Glidewell Dental Careers

Description

• Executes the full lifecycle of audit program(s), including but not limited to developing audit schedule, leading and conducting audits, assessing and reporting results, managing timely responses, and following up on corrections, corrective and/or preventive action items, and verification of effectiveness.
• Conducts audits in a timely manner according to the audit schedule. Reviews containment actions, performs thorough investigations, determines root cause, and develops action and verification of effectiveness plans.
• Interprets recommendations, observations, and findings from audits to ensure corrective actions are appropriate and effective. Informs stakeholders of potential risks.
• Collects and analyzes data to measure effectiveness of audit programs relative to department goals and objectives.
• Partners with process owner to perform verification and assess effectiveness of audit action items.
• Maintains and regularly updates audit tracker to monitor audit status and progress.
• Develops quality and audit metrics and reports, such as PARETO charts and/or control charts, to track audit trends and effectiveness.  
• Coordinates and leads stakeholder meetings to ensure visibility into audit statuses and activities. Presents results to stakeholders for alignment and to identify improvement opportunities. 
• Participates in supplier audit as part of critical supplier selection and evaluation.
• Presents and distributes internal audit reports including action items from audit results.
• Coordinates and manages onsite audit preparations, including logistics and other audit readiness activities. Participates in third party audits.
• Escalates and supports audit process owner by issuing an audit, Corrective and Preventive Action (CAPA), and/or non-conformance report (NCR) extension request when applicable to prevent a past due record.
• Reviews and approves quality records for compliance, content, completion, accuracy, and relevancy to the subject matter. Ensures records adheres to all applicable procedures, guidance, regulations, and standard requirements.
• Reviews Quality System elements to assess its adherence to the criteria for management and control processes.
• Participates in improvement projects for the Quality Management System (QMS). 
• Coordinates and partners with impacted teams to provide guidance on manufacturing processes or quality systems compliance.
• Stays abreast of relevant domestic and international standards and regulations to monitor and ensure conformance.
• Acts as a liaison between internal audit and regulatory agencies, suppliers, and internal teams to facilitate clear and effective communication.
• Performs other related duties and projects as business needs require at direction of management. 

• Bachelor’s degree in related field, or any equivalent education and/or experience from which comparable knowledge, skills and abilities have been demonstrated/achieved.
• Minimum three (3) years of experience in quality systems within the medical device industry required.
• Minimum four (4) years of experience performing GMP/ISO internal audits required.
• Proficient knowledge of FDA 21CFR 820 Regulations.
• Proficient knowledge of International Organization for Standardization (ISO) 13485 Standard.
• Proficient knowledge of Canadian Medical Devices Regulation (CMDR) SOR/98-282.
• Proficient knowledge of Medical Device Single Audit Program (MDSAP).
• Previous experience developing and adhering to Good Manufacturing Practices (GMPs), Good Laboratory Practices (GLPs), and Standard Operating Procedures (SOPs) required.
• Previous experience in root cause analysis and corrective and preventive action methods required.
• Quality assurance experience in a manufacturing environment is a plus.
• Previous technical writing experience a plus.
• ASQ Certified Quality Auditor, ASQ Certified Biomedical Auditor, ASQ Certified Medical Device Auditor, or IRCA Certification preferred.

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 Glidewell!

In 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 [email protected]. Please indicate the specifics of the assistance needed.

Note to Current employees: Please apply through Employee Transfer Application to complete the transfer request form.