Overview
Quality Control Inspector Jobs in Chanute, KS at Babcock & Wilcox
Life Science Outsourcing, Inc. (“LSO”) (www.lso-inc.com) is a contract manufacturing organization focused on assembly, packaging, sterilization, and packaging with over 25 years of experience. The Company serves orthopedic, cardiovascular, diagnostic, dental and a variety of other medical specialties. Our unique model is focused on in-house end-to-end portfolio processes and service offerings with deep regulatory knowledge. This provides the agility and flexibility that customers need to accelerate their go-to-market launches while standardizing their supply chain and mitigating risk. Clients rely on LSO to perform all activities required to introduce their products to market, from procurement to final packaging and shipping.
LSO’s is headquartered in Brea, CA (North Orange County). In January 2023, the Company added its east coast facility in Somersworth, New Hampshire (formerly J-Pac Medical).
We are currently seeking a self-motivated QC Inspector with positive, engagement and collaborative energy to join our team and support the continued growth of the New Hampshire Facility. The QC Inspector is responsible for all aspects of the incoming inspection, in-process and final inspection for medical devices, support investigating CAPA and customer complaints, review of DHRs (device history records), internal audits, calibration, and testing for process validation for the Company assuring compliance with all applicable regulations and industry standards. The role requires an individual who can work independently and with a high level of accuracy, as well as a willingness to lead process improvements and mentor junior team members.
We encourage you to submit a resume with salary requirements.
ESSENTIAL FUNCTIONS AND RESPONSIBILITIES – additional duties may be assigned.
Follow written procedures for testing and legibly and accurately document all test data.
Maintaining compliance to appropriate US FDA regulations and ISO 13485 Quality Management System standards by following written procedures.
Working in a team environment with all quality control inspection personnel
Lead and manage the inspection process (incoming, in-process and final) for medical devices, including developing and maintaining inspection procedures, and ensuring compliance with regulatory and company requirements.
Work directly with manufacturing and engineering personnel to test and inspect components and materials.
Review and approve inspection results and related documentation, including NCRs and corrective actions.
Performing investigations for: NCR’s, Preventive and Corrective Actions, Deviations and Complaints
Reviewing Device History Records (DHR) and providing test/inspection support to all new process developments. Reviewing lab results and approve product release.
Provide technical expertise and training to junior QC inspectors and other departments as needed.
Participate in external audits and inspections, including preparing for and responding to audit findings as needed.
Continuously identify areas for process improvement and cost savings, and lead implementation of process improvements. Maintain calibration activities and schedules. Support QC Supervisor as needed.
Maintain accurate and up-to-date records of inspection results and related documentation.
The ability to use manual dexterity to measure, using rulers, calipers, micrometers, and other instruments. Working in a team environment with all quality control inspection personnel.
QUALIFICATIONS -To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required.
High school or GED equivalent, Associate degree in a technical field or equivalent experience
At least 5 years of experience in quality control or a related field, with at least 5 years in medical device manufacturing or a related industry
Strong knowledge of medical device regulations and standards, including FDA regulations and ISO 13485 and GMP.
Knowledgeable in applications of caliper use, calibration and verification of tools, basic math skills and blueprints/drawings comprehension, SPC, IQ/OQ/PQ and quality principles.
Proficiency in using a wide range of measuring tools and equipment.
Detail-oriented with excellent organizational and communication skills.
Attention to Detail in a fast-paced environment
Ability to work independently and as part of a team, and to lead and mentor others.
Proficient in Microsoft Office applications, including Word and Excel.
Any certifications are a plus.
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Title: Quality Control Inspector
Company: Babcock & Wilcox
Location: Chanute, KS
