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Diasorin · 20 hours ago

Supplier Quality Manager

Cypress, CA

Full-time

Onsite

Senior Level

$120K/yr - $140K/yr

7+ years exp

Diasorin is a global leader in diagnostic solutions dedicated to improving healthcare worldwide. The Supplier Quality Manager will develop and manage the supplier quality program within an in vitro diagnostics manufacturing environment, ensuring compliance with regulatory requirements and company standards while collaborating with various departments to drive supplier qualification and continuous improvement.

BiotechnologyHealth Diagnostics

H1B Sponsor Likely

Responsibilities

Develop, implement, and maintain the supplier quality management program

Manage and conduct supplier audits in accordance with FDA, ISO 13485, MDSAP, and IVDR requirements

Qualify and approve new suppliers, materials, and services for use in IVD manufacturing

Manage supplier corrective actions (SCARs) and ensure timely resolution of quality issues

Assign and Manage Supplier Quality Scorecard assessments

Collaborate with Procurement and R&D during supplier selection and qualification

Review and approve supplier change notifications

Monitor supplier performance metrics and drive continuous improvement initiatives

Ensure supplier compliance with product, regulatory, and contractual requirements

Act as SME during regulatory inspections for supplier management topics

Manages Regular Supplier Review Board Meetings (global)

Lead risk assessments for suppliers and support overall supply chain risk management

Other duties as assigned

Qualification

Supplier Quality ManagementQuality AssuranceRegulatory ComplianceRisk ManagementAuditingElectronic Quality Management SystemsASQ CertificationsProblem-solvingCommunication SkillsNegotiation SkillsTime Management

Required

Bachelor's degree in Engineering, Life Sciences, or related field required

7+ years of experience in Quality Assurance within IVD or medical device manufacturing

3+ years of experience in supplier quality management or related role

Proven experience leading audits (internal and external)

Experience with FDA 21 CFR 820, ISO 13485, IVDR, and ISO 14971 risk management

Strong knowledge of supplier quality principles, auditing, and risk management

Thorough knowledge of FDA regulations and cGMP guidelines. ISO 13485, IVDR

Excellent problem-solving and root cause analysis skills

Highly organized with proven time-management skills

Strong communication and negotiation skills with suppliers and internal teams

Proficiency with electronic Quality Management Systems (eQMS)

Preferred

Master's degree preferred

ASQ certifications (CQA, CQE, or equivalent) preferred

Benefits

A comprehensive plan of health benefits

Retirement and financial wellbeing

Time off programs

Wellbeing support and perks

Participate in an annual incentive program

Company

Diasorin

Glassdoor3.1

DiaSorin is an Italian multinational Group and a global leader in the market for in vitro diagnostics

Founded in 1968

Saluggia, Piemonte, ITA

1001-5000 employees

https://www.diasorin.com/

H1B Sponsorship

Diasorin 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)

2022 (1)