MicroAire Surgical Instruments, LLC. is a fast-growing medical device company seeking an Internal Auditor with experience performing quality systems audits within a medical device company. MicroAire is one of four companies within Colson Medical, LLC., the medical group ofMarmon Holdings, Inc., under Berkshire Hathaway, Inc., a Fortune 100 company.
This position is principally responsible for performing all or the majority of audits for the Internal Auditing program across all QMS areas. The purpose of these audits are to ensure compliance to all applicable regulatory standards (e.g., 21 CFR 820, EU MDR, MDSAP, and others), MicroAire procedures, and MicroAire’s Internal audit schedule. They also contribute to ensuring and/or improving overall Quality strategy, policies, processes, standards and systems. The individual must be strongly focused on regulatory compliance, proper auditing and investigation, and good documentation practices.
ESSENTIAL DUTIES & RESPONSIBILITIES
Administration and maintenance of the Internal Audit System:
Under the direction of the QS Engineer, performs essential duties and responsibilities within the Internal Audit system, including pre-audit meetings, performance of audits (as an audit team member, sole auditor or Lead auditor for others), generation of audit reports, post-audit meetings, assigning of audit observations, reviewing/ approving responses to audit observations (in association with the QS Engineer), and the monitoring and closing out audit observations.
May assist in training/guidance to other auditors.
Supports any subsequent CAPA that is generated from an Internal Audit, as needed/required.
Identifies and/or advises on potential improvements to the Internal Audit System.
Provides data/analysis/key metrics from Internal Audits as needed/requested Answers any questions on the Internal Audit program from Regulatory Bodies, as needed/ requested
Provides QA Support to other areas of the QA/RA dept. as needed/requested
EDUCATION & EXPERIENCE
Education Requirements: Bachelor's Degree in science, engineering, or related field.
Experience Requirements: Minimum 2 – 5 years of related quality systems auditing in the medical device industry; experience in quality engineering, quality assurance, regulatory affairs, or change control, is preferred.
JOB KNOWLEDGE, SKILLS & ABILITIES
Good verbal and written communication skills; excellent attention to detail.
Good interpersonal and organization skills.
Ability to apply basic scientific reasoning to resolve technical problems.
Proficiency in Microsoft Office and other job associated software.
Understands the key concepts of QMS regulatory requirements, auditing, and elements of root cause analysis, Corrective Action, and Preventive Action.
MicroAire is a manufacturer and distributor of powered surgical instruments, sterile-packaged disposable orthopaedic accessories, SmartRelease-ECTR, PAL power-assisted liposuction, and Endotine bioabsorbable implants. MicroAire is a team dedicated to enhancing quality of life: For Surgery…For Life.
MicroAire is located in beautiful Charlottesville VA. home of University of Virginia and two large hospitals, Charlottesville is consistently ranked as one of the best places to live in America. For more information and to apply for this position visit our website at www.microaire.com (EEO)