Driven by a commitment to research, quality and service, PDI, Inc. provides innovative products, educational resources, training and support to prevent infection transmission and promote health and wellness. Encompassing 3 areas, our Healthcare, Sani Professional and Contract manufacturing divisions, we develop, manufacture and distribute leading edge products for North America and the world.
We have several locations across the US and are looking for new Associates to join our team!
The Quality Management System (QMS) Audit Manager is responsible for and has the authority to establish, and maintain the effectiveness of the internal audit program. This role will also lead, conduct, and support the external supplier audit program as required. The Audit Manager provides global management of quality system audits of facilities, products, and processes against medical device regulations and standards. The Audit Manager provides training, and guidance for the QMS Audit Team when applicable. This role assures compliance with global quality systems regulation requirements including, but not limited to, the FDAs Quality System Regulations (21 CFR 210, 211, 820), ISO 13485, ISO 9001, the Canadian Medical Device Regulations and the EU Medical Devices Directive. The Audit Manager provides leadership, and development to the audit program for the implementation of quality system. Ensures harmonization of company Quality Management System audits, and drives continuous improvement of Corporate Internal Audit by maintaining expert knowledge of regulations, company procedures, auditing and quality principles.
ESSENTIAL FUNCTIONS AND BASIC DUTIES
Prepare and maintain the Internal Quality Audit Schedule, including preparing the audit agenda with cross functional groups, conducting audits, preparing auditing reports, following up the status of corrective actions, and closing the audits. Ensure Internal Audits are conducted per the published Audit Schedule, and Internal Quality Audit files are well maintained. Collaborate with subject matter experts to conduct external audits on suppliers, labs and 3rd party manufacturers as required. Plan and perform Quality Management Systems audits of departments, and functions against medical device, quality system regulations, and standards to achieve corporate compliance objectives. Ensure that the response forms are initiated to address the audit findings, and communicate with management and auditee(s). Determine when findings and audits are closed OR require escalation, and risk level review with the Vice President of Quality. Ensure that Corrective And Preventative Actions (CAPAs) generated by internal audit findings are audited for effectiveness as supporting audit evidence, where applicable, and that such audits are documented. Monitor, and report the effectiveness of audits including corrective action plans, effectiveness checks, and risks. Provide support in the development, and monitoring of the effectiveness of the Quality Management System throughout the organization including measurement, analysis and trending of policy and objectives implementation, identification of continuous improvement opportunities, training and management review. Assist in site audit readiness activities, and provide support during customer and regulatory body audits. Assist with writing and review of procedures and instructions for development of the Quality Management System as required. Develop, and maintain a Certification/Qualification program for internal auditors. Interface with Site Audit Leads to evaluate, and implement Global Best Practices. Participates and provides feedback into Management Reviews, and other QA related meetings. Consistently demonstrates good judgment and critical thinking in the performance of Compliance activities.
DATA ENTRY & INTEGRITY: a. Prepare, and maintain the Internal Quality Audit Schedule, including assignment of auditors if applicable, conducting audits, follow up the status of findings, writing and review report, and audit closure. b. Lead and manage external supplier audits as required.
REPORTING & ANALYSIS: a. Management Review, Internal Audit Team (IAT), and Quality Review Committee (QRC) matric reporting b. Monthly Analysis and scheduling
CLIENT ENGAGEMENT: a. Audit Remediation b. Fair Presentation with cross functional auditee
TECHNICAL EXPERTISE: a. Maintenance of standards including statutory and regulatory law (i.e. GMP, ISO, and local government.) b. Requirements not specified by the customer, but still needed.
SPECIAL PROJECTS: a. Audit Remediation b. Third party Audit support
PERFORMANCE MEASUREMENTS 1. On time completion 2. Robustness of program 3. Training and certification compliance 4. Values centered execution
EDUCATION/CERTIFICATION: 4-year technical or scientific degree or equivalent experience, or exposure to Quality Management Systems, processes and procedural internal or Supplier audits to 21 CFR Part 210, 211, 21CFR 820, ISO 13485, and other applicable standards to ensure corporate and regulatory compliance
REQUIRED KNOWLEDGE: Proficiency in Microsoft Office Suite, SmartSolve and Master Control modules is preferred.
EXPERIENCE REQUIRED: Bachelor's Degree in a discipline that is relevant to QA or equivalent QA certifications. 5 years relevant experience Lead Auditor certification preferred. Over 5 years of experience implementing, interpreting, and providing guidance on domestic and international regulations for medical devices: FDA 21CFR210, 211, 820, ISO 9001 and ISO 13485 standards, MDD, etc. Must have experience with international regulations for medical devices. Must have medical device experience, knowledge of Pharmaceutical Regulations desired. Certified Quality Auditor/ISO lead Auditor Certified to conduct Quality System audits against standards and regulations such as 21CFR210, 211, 820 and ISO 13485.
SKILLS/ABILITIES: Excellent interpersonal and communication skills; ability to work in cross-functional teams. Strong analytical skills in order to analyze processes and provide solutions. Flexibility to work in a high paced environment with strong prioritization skills. Exhibits a high degree of integrity, initiative and motivation. Knowledge of statistical methods and sampling techniques
INTENT AND FUNCTION OF JOB DESCRIPTIONS
Job descriptions assist organizations in ensuring that the hiring process is fairly administered and that qualified employees are selected. They are also essential to an effective appraisal system and related promotion, transfer, layoff, and termination decisions. Well-constructed job descriptions are an integral part of any effective compensation system.
All descriptions have been reviewed to ensure that only essential functions and basic duties have been included. Peripheral tasks, only incidentally related to each position, have been excluded. Requirements, skills, and abilities included have been determined to be the minimal standards required to successfully perform the positions. In no instance, however, should the duties, responsibilities, and requirements delineated be interpreted as all-inclusive. Additional functions and requirements may be assigned by supervisors as deemed appropriate.
In accordance with the Americans with Disabilities Act, it is possible that requirements may be modified to reasonably accommodate disabled individuals. However, no accommodations will be made which may pose serious health or safety risks to the employee or others or which impose undue hardships on the organization.
Job descriptions are not intended as and do not create employment contracts. The organization maintains its status as an at-will employer. Employees can be terminated for any reason not prohibited by law.
* The salary listed in the header is an estimate based on salary data for similar jobs in the same area. Salary or compensation data found in the job description is accurate.