Job Description
Job Description
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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