Location: Bloomfield,CT, USA
Primary Duties & Responsibilities
* Own/manage internal Quality Processes including:
* Corrective Action/Preventative Action (CAPA) System
* Internal Inspection - Receiving, In-Process and Final
* Internal Auditing
* Calibration
* Maintain/improve metrics to meet goals
* Drive product issues to Root Cause, ensure implementation of systemic corrective/ preventative actions and monitor effectiveness of those actions.
* Owner of the ISO 9001 certified Quality Management System
* Maintain/Improve an already high-functioning QMS. Ensure its compliance with the Corporate Quality Manual.
* Host regular Quality Management Review meetings
* Host Registrar, Corporate and Customer Audits of the QMS and correct any findings and observations.
Education & Experience
* BS degree, preferably in Engineering or related technical discipline. Post graduate degrees a plus.
* A minimum of 5 years of quality assurance related experience or combination of education and relevant experience
* Relevant experience working in a high-technology and fast-paced manufacturing environment.
* Basic understanding of Inspection equipment including dimensional measurement techniques, calibration of tools, and use of various gauges.
Skills
* Mind-set that is constantly looking to improve work, products, functions, and processes.
* Strong working knowledge of ISO 9001:2015
* Excellent organizational, program management and consensus building skills. Strong at leading by influence.
* Good diplomacy skills in working with other departments (Engineering, Operations, Sales). Ability to negotiate mutually acceptable plans and outcomes.
* Capabilities in Quality related discipline that include Structured Problem Solving (8D), Failure Mode and Effect Analysis (FMEA), Process Validation (IQ, OQ, PQ), Statistical Process Control (SPC), Gauge Repeatability & Reproducibility (GR&R).
* Excellent communication skills (written, verbal, and presentation) to effectively and efficiently interact with Customers, Suppliers, and Colleagues.
* Ability to complete multiple complex independent tasks in a timely manner.
* Ability to do basic statistical analysis using Minitab or JMP is a plus.
* Previous experience with Lean and/or 6-Sigma is a plus.
* Previous experience with Copy Exactly! is a plus.
Working Conditions
* Manufacturing working environment. Some areas under cleanroom protocol.
* Occasional domestic and international travel (