Job Summary
Perform metrology and inspection for mold approvals, SPC studies, design of experiments, project evaluations, machine and process qualifications, or other metrology requests as required by the engineering group or manufacturing.
Essential Duties and Responsibilities :
Measure and visually inspect new and existing product per established procedures or as instructed. The results will be used to evaluate new projects, materials, equipment, process, etc.
and may result in the acceptance or rejection of that process or product.
- Assist in or establish a method for measuring, evaluating product dimensionally or functionally.
- Dimensionally, visually and functionally evaluate product from the capability studies / PQs, DOEs / OQs, material evaluation, investigations, machine and process qualifications, product from new projects or customers to determine compliance to specifications as well as the variability of the process / product.
- Prepare inspection reports with applicable data and statistical documentation for DOEs / OQs, capability studies / PQs, material evaluations and other related operations.
- Maintain lab preventive maintenance program in accordance with prescribed procedure assuring that tasks are completed to schedule.
- Develop and maintain accurate record systems to assure easy retrieval and proper documentation of information.
- Participate in validation activities as needed.
- Inform Metrology Supervisor of discrepancies or potential problems that could negatively impact quality systems, product efficacy or safety conditions.
- Conforms with and abides by all regulations, policies, work procedures, instruction, and all safety rules.
- Provides a Customer Service attitude when interacting with internal and external customers while accomplishing work, production, and achieving quality standards.
- Maintains a clean, orderly, and safe workstation and environment at all times.
- Other duties as assigned
Basic Qualifications :
- Education : High School or Equivalent
- Experience : Less than 3 years
Preferred Knowledge, Skills, and Abilities :
- Knowledge and experience with FDA and ISO Quality Systems to include SPC and calibrations systems.
- Proficiency with PC and Microsoft Office; Knowledge of QMS Master Control, MeasureLink and other Quality systems is preferred.
- Experience with ISO 9000 standards and GMP’s
- Must be able to prioritize and perform position responsibilities accurately and meet required deadlines.
- Strong attention to detail; Strong problem identification / analysis and solving skills with hands-on approach.
- Excellent verbal and written communication skills; Maintain an organized and clean quality Lab.
- Ability to multi-task and prioritize in a fast-paced environment; Ability to interface with all personnel levels.
- Motivated self-starter with ability to work independently on multiple assignments in a team environment.
Travel Requirements :
Minimal travel may be required.
Physical and Mental Requirements :
While performing the duties of this job, the associate frequently is required to sit, walk, stand, balance, stoop, kneel, or crouch to support production needs.
The associate may lift and / or move up to 25 pounds and occasionally lift and / or move more than 55 pounds.
LI-9394