Major Job Responsibilities/Duties:

• Lead, manage and develop the Continuous Improvement Systems and Procedures.


• Assist Manager with Management System (QMS) while owning document control and ISO 9001:2015 certification.


• Manage implementation and use of Control Plans, 8-D, 5-Why and other tools.


• Works closely with customers and internal departments to resolve issues and implement corrective actions.


• Manage use and application of Root Cause/ Corrective Action (CA) systems for the evaluation of nonconformances including investigation, evaluation, review, reporting, and responding to customers. Will assist in Corrective Action Responses (CARs) necessary to assure timely root cause correction, verification of effectiveness and closure.


• Monitor and track quality process and product control parameters to validate process reliability and capability.


• Develop APQP forms and submit PPAP packets for approval based on customer requirements.


• Daily management of customer portals


• Responsible for QA Hold area and MRB process / meetings


• Calibrate gages onsite / send offsite if necessary and Manage Calibration system


• Lead internal audit scheduling and completion with input and assistance from Manager


• Train on FDA, IMDS, Compliance / Regulatory items and become knowledgeable on all aspects of Compliance.


• Internal / External CAR issuing, tracking, approval, and follow-ups


• Layered Process & General audits

Minor Job Responsibilities/Duties:

• External communications, written and verbal


• Prepare presentations, handouts for meetings


• Drive / Sustain a 6S culture


• Assist QA Tech with product rework as needed


• Layered Process / Training audits


• Other duties as required

Requirements:

• Applicable tools and techniques: working knowledge of Microsoft Office, GagePack, SPC software, PPAP and APQP

• Competency: Able to work independently and with other departments as needed, excellent organizational ability


• Able to multitask and meet short timelines


• Familiarity with ISO 9001 is required


• Physical Demands: Sit up to 8 hours on a regular basis and able to lift 10 pounds on a regular basis, 25 pounds on an occasional basis, 30 pounds on rare occasions