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Internal Auditor - Irvine, United States - Glidewell Dental
Description
Understands and follows Prismatik's Quality Manangement System per training.Understands and complies with rules and Company policies.
Manages the internal audit lifecycle including but not limited to planning, generating the audit schedule, execution, reporting, managing response, and follow-up on commitments/CAPA.
Conducts internal audits and participates in third party audits.Reviews and monitors documentation, as assigned, to ensure compliance with relevant standards, regulations, and guidance documents.
Coordinates, liaises, and participates with internal teams to provide guidance on manufacturing processes or quality systems compliance.
Stays abreast on relevant domestic and international standards and regulations in order to monitor and ensure conformance.
Analyzes all elements of the Quality System and judges their degree of adherence to the criteria for management and control processes.
Collects and analyzes data to evaluate department goals and objectives for the internal audit process.Performs verification and effectiveness check of the action items implemented by process owner.
Maintains the Internal Audit database.
Participates in supplier audit as part of critical supplier selection and evaluation.
Interprets recommendations, observations, and findings from the result of the audit to ensure that corrective actions are appropriate and effective.
Presents and distributes internal audit reports including action items from internal audit results.Participates in improvement projects for the Quality System, as needed.
Performs other related duties and projects as business needs require at direction of management.
Education and Experience:
Bachelor's degree in related field or equivalent experience.
Minimum of three (3) years of experience in quality systems within the medical device industry.
Minimum four (4) years experience performing GMP/ISO internal audits.
Training in Quality Systems including relevant Regulations and Standards.
Special Requirements/Certification:
ASQ Certified Quality Auditor, ASQ Certified Biomedical Auditor, ASQ Certified Medical Device Auditor OR IRCA Certification preferred.
Pay:
$23.90-$34.36/hr
Glidewell Laboratories is the industry leader in dental technology due to our agility, speed, and cutting edge technology. We work in a fast-paced and highly sought-after employee-friendly work environment.
Behind all of this success is an amazing group of people who are passionate about bringing innovation to the marketplace, while providing quality and affordability to better the lives of people all over the world.
If you share in our passion for teamwork and a vision for excellence, let's talk about a rewarding career at GlidewellIn addition are the following generous employee benefits: Medical, Dental, Vision, 401K with company match, company-paid life insurance, additional onsite dental services, vacation, holiday, and sick time, employee gym (with fitness classes and meditation room), employee medical/wellness center (with massage therapy and acupuncture), two company subsidized cafes, Internet cafes, employee lounges with big screen TVs, game tables, fun company sponsored events, a diverse work environment with over forty nationalities represented, and much more
Glidewell Laboratories is an Equal Opportunity Employer and prohibits any kind of unlawful discrimination and harassment.
We are committed to the principle of equal employment opportunity for all employees and to provide employees with a work environment free of discrimination and harassment on the basis of race, color, religion, national origin, sex, age, physical or mental disability, veteran status, sexual orientation, gender identity, genetic information, or any other status protected by the statutes, rules, and regulations in the locations where it operates.
If you are an individual with a disability and need a reasonable accommodation to assist with your job search or application for employment, please contact us at Please indicate the specifics of the assistance needed.
Note to Current employees:
Please apply through Employee Transfer Application to complete the transfer request form.
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