Job DescriptionPrimary 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 (