Mondo
Overview
We are seeking an experienced and motivated
Senior Supplier Quality Engineer
to join our team. In this role, you will lead supplier quality initiatives, ensure compliance with FDA and internal quality standards, and serve as a key technical resource for supplier assessments, audits, and corrective actions. You will work cross-functionally to monitor and improve supplier performance while driving quality improvement projects that ensure patient safety and product excellence. Day-to-Day Responsibilities
Provide
line support
by addressing supplier-related quality issues impacting production. Assess and qualify suppliers to ensure compliance with our standards. Lead
supplier audits
to evaluate compliance with regulatory and quality system requirements (FDA 21 CFR 820, CFR 210/211). Support projects involving specification changes for men’s health devices. Monitor, report, and improve supplier performance and manufacturing capability. Serve as the
technical lead
on sourcing category teams. Develop, implement, and track
supplier corrective actions . Drive and execute
quality improvement projects , mentoring junior engineers as needed. Collaborate with internal stakeholders to align supplier quality objectives with business needs. Ensure compliance with
FDA regulations, internal quality systems, and industry standards . Support cross-functional teams across
global quality operations . Must-Have Qualifications
Bachelor’s degree
in Chemistry, Biochemistry, Chemical Engineering, or related field. 5+ years of relevant experience
in supplier quality engineering, pharmaceutical, or combination drug product industries. Strong knowledge of
FDA 21 CFR 820 and CFR 210/211 . Proven experience in
supplier quality management
and building strong supplier relationships. Excellent communication, problem-solving, and influencing skills. Ability to work independently and lead cross-functional initiatives. Nice-to-Have Qualifications
Experience with
device–drug combination products
or pharmaceutical manufacturing. Knowledge of ISO standards (ISO 13485, ISO 14971) and international regulatory requirements. Prior experience mentoring or coaching junior engineers. Experience implementing continuous improvement methodologies (Lean, Six Sigma). Health, dental, vision, 401k, PTO, parental leave, life insurance, EAP Note: This description excludes non-essential job board boilerplate and focuses on responsibilities and qualifications specific to the role.
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We are seeking an experienced and motivated
Senior Supplier Quality Engineer
to join our team. In this role, you will lead supplier quality initiatives, ensure compliance with FDA and internal quality standards, and serve as a key technical resource for supplier assessments, audits, and corrective actions. You will work cross-functionally to monitor and improve supplier performance while driving quality improvement projects that ensure patient safety and product excellence. Day-to-Day Responsibilities
Provide
line support
by addressing supplier-related quality issues impacting production. Assess and qualify suppliers to ensure compliance with our standards. Lead
supplier audits
to evaluate compliance with regulatory and quality system requirements (FDA 21 CFR 820, CFR 210/211). Support projects involving specification changes for men’s health devices. Monitor, report, and improve supplier performance and manufacturing capability. Serve as the
technical lead
on sourcing category teams. Develop, implement, and track
supplier corrective actions . Drive and execute
quality improvement projects , mentoring junior engineers as needed. Collaborate with internal stakeholders to align supplier quality objectives with business needs. Ensure compliance with
FDA regulations, internal quality systems, and industry standards . Support cross-functional teams across
global quality operations . Must-Have Qualifications
Bachelor’s degree
in Chemistry, Biochemistry, Chemical Engineering, or related field. 5+ years of relevant experience
in supplier quality engineering, pharmaceutical, or combination drug product industries. Strong knowledge of
FDA 21 CFR 820 and CFR 210/211 . Proven experience in
supplier quality management
and building strong supplier relationships. Excellent communication, problem-solving, and influencing skills. Ability to work independently and lead cross-functional initiatives. Nice-to-Have Qualifications
Experience with
device–drug combination products
or pharmaceutical manufacturing. Knowledge of ISO standards (ISO 13485, ISO 14971) and international regulatory requirements. Prior experience mentoring or coaching junior engineers. Experience implementing continuous improvement methodologies (Lean, Six Sigma). Health, dental, vision, 401k, PTO, parental leave, life insurance, EAP Note: This description excludes non-essential job board boilerplate and focuses on responsibilities and qualifications specific to the role.
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