Description
The ideal candidate would be a highly-skilled certified auditor with attention to detail who is a pragmatic problem-solver who can facilitate problem resolution. The candidate must have a thorough understanding of the both US and EU requirements for quality compliance, e.g., cGMP for medical devices, Quality System Regulation 21 CFR part 820 and ISO 13485. Knowledge of 21 CFR as they pertain to primary drug containers would be a plus. In addition, quality management systems experience managing internal quality and supplier quality auditing functions for a medical device manufacturer would be beneficial.Essential Job Functions:
- Compliance auditing across all Unilife Quality Systems
o Manage internal audit program, conduct audits as required and work with pool of internal auditors to ensure compliance of Unilife's quality system and adherence to Unilife's internal audit schedule
o Perform and review supplier audits, produce supplier audit reports, and work with suppliers to improve supplier quality and resolve supplier quality issues
o Train internal and supplier auditors as required
- Execute Finished Product Release - Review finished product Device History Records to ensure compliance and execute finished product release in ERP system
- Oversee document control function and maintain regulatory standards library
- Lead supplier CAPA activities and act as a quality liaison with suppliers and customers when required
- Work with Supply Chain to develop and maintain supplier quality metrics (supplier score cards)
- Support Unilife's Non-conformance and CAPA program
- Assist the VP, CQ & RA with customer and notified body audits
- Performing any other tasks assigned by the VP, CQ & RA or as needed to continuously improve the functioning of the Corporate Quality and Regulatory Affairs Department
Education/Experience Required:
- A bachelor's degree in a scientific discipline and practical, hands-on knowledge of medical device auditing, along with a minimum of 5 years of experience in compliance auditing, quality assurance or quality engineering in a FDA-regulated industry is required
- In-depth understanding of quality auditing principles, CQA preferred
- In-depth understanding of the application of cGMP for medical devices, 21 CFR part 820, and ISO 13485 standard for medical devices and quality management systems is required
- Must have experience performing internal and supplier audits for a medical device manufacturer
- A basic understanding of statistics and root cause analysis tools to support and facilitate quality metric reporting and CAPA resolution is required
- Knowledge of or experience with drug cGMP, 21 CFR part is preferred
- Expertise in providing GMP and ISO 13485 training is highly desirable
- Will travel domestically and internationally to perform on-site evaluation of suppliers' Quality Management Systems and may provide training and assistance to suppliers as part of the validation and qualification of suppliers' processes
If this fantastic opportunity within a company that is about to undertake huge expansion sounds of interest you, please do send me your cv or call Andrew at Real Staffing .