Auditor-QA Medical Device
Invacare Corporation - Elyria, OH

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The QA auditor performs and reports internal/supplier quality audits as to provide an independent assessment of the compliance posture of the operation, and the effectiveness and adequacy of the quality system, procedures and practices which governs the operation. The individual carries out internal/supplier quality audits against Medical Devices Regulations and Standards, Corporate Quality Manual, Corporate Policies, Divisional and Plant Procedures. The QA auditor also manages external audits (FDA, ISO and other regulatory authorities)

ESSENTIAL FUNCTIONS:
Schedule and conduct internal audits, support external agency inspections (e.g. FDA, EMA, ISO and others), and external vendor/supplier audits and inspections

Assist in the management of external audits and site audit readiness

Examine and interpret documentation for new and current compliance procedures and regulatory enforcement trends\actions

Generate or coordinate the generation of audit reports brought to the attention of personnel having the responsibility of the area audited

Maintain a follow up system for unresolved issues until a corrective/preventive action is taken

Analyze Audit Reports answers for corrective and preventive action effectiveness

Maintain expert knowledge of regulations, company procedures, auditing, and quality principles

Maintain management aware of the non-compliance issues found during internal assessments. Identify regulatory risks within the plant

Required Skills

Required Experience

Bachelors degree in engineering or science

Industrial medical device experience e.g. as Product Designer / Product Development Scientist / Project Manager / Engineer / Regulatory Affairs / Quality Assurance

A minimum of 3-5 years of experience auditing and/or managing suppliers in an FDA medical device regulated industry and ASQ- CQA certification is required

Knowledge of regulations for medical devices (21 CFR 820 and ISO 13485)

Organized and details oriented; proven ability to meet deadlines

Strong analytical skills; verbal, and written communication skills

Ability to work individually and as part of teams

Computer System, Window Microsoft– Office (Word, Excel, PowerPoint), Good Documentation Practices, CAPA, Validations and Statistic (Sampling Plan & Tools of Data Analysis) knowledge and application

Minimum of 30% travel

PREFERRED EXPERIENCE, SKILLS & QUALIFICATIONS

Masters degree in engineering or science

User experience with quality systems management software

International audit experience

Knowledge of 21 CFR 211

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