Quality Auditor

Quality Auditor
The requirements listed below under the job title are representative of the knowledge, skills, and/or abilities required to perform the duties of this position.
 

QUALIFICATIONS:  

Minimum education required:

A Bachelor’s degree is required, preferably in a science or technical discipline.


Minimum experience (number of month/years and type of work experience beyond formal education) required for competent performance:

At least 5 years of experience in a Quality, Manufacturing or Engineering function in medical device industry
At least 5 years of experience in a Quality, Manufacturing or Engineering function in medical device industry
Working knowledge of medical device regulations and standards: 21 CFR Part 820 QSR, ISO 13485, Brazil GMP, Canada Medical Devices Regulations SOR 98-282, Japan’s MHLW MO 169, EU MDR
Lead Auditor certification from an accredited / recognized organization (preferred)
Project management experience (preferred)
Certifications: Green Belt/Process Excellence, CMMI Lead Assessor, or other Quality Certifications (preferred)
Supervisor experience, talent development (preferred)
Strong written and oral communication skills as well as report writing, presentation and training skills
Proven leadership, teamwork, collaboration, and influencing skills to drive the right actions and enable adoption of best practices
Capability to interpret regulatory requirements in the light of current trends and business application
Ability to accomplish objectives in a timely manner with limited or without day-to-day supervision.
Good interpersonal skills; customer oriented
Demonstrated initiative and assertiveness
Strong problem solving and root cause analysis skills
Look for pragmatic solutions that balance risk/benefit for both short- and long-term success
Be open to diverse opinions and ideas. Active listening
Strong computer skills and use of software application(s), including MS Windows, MS Office (Word, Excel, PowerPoint)


Must be local to Irvine, CA office



 


JOB GOAL:
Conducts audits - planned and not planned - to verify the compliance with the government regulations and applicable standards, along with the company policies and procedures. Provides guidance or advice to the organization concerning the compliance as required.

 


RESPONSIBILITIES:



Assures that Quality System Audits comply with QSR/GMP and ISO requirements.
Conducts internal audits of the Quality System in order to verify the compliance with the government regulations and applicable standards along with the company policies and procedures. Conducts audits of good laboratory practices (GLP) as required.
Provides guidance or advice regarding the compliance with applicable standards and regulations
Conducts re-audits to deficient aspects and to implemented corrective/preventive actions as needed and required.
Assigns classifications to internal audit observations and document the audit results in written reports that are distributed and reviewed by the appropriate management.
Monitors the effectiveness of the corrective actions documented on the observation responses.
May be lead auditor of auditors’ team, technical experts, trainee auditors, and/or volunteer auditors.
Reviews appropriateness of responses to audit observations, also, acts as consultant of other areas that are not audited by him/her, providing advice on audit observations response.
Maintains the audit reports files, re-audits files and the responses to the audits performed.
Escort to external auditors, government agencies representatives or those required by management during the execution of the audit as applicable.
Conducts audits to other client sites as required per the management.
Complies and review metrics related to Compliance and communicate them to the site management and Franchise. Prepares information for the Management Review meetings.
Participates in the formulation of Policies and Regulatory Procedures in compliance with the standards and applicable local, state and federal regulations through the development of Franchise Documents.
Keeps updated on government regulations and applicable standards changes through publications, participation in seminaries or collaboration with organizations.
Responsible for communicating business related issues or opportunities to next management level
For those who supervise or manage a staff, responsible for ensuring that subordinates follow all Company guidelines related to Health, Safety and Environmental practices and that all resources needed to do so are available and in good condition, if applicable
Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures
Performs other duties assigned as needed





As part of our promise to talent, Kelly supports those who work with us through a variety of benefits, perks, and work-related resources. Kelly offers eligible employees voluntary benefit plans including medical, dental, vision, telemedicine, term life, whole life, accident insurance, critical illness, a legal plan, and short-term disability. As a Kelly employee, you will have access to a retirement savings plan, service bonus and holiday pay plans (earn up to eight paid holidays per benefit year), and a transit spending account. In addition, employees are entitled to earn paid sick leave under the applicable state or local plan. Click here for more information on benefits and perks that may be available to you as a member of the Kelly Talent Community.Why Kelly® Science & Clinical? Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire industry experts just like you. Our team creates expert talent solutions to solve the world’s most critical challenges. Every day, we match science professionals with dream jobs that fit their skills, interests, and career goals—it’s the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background and education in science, so we know a thing or two about the science market and how to get your expertise noticed.






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