Job Details
Company Description
(www.lso-inc.com) is in North Orange County in the city of Brea, California. Life Science Outsourcing, Inc (LSO) is a contract manufacturer of medical devices with in-built capabilities to offer clients full-service solutions through our six divisions. Clients rely on LSO to perform all activities required to introduce their products to market, from sourcing to drop shipping.
- In January of 2023 LSO acquired J-Pac Medical (www.j-pacmedical.com), a Medical Device Contract Manufacturer based out of New Hampshire to expand LSOs geographic reach in the medical device arena. Due to the recent acquisition and with over 25 years of growth, we are currently seeking a self-motivated 2nd shift Quality Inspector with a good positive energy to join our team at the New Hampshire Facility in Somersworth.
The
2nd shift Quality Inspector is responsible for quality assurance and quality manufacturing functions such as generating certificate of compliance, inspection and testing, disposition of product, incoming inspection, in-process and final inspection, review of DHRs (device history records).
We encourage you to submit a resume with salary requirements.Job Description- Following written procedures for testing and legibly and accurately documenting all test data.
- Communicate test data results and findings that are outside specified limits
- Maintaining compliance to appropriate US FDA regulations and ISO 13485 Quality Management System standards by following written procedures.
- Submitting and maintaining test result documents
- Working directly with manufacturing and engineering personnel to test and inspect components and materials
- Promoting the smooth flow of products through quality control to disposition
- Providing test and inspection support to all new process developments
- Reviewing Device History Records (DHR)
- Reviewing all lab results and approve product release.
- Working in a team environment with all quality control inspection personnel
- The ability to use manual dexterity to measure, using rulers, calipers, micrometers, and other instruments.
- Special projects as necessary
Education and Experience - High school degree or GED equivalent required.
Not Required but preferred:
2 years of experience in a medical device manufacturing or pharmaceutical environment, or 5 years' experience in a general manufacturing environment.
Knowledgeable in applications of caliper use, calibration and verification of tools, basic math skills and blueprints/drawings comprehension, IQ/OQ/PQ and quality principals. Basic knowledge of Good Manufacturing Practice. Basic knowledge in Quality Management Systems applicable to the medical device industry. Proficient in Microsoft Office Suite skills including electronic mail, record keeping, routine database activity, word processing, spreadsheets, graphics, etc.
QualificationsThe
2nd shift Quality Inspector will have the following personal skills and attributes (in addition to the technical requirements for the job already mentioned):
- Attention to detail in a fast-paced environment
- Ability to work independently and take initiative
- Good interpersonal, communication (both verbal and written)
- Strong verbal and written communication skills
- Excellent organizational skills with the ability to handle multiple projects
- Passion for customer service and business growth
- Displays courtesy, tact and patience during interactions with all employees and customers
- Confident and creative
- Acts in an ethical manner at all times and demands the same in others
- Experience in process troubleshooting and timely resolution of issues.
- Eager to be a team player
Physical DemandsThe physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of the job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Individual will need to sit (at times for extended periods) or stand as needed. May require walking primarily on a level surface during the workday. Reaching above shoulder heights, below the waist or lifting as required to file documents or store materials during the workday.
Additional InformationAll your information will be kept confidential according to EEO guidelines.