Supplier Quality Engineer

Intellectt Inc; Minnesota; On-site; USD 110,000 - 160,000; Full time

Job summary

Intellectt Inc. is seeking a Senior Supplier Quality Engineer to lead supplier qualification efforts for critical components, working with R&D, Design Assurance, Operations, Regulatory, and supplier development teams.

The role emphasizes proactive leadership in a fast-paced, on-site environment to meet development and launch timelines. You will drive gage studies, process validations, and test method development, while coordinating CAPAs and SCARs with external suppliers and internal

Qualifications

• Experience with FDA/ISO quality systems and regulatory requirements.
• Proven ability to lead qualification and validation activities.
• Strong data analysis and problem solving skills.
• Ability to communicate quality risks to leadership.

Responsibilities

• Lead gage studies, process capability studies, and supplier validations.
• Develop and validate inspection methods and fixtures; use SolidWorks for fixtures.
• Support Receiving Inspection with test methods and investigations.
• Manage supplier corrective actions from start to finish.
• Report supplier qualification status at cross-functional meetings.
• Analyze quality metrics for Supplier Quality.

Skills

FDA 21 CFR 820/ISO 13485

Design Controls

Statistical methods

Gage R&R/SPC

Root cause analysis

GD&T reading

CAPA management

Tools

SolidWorks

Job description

The Senior Supplier Quality Engineer will play a key role on critical projects. This position is cross-functional in nature and requires strong collaboration and partnership with R&D, Design Assurance, Operations, Regulatory Affairs, Supplier Development Engineering and Receiving Inspection. The primary focus of the position is leading successful parts qualification efforts with external suppliers to support product development and commercial launch timelines. The Sr. Supplier Quality Engineer will work on-site in a very fast-paced and dynamic environment where being proactive and taking initiative are paramount to success.

Job Responsibilities:

• Lead/perform gage studies, process capability studies, and supplier process validations related to critical component features based on risks identified in FMEAs.
• Develop and validate test methods, which can encompass creating inspection routines on optical measurement equipment and design and creation of inspection fixtures using SolidWorks.
• Provide engineering support to Receiving Inspection on component test methods and investigations.
• Manage supplier corrective action requests (SCAR) from initiation to closure.
• Report on supplier part qualification status at recurring cross-functional project meetings.
• Collect and analyze Quality metrics relating to Supplier Quality.
• Communicate supplier quality risks to upper management during Management Review and project meetings and identify solutions to mitigate risks.

Skills:

• Knowledge and understanding of FDA’s 21 CFR Part 820, ISO13485, ISO9001, and other International Regulatory Standards.
• Experience and/or proficient knowledge of Design Controls and test method development/validations.
• Demonstrated experience driving component testing, test method validations, and testing/validating equipment.
• Experience with statistical techniques and tools such as Gage R&R, Statistical Process Control, or Process Capability Studies.
• Ability to conduct effective root cause analysis; driving non-conformance investigations; and assessment of corrective action strategies and effectiveness as applied through CAPAs.
• Knowledge of GD&T and ability to read and interpret drawings.
• Good understanding of process validations (IQ, OQ, PQ)
• Good understanding of manufacturing processes (i.e., injection molding, extrusion, machining, etc.).
• Good interpersonal skills, with the ability to negotiate and influence change.
• Possess the ability to multi-task, while maintaining high attention to detail.
• Ability to achieve results in cross-functional team environment and build strong relationships with internal and external customers (suppliers).