Salary: $15 per hour plus benefits
Date Posted: January 15, 2018
Job Type: Temporary to Hire
Job ID: 293194
Quality Inspector – Medical Device
Growing medical device company is expanding their team to include a Quality Inspector. You will be playing a key role as the company moves from the research stages into commercialization of their product. This is a great chance to get in on the ground floor.
Job Type: Full-time, Contract to perm
Compensation: $15 per hour plus health benefits
· Performs visual, dimensional and functional inspection and testing of completed product according to documented policies and procedures
· Performs the necessary physical testing measurements and visual inspection to incoming material
· Records inspection and test data as prescribed by written instructions and procedures
· Operates all associated test and measurement equipment as instructed and as documented in procedures
· Develops inspection methods and develops and recommends changes to inspection procedures
· Writes procedures for inspection methods
· Recommends changes to policies, procedures and inspection requirements
· Documents non-conformances
· Performs testing and inspection in accordance with special test requests
· Assists in gathering, analyzing and trending of data
· Reads and understands technical specifications and/or work order information for specified materials and dimensions
· Completes quality examinations by applying knowledge of proper company documentation or customer supplied procedures and applicable sampling criteria
· Aids in problem solving for product and quality process issues
· Participates in quality assurance internal auditing
· Assists, as necessary, with the inspection, measuring and test equipment calibration program
· Contributes to first article inspections by providing quality control support to the supplier or R&D, as required
· Performs other related duties as assigned
· Maintains applicable device history records in accordance with the record management requirements
· Two-year technical degree or equivalent is required.
· Minimum of three years prior medical device component inspection experience is required. Working knowledge of GMP compliance for Class II Medical Devices. FDA QSR (cGMP) knowledge required, ISO 13485 also preferred. Good communication and computer skills, including Microsoft Word and Excel. Must be willing to work overtime as required, including weekends.
· Experience using measurement equipment such as calipers, optical comparator, etc.
· Ability to accurately document and maintain records.
· Proficiency with current Microsoft Office including Word, Excel and Visio software.
· Good written and verbal communication skills.
· Ability to lift up to 25 lbs.
· Ability to work well within a team and complete assigned tasks quickly, effectively and with minimal supervision
· Self-starter, detail oriented and results driven
· Ability to work within established timelines
· Familiar with ANSI/ASQ Sampling Plans
· Must be willing to submit to thorough background screen and drug test