- Leader 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-conformances
- Re-writing procedures and work instructions as required to address the audit non-conformances
- Facilitating teams to address non-conformances
- Acts as a quality resource for all auditees
- Responsible 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.
Required Education
Bachelor's degree required
Required Skills & Experience
- 5-7 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 time
- Must possess Good Communication skills communication skills, tact and diplomacy
- ISO 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.
Preferred Skills, Experience & Education
- Experience in medical device industry
Joerns Healthcare is an Equal Opportunity Employer