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.