Job Description
Job Summary
The Staff Supplier Quality Engineer ensures that all products and services provided by suppliers meet internal and external quality standards. This role involves leading supplier audits, managing quality metrics, and driving continuous improvement initiatives across the supply base. The engineer acts as a key liaison between suppliers and internal teams, ensuring compliance with regulatory requirements and company standards.
Key Responsibilities:
Supplier Management & Auditing
- Lead and conduct supplier audits (ISO, GMP, FDA, etc.) based on annual schedules.
- Evaluate and approve suppliers for inclusion in the Approved Supplier List (ASL).
- Monitor supplier performance using KPIs.
- Develop and implement supplier certification and re-certification programs.
Quality Systems & Compliance
- Ensure supplier compliance with ISO 13485, 21 CFR 820, and other applicable regulations.
- Maintain and improve Supplier Quality Management metrics and documentation.
- Support CAPA investigations and non-conformance resolution related to supplier issues.
- Facilitate Manufacturing Quality Agreements (MQAs) and ensure proper documentation.
Product Development & Validation
- Collaborate with R&D and manufacturing teams during design and process validation phases.
- Provide input on statistical methods, test methodologies, and validation protocols.
- Support process improvement initiatives and risk assessments using tools like FMEA and DOE.
Training & Mentorship
- Train internal teams and suppliers on quality tools and regulatory requirements.
- Mentor junior engineers and support their development in supplier quality practices.
Post-Market Surveillance
- Investigate supplier-related complaints, MDRs, and recalls.
- Coordinate corrective actions and ensure timely closure of audit findings.
Qualifications:
Education
- Bachelor’s or master’s degree in engineering, Life Sciences, or related technical field.
Experience
- 8+ years in Supplier Quality Engineering, preferably in medical devices or regulated industries.
- Lead auditor experience with ISO 13485 and FDA QSRs.
- Experience with CAPA, process validation, and statistical analysis.
Certifications (Preferred)
- ASQ CQE/CQA
- ISO 13485 Lead Auditor
- Six Sigma Green/Black Belt
Skills
- Strong analytical and problem-solving abilities.
- Excellent communication and negotiation skills.
- Proficiency in quality tools (FMEA, MSA, SPC) and software (MS Office, QMS platforms).
- Ability to travel up to 30% for supplier audits and assessments.
Base Salary - $153,977.00 - $179,986.00