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16 days old

Quality Assurance (QA) Inspector, San Diego, CA

Kelly Services
San Diego, CA 92108
**Quality Assurance (QA) Inspector, San Diego, CA**


**Responsibilities:**


+ Supports Quality Assurance Q.A. Incoming Inspection group activities necessary for assuring the quality and compliance of incoming materials against House Specifications.

+ Assists in planning, organizing, creating, performing, evaluating, reporting, storing or accessing documents and/or results for products, equipment, corrective actions, non-conformances, audits or environmental monitoring required to complete the process of related incoming inspection activities.

+ Responsibilities are to be carried out in accordance with established procedures, policies and all applicable FDA and ISO regulations.

+ Proficiency in understanding and interpreting FDA and ISO 13485 rules and regulations and their application at all levels throughout the organization, including the manner in which quality programs i.e. CAPA, NCMR, storage, labeling, equipment calibration, training, etc. are established, maintained and documented to ensure compliance with these rules and regulations.

+ Completes and maintains timely training on the departmental, safety, technical, recordkeeping and Quality Systems Regulations QSR aspects of the position.

+ Assists in writing, updating and maintaining Standard Operating Procedures SOPs and policies associated with the Q.A. Incoming Inspection group according to the Electronic Change Management ECM system.

+ When necessary, informs area managements of necessary changes to current methods and systems to ensure continuous improvement of the Q.A. Incoming Inspection process.

+ Helps establish and maintain effective work relations and communication within the Q.A. Incoming Inspection group.

+ Helps identify issues, concerns, etc. within the Incoming Inspection group that may have an overall effect on the efficiency, cohesiveness and teamwork within the Q.A. Incoming Inspection Group.

+ Completes and maintains accurate quality documentation and/or any associated documentation for all quality activities according to QSRs by Incoming Inspection personnel.

+ Assists with the interactions with the FDA and ISO notified bodies including inspections and/or audits, as necessary.

+ Assists with the correction and/or prevention of deficiencies.

+ Assists Q.A. Manager with ERP inventory transactions in an accurate and timely manner.

+ Assists in the investigation, analysis and implementation of corrective actions for compliance problems in conjunction with a manager/supervisor and/or the assistance of others.

+ Ensures supplies of materials, reagents and equipment required to meet quality activity schedules i.e. monthly Deionized Water System monitoring, monthly air and surface monitoring, etc. are available.

+ Alerts the manager of any material shortages, potential expiration dating problems, equipment requirements and/or other circumstances, which may cause delays in meeting assigned monitoring timeframes.

+ Completes work in compliance with established safety, ergonomic and environmental programs as required by OSHA regulations and corporate safety personnel.

+ Reports all safety hazards immediately and initiates actions to protect personnel from injury until a hazard is remedied.

+ Ensures work areas and equipment are kept in a clean and functional state in order to comply with QSR guidelines. Immediately reports all malfunctions, out-of-tolerance conditions or calibration expirations to manager/supervisor.

+ Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.


**Requirements:**


+ High School graduate with 3+ years of Quality Assurance experience.

+ In some instances, exceptions to the years of experience can be made based on management discretion.

+ Working knowledge of FDA regulations and ISO 13485 standard


**For Immediate Consideration, Apply Today! Questions? Email Alex at Aleo431@KellyScientific.com for More Info.**


**Why Kelly** **** **?**


Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire talented people just like you. Every day, we match science professionals with dream jobs that fit their skills and interestsits the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background/education in science, so we know a thing or two about the science market and how to get you noticed.


**About Kelly** ****


At Kelly, were always thinking about whats next and advising job seekers on new ways of working to reach their full potential. In fact, were a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live (plus, did we mention we provide a ton of benefits ?). Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.


Kelly is an equal opportunity employer committed to employing a diverse workforce, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity. Equal Employment Opportunity is The Law. (https://www.dol.gov/ofccp/regs/compliance/posters/ofccpost.htm)

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Posted: 2021-06-07 Expires: 2021-07-08

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Quality Assurance (QA) Inspector, San Diego, CA

Kelly Services
San Diego, CA 92108

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