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Quality System Auditor

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Arlington, TX

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Job DescriptionnJoerns Healthcare is a leading national distributor of therapeutic support surfaces, bariatric care equipment, negative pressure wound therapy systems, and safe patient handling solutions. We serve special patient handling needs across the entire continuum of care, including acute care hospitals, long term acute care hospitals, skilled nursing facilities, rehabilitation facilities, and hospice centers.We continually strive to provide the most exceptional service, the most affordable products, and the most innovative patient care solutions to our customers. We are currently searching for skilled, self-motivated and dedicated professionals to add to our team. We offer hands on training, benefits and an outstanding work environment.rrrrrrrrrrrrrrBenefits rrrrrrrrrrAt Joerns Healthcare, each eligible employee receives a competitive total compensation package including Medical, Dental, Vision, Life Insurance and Short Term Disability. Our employees also receive Paid Vacation and Holidays. Please note that benefits may vary by site.rrrrrrrrrrrrrrPosition Summary rrrrrrrrrrThe Quality System Auditor is primarily responsible for leading the internal quality system audit program and all associated audit procedures.rrrrrrrrrrrrrrMajor Duties & Responsibilities rrrrrrrrrrLeader of the internal quality system audit program, responsible for all associated procedures, the audit schedule, hosting 3rd party audits and the overall quality system audit process.Creates the internal audit schedule to comply with the requirements of ISO-13485.For each individual audit, creates the audit checklist thru review of external standards ex. ISO-13485, 21CFR Part 820 etc., and review of company procedures (Joerns or Supplier) in order to verify quality system adequacy and compliance to the applicable standards.  Conducts the internal quality system audits for all ISO Certified Joerns locations to the established audit schedule.Generate audit reports and corrective action(s) based on any audit non-conformances identified during the audit(s).Responsible for ensuring that the audit corrective actions are answered in a timely manner, closed out and effective, this includes but is not limited to:Writing new procedures and work instructions as required to address the audit non-conformancesRe-writing procedures and work instructions as required to address the audit non-conformances Facilitating teams to address non-conformancesActs as a quality resource for all auditeesResponsible for closure of each audit based on verification of completion of all audit requirements. Facilitates the effective and timely communication of audit results, trending, and data mining.Facilitates the HARM process per ISO-14971 Risk Management for Medical Devices and established procedures.Owner and facilitator of the 8D Corrective Action process.Works closely with the product development group in the generation of control documents such as Quality Plans, FMEA’s, Design Verification and Validation Plans.May perform external quality system audits at Joerns Suppliers.Will assist Supplier Quality to ensure that supplier corrective actions are answered in a timely manner, closed out and effective, this includes but is not limited to:Working with the supplier to write new or re-write existing procedures and work instructions as required to address the audit non-conformances;Facilitating cross-company teams to address non-conformances;Closure of supplier audits based on verification of completion of all audit requirements. Facilitates the effective and timely communication of audit results and trending as part of the overall supplier scorecard process.Support Receiving Inspection activities as required.rrrrrrrrrrrrrrRequired Education rrrrrrrrrrBachelor's degree requiredrrrrrrrrrrrrrrRequired Skills & Experience rrrrrrrrrr5-7 years’ experience in a regulated industry conducting internal audits and /or external audits; or an equivalent combination of education and experience which has provided both theoretical and practical knowledge in the field.Must be willing to travel up to 30% of the timeMust possess Good Communication skills communication skills, tact and diplomacyISO certified auditor or lead auditor or ASQ Certified Quality Auditor (CQA).Ability to read and interpret documents such as safety rules, operating and maintenance instructions, and procedure manuals.  Ability to write routine reports and correspondence. Ability to speak effectively before groups of suppliers or employees of organization.rrrrrrrrrrrrrrPreferred Skills, Experience & Education rrrrrrrrrrExperience in medical device industryJoerns Healthcare is an Equal Opportunity Employer

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