Proven Recruiting · 4 days ago
Manager, Supplier Quality
Proven Recruiting is seeking a Manager of Supplier Quality to lead supplier quality oversight by managing the qualification, monitoring, and performance of external manufacturers and IVD suppliers. The role ensures compliance with global regulatory standards and drives continuous improvement across the supplier network.
Responsibilities
Lead supplier quality management activities, including qualification, auditing, performance monitoring, and oversight of external manufacturers to ensure compliance with applicable regulations (e.g., ISO 13485, FDA QSR, IVDR)
Manage supplier relationships by conducting risk-based assessments, resolving quality issues, driving corrective actions, and maintaining all supplier documentation, including the Approved Supplier List
Oversee investigations, supplier change reviews, and validation/verification needs; collaborate cross-functionally to support new product introductions, regulatory audits, and continuous improvement efforts
Qualification
Required
Bachelor's degree in a scientific, engineering, or related technical field
6–7+ years of Quality Assurance experience in the medical device or IVD industry
Strong knowledge of supplier quality programs and regulatory frameworks, including ISO 13485, IVDR, and ISO 14971
Demonstrated experience executing audits and managing external manufacturing partners
Excellent communication, organization, and documentation skills
Ability to manage multiple projects
Ability to author SOPs and technical documents
Willingness to travel up to approximately 30% for supplier oversight
Company
Proven Recruiting
Proven Recruiting is a recruiting firm that connects people with careers in technology, finance, accounting, and life sciences.
H1B Sponsorship
Proven Recruiting 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
2020 (1)
Funding
Current Stage
Growth StageTotal Funding
$1.08M2012-05-08Series A· $0.05M
2011-02-08Seed· $1.03M
Recent News
2025-04-12
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