Senior Supplier Quality Engineer

POSITION SUMMARY

The Supplier Quality Engineer is responsible for managing supplier quality, and leading the CAPA program for supplier non-conformances. Coordinates and drives improvements in quality, cost, and delivery. Extensive knowledge of quality system requirements ISO 13485 & CFR 820. Relies on experience and judgment to plan and accomplish goals. Works independently with minimal supervision.

PRINCIPAL RESPONSIBILITES

• Supports supplier qualification/approval process by assessing supplier QMS as well as manufacturing and technology capabilities through onsite and virtual audit activities.
• Supports design, development, and manufacturing operations toward resolution of supplier quality problems as well as the implementation of corrections and corrective actions.
• Supports design, development, and manufacturing operations toward implementing changes within the supply base by leading the change control process for dedicated Tecomet facilities.
• Partners with suppliers to establish and maintain controlled manufacturing processes.
• Facilitates root cause analysis and corrective actions for supplier quality issues (SCARs).
• Report supplier quality trends, performance, and other information to leadership.
• Assists in contract/order reviews.
• Leads efforts to reduce supply base in coordination with other Tecomet facilities.
• Participates in design review for the purpose of working with suppliers to establish and maintain robust/rigorous measurement methodologies.
• Supports supplier validation activities by assisting with FMEA's and Control Plans., Special Process Validations
• Performs internal audits to ensure quality compliance.
• Utilize Tecomet Supplier Portal / Intranet for real-time metrics tracking with supplier.
• Maintain supplier quality document repository
• Perform supplier performance reviews and maintain supplier audit schedule as required.
• Assists in other Quality Engineering duties as needed.
• Travel up to 50% may be required.

REQUIRED KNOWLEDGE, SKILLS, AND ABILITIES

• Regulatory cGMP, QSR and ISO knowledge base preferred.
• Computer literate/proficient with Microsoft Office applications.
• Negotiation and problem-solving skills.
• Good oral and written communication skills; ability to properly speak and write in the English language.
• Math aptitude: strong statistical skills required (DOE, SPC, Reliability, Gage R&R).
• Experience in the area of manufacturing operations preferred.
• Ability to multi-task, prioritize and work independently.

EDUCATION AND EXPERIENCE

• B.S. degree in Engineering preferred, or equivalent experience.
• Minimum of three (3) years with medical device experience in manufacturing operations, process qualification, and/or quality engineering preferred.
• ASQ Certification a plus.

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