Senior Inspector
MedTechPharmaRegulatory AffairsQuality Assurancecro
Job description
Assesses devices in-process and upon completion to ensure regulatory and company guidelines have been met and devices meet operational standards as designed. Key Responsibilities: • Perform visual, dimensional, and functional inspection across all components and/or finished medical device products using a wide variety of tools and equipment to ensure conformance with design specifications while working independently at the highest levels of productivity. Highlight and escalate work issues to Lead • Perform functional testing of finished medical device products using both automated and manual valve testing equipment • Perform verification of quality records which include Device History Records review and/or product release for interplant shipment or distribution. May include Geometric Dimensioning and Tolerancing methodologies. • May control inventory to ensure appropriate storage conditions and movement • Other incidental duties: General work area housekeeping Education and Experience: Secondary Education in including technical training years Preferred or 4 years experience previous related in manufacturing and QC experience Required Additional Skills: • Strong communication and interpersonal relationship skills, including ability to convey training in methodology and procedures • Ability to read, comprehend, speak, and write English • Good computer skills, required, including working knowledge of manufacturing software • Ability to use applicable tools and equipment, hand eye coordination, and high manual dexterity • Full understanding of applicable inspection procedures, including the ability to contribute to the development of procedures • Proficient in all inspection techniques for production inspection • Ability to clearly describe and convey nonconformance issues, and enter them into QMS (Quality • Ability to program and contribute to the validation of automated test equipment • Strict attention to detail • Must be able to work in a team environment, and may work on inter-departmental teams • Ability to effectively provide and accept feedback from colleagues • Adhere to all company rules and requirements (e.g., pandemic protocols, Environmental Health & Safety rules) and take adequate control measures in preventing injuries to themselves and others as well as to the protection of environment and prevention of pollution under their span of influence/control
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