Supplier Quality Engineer (f/m)

Ensera Group; Town of Poland (NY); Vor Ort; USD 70.000 - 90.000; Vollzeit

Zusammenfassung

A healthcare packaging company based in New York is seeking a Supplier Quality Engineer responsible for ensuring compliance and continuous improvement of suppliers for medical devices and pharmaceutical packaging materials. The ideal candidate will evaluate suppliers through audits and risk assessments, maintain regulatory documentation, and collaborate with multiple departments to drive enhancements. Qualified candidates should have a Bachelor's degree and 3–7 years of experience in supplier quality or quality engineering, along with strong knowledge of ISO standards and FDA regulations. This is an exciting opportunity to make a significant impact in a leading healthcare environment.

Qualifikationen

• 3–7+ years of experience in supplier quality or quality engineering.
• Strong knowledge of FDA regulations and EU MDR.
• Experience with CAPA and root cause analysis.

Aufgaben

• Evaluate and qualify new suppliers for compliance.
• Conduct supplier audits to ensure regulatory compliance.
• Maintain the Approved Vendor List and supplier documentation.

Kenntnisse

ISO 13485 knowledge

Quality engineering

Supplier audits

Project management

Fluent in English

Ausbildung

Bachelor’s degree in Engineering, Quality, Life Sciences

Tools

FMEA

Risk management tools

Jobbeschreibung

This role is responsible for ensuring the quality, compliance, and continuous improvement of suppliers for medical device and pharmaceutical packaging materials through audits, risk assessments, performance monitoring, issue resolution, and close cross‑functional collaboration.

Your responsibilities

• Evaluate, qualify, and support purchase department activities related to approving new suppliers for medical devices and pharmaceutical packaging materials (e.g., plastics, films, foils, labels, cartons, sterile barriers).
• Conduct supplier audits (on-site and remote) to ensure compliance with ISO 13485, ISO 9001, GMP, and all applicable regulatory requirements.
• In cooperation with the Purchasing Department, maintain the Approved Vendor List (AVL) and ensure all supplier documentation (quality agreements, certificates, validation records) is up to date.
• Support supplier onboarding and risk assessment (FMEA, risk-based qualification).
• Ensure supplier processes and materials comply with applicable regulations and standards, e.g. FDA 21 CFR Part 820/211, EU MDR, ISO 11607, etc.
• Coordinate with suppliers to obtain and confirm declarations on material composition and the absence of prohibited substances in accordance with EU‑MDR 2017/745 requirements.
• Perform periodic supplier performance evaluations and prepare results for management review.
• Support incoming inspection strategies, sampling plans, and material specifications.
• Prepare and oversee supplier nonconformance reports for materials outside specifications, and lead root cause analysis along with corrective and preventive actions (CAPA) for supplier-related issues.
• Support efforts to reduce supplier nonconformances.
• Collaborate with Engineering and Supply Chain Department to drive continuous improvement initiatives with suppliers, focusing on process enhancements and risk mitigation.
• Ensure proper process controls, validations, and adherence to GMP practices.
• Facilitate supplier review meetings and performance feedback. Prepare supplier quality reports, dashboards, and management review inputs.
• Support the Purchasing Department in managing supplier selection, contract negotiations, and quality agreements.
• Assist in resolving incoming inspection yield issues by driving process improvements with suppliers.
• Complete any other job as assigned by manager and complete the assignment given within the agreed time frame.

Our requirements

• Bachelor’s degree in Engineering, Quality, Life Sciences, or related field.
• 3–7+ years of work experience in supplier quality, quality engineering, or manufacturing quality in medical devices, pharmaceuticals, or regulated packaging.
• Strong knowledge of ISO 13485, GMP, FDA regulations, and/or EU MDR.
• Experience with supplier audits, CAPA, root cause analysis, and risk management tools.
• Familiarity with packaging materials (plastics, sterile barriers, labels, cartons) and validation requirements is highly desirable.
• Ability to interpret technical drawings, specifications, and validation protocols.
• Willing to learn, independent, initiative and proactive.
• Self‑motivated and able to work in a team and with minimum supervision.
• Strong project management and leadership skills, including the demonstrated ability to lead multi‑departmental project teams and resolve quality-related issues in a timely and effective manner.
• Experience implementing various product and process improvement methodologies (e.g., Six Sigma and Lean Manufacturing).
• Fluent in English, both written and spoken.