deadlines
Detail-oriented, with a strong focus on accuracy, consistency, and quality in deliverables
Ability to read, write, and communicate effectively in English
Preferred
Experience with metrology equipment, measurement methods, and inspection techniques
Proficiency in CMM and MicroVu programming for precision measurement and validation
Project Management training or certification (e.g., PMP or equivalent)
Six Sigma Green Belt certification or demonstrated application of Lean Six Sigma methodologies
Certified Lead Auditor or completion of recognized lead auditor training
Company
SMC Ltd
SMC Ltd. offers global solutions, contract manufacturing and molding services for the medical device, diagnostics, and pharmaceutical industries.
501-1000 employees
H1B Sponsorship
SMC Ltd 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
2025 (1)
2024 (1)
2022 (1)
Funding
Current Stage
Late StageLeadership Team
Carlos Castro
Talent Acquisition Partner
Jeff Burke
Human Resource Partner
Company data provided by crunchbase