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Title: Quality Control Inspector
Hiring Organization: Connexon Systems & Engineering
Our client is seeking: Quality Control Inspector for the Operations and Deigning medical devices including providing inspection results, and as needed performing root cause analysis and resolutions
Compensation, Benefits, and Employment Type
- Duration – Permanent
- Pay rate: 47-55K
- Job Location: Danvers, MA
- Job# bh11534
- Date Posted: 7/17/2020
ESSENTIAL DUTIES AND RESPONSIBILITIES include the following. Other duties may be assigned.
- Assist in maintaining and improving the quality management system documentation and processes to meet U.S. 21 CFR 820 (FDA QSR) and ISO 13485 requirements
- Support with initiatives in the quality department to meet goals and objectives and ensure compliance with regulations
- Perform incoming inspection on Mechanical, Electro-mechanical and Cable assemblies to a quality data plan using various inspection tools or test fixturing
- Support incoming production testing done on supplier provided printed circuit assemblies
- Execute re-verification needs on assemblies that have been internally repaired or reworked by the respective supplier
- Tabulate and trend repaired in house items that are performed by production personnel
- Maintain pareto charts as needed for respective data being monitored (e.g. inspection failures, re-verification activities, etc.)
- Originate nonconforming material reports for failed material requiring disposition
- Support the efforts of the nonconforming material process
- Review Device History Records for completeness
- Execute Internal Audits and Supplier Audits per schedule
- Release or modify new or existing quality related procedures and provide training when needed
- Assist in supporting special projects for new products
- Perform other duties and functions as needed by Management
- Promote teamwork and collaboration within the quality function and with other functional areas
- Work independently with minimal supervision and as part of team
- Keep knowledge of all Samsung products up-to-date
- Attend/complete all required trainings
- Follow all company policies regarding travel, expenses, meetings, and meals
- Manage time effectively; prioritize and make good business judgments and decisions in relationship to efficiency, effectiveness
- Required to wear dosimeter when in direct contact with radiation emitting devices
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. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Education & Experience
- Bachelors Degree in Engineering or Quality related field preferred
- 3+ years of related experience
- Excellent written, oral, and documentation skills
- Knowledge of Statistical Process Control, ISO 13485, FDA QSR, MS Office (Excel and PowerPoint), Windows
- Skills and expertise for creating and revising SOPs.
- Travel as needed
- In compliance with federal law, all persons hired will be required to verify identity and eligibility to work in the United States and to complete the required employment eligibility verification document form upon hire
Computer & Analytic Skills
- Must be able to assemble facts from various areas, analyze data, and provide informed recommendations to management
- Must be able to work with minimal supervision, take charge of projects, and work effectively in a demanding, fast paced environment
- Must be excellent with technology, be able to present using a laptop computer, and be able demonstrate proficiency with MS Office package, including Excel, Word, and PowerPoint; as well as Outlook and Internet Explorer
- Occasionally lift and /or move up to 80 pounds
- Frequently required to sit; use hands to finger, handle, or feel; reach with hands; and talk or hear
- Must be able to sit for long periods of time
- The noise level in the work environment is usually mild.
- Specific vision abilities required by this job include Close vision, Distance vision, Peripheral vision, Depth perception and Ability to adjust focus
- Interaction with x-ray devices; for this reason strict safety and tracking programs are in place, requiring the utilization of dose monitoring equipment either full time or as necessitated by situation
- High attention to detail
- Understanding of terminology and ability to share and communicate effectively within the group
- Ability to organize and prioritize tasks resulting in consistent productivity
- Ability to function within and support a team environment and build strong working relationships
- Dependable and punctual
- Ability to meet accuracy and productivity goals
- Good problem solving skills, ability to evaluate situation and prioritize factors in decision making
- Self-motivated, utilize available resources for self-improvement and development
- Flexible: able to follow directives and accomplish tasks outside of normal duties
Please use the apply button to submit your resume for consideration. A Connexon Representative will contact you immediately.
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