MAIN DUTIES & RESPONSIBILITIES:
* Interprets drawings featuring Geometric Dimensioning & Tolerancing (GD&T) per ASME Y14.5 to identify product inspection requirements.
* Writes and edits programs utilized in manufacturing PC-DMIS, MCOSMOS & CALYPSO, etc
* Serves as technical expert for metrology inspection.
* Facilitates, encourage and coordinate continuous improvement with respect to inspection activities.
* Set-up data collection parameters for inspection measurements where required.
* Installation of inspection assets as to follow local validation lifecycle.
* Develops inspection strategies to meet business needs.
* Development of new inspection techniques as required.
* Development of standard platforms where applicable (vision systems, contact/non contact inspection systems.
* Develop method of “gauge” evaluation to consider, calibration frequencies, gauge life, fit for purpose, etc.
* Generates the inspection report per the customer requirements.
* Performs 1st Article inspection of newly developed product.
* Site lead on development of inspection fixturing to ensure minimum measurement error during inspection.
* Inspect complex machined fixtures, and parts using advanced measuring and layout instruments and equipment.
* Participates in design reviews on cross-functional teams to ensure that conformance to specifications, inspect ability, reliability, and quality system objectives are met.
* Assist engineers with qualification and validation of new or changed tooling or parts.
* Prepare detailed inspection documentation such as written descriptions of inspection results including deviations from engineering specifications.
* Work from written or verbal instructions, detailed engineering drawings, and 3D models.
* Writing of work instructions for inspection techniques relating to standard platforms for associates.
* Development of validation approach in conjunction with QA for all inspection platforms.
* Training of QA/Manufacturing personnel to execute measurement method/equipment.
PRINCIPLE ACCOUNTABILITIES:
Process Excellence – Continuous Process Improvement
Inspection of products.
GMP
KEY COMPETENCIES REQUIRED:
* High Attention to Detail
* Pro-active approach to Work
* High Standards
* Flexible
* Excellent Communication Skills
* Analytical Skills
* Team Player
* High level of Numeracy
* Computer Literate
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QUALIFICATIONS & EXPERIENCE
ESSENTIAL:
* Proficient in writing and editing CMM programs (PC-DMIS/COSMO/CALYPSO)
* Proficient in set-up and operation of inspection equipment
* Proficient in metrology methods/technology
* Proficient in reading/interpreting engineering drawings and the application of Geometric Dimensioning & Tolerancing (GD&T) per ASME Y14.5
* Proficient in mathematical applications- Algebra, Geometry, & Trigonometry
* Proficient in Microsoft Word & Excel.
* Excellent interpersonal & communication skills
* Knowledge of mechanical inspection methods and tools used to determine product acceptance
* Ability to investigate and learn new technologies within metrology
DESIRABLE:
* Certificate / Diploma / Degree in Quality / Manufacturing / Engineering
* Minimum 3 years in CMM programming PC-DMIS/COSMOS/CALYPSO programming experience desirable.
* Experience of laser scanning techniques and other inspection technologies.
* Knowledge of 21 CFR 820, 21 CFR 11 and European regulations associated with the medical device industry
* High understanding of GMP
* Working knowledge of Quality Systems (FDA/ISO) within a regulated environment.
* Familiarity with statistical analysis software.