RESPONSIBILITIES
- Assure cGMP compliance for the NA Operations.
- Assure electronic quality management system meets requirements and utilised to its full potential.
- Maintain procedures for complaint handling and Medical Device Reporting to FDA. Run an effective CAPA system.
- Maintain recall procedures which are effective for US distribution.
- Assure satisfactory outcomes for 3rd party regulatory audits
- Attain ISO 13485:2003 accreditation for the US site.
- Responsible for internal audit schedule creation and adherence.
- Manage the calibration requirements by providing necessary information to the appropriate departments.
- Maintenance of the Device Master Record for the complete product.
- Robust configuration management control for the device. This includes change control and any required verification and validation activities. Develop effective change roll out plans.
- Gather, review and report Quality Data for installations, including customer file review.
- Assure compliance to CFR part 11 for software which generates quality records.
- Ensure training records in place for both cGMP and functional tasks.
- Maintain labelling file.
- Review and analyze statistical data from the production lines to identify quality problems and recommend changes to production processes or quality controls to eliminate the problem.
- Develop and monitor continuous improvement programs, aiming to reduce the number of defects and improve levels of quality.
- Work with Field Service, Remanufacturing and Manufacturing Engineering to monitor and improve upon the consistency and reliability of installed units.
- Act as a training resource to promote quality assurance and regulatory affairs awareness.
- Supervise, motivate and develop staff, maximizing their individual contribution, their professional growth and their ability to function effectively with their colleagues as a team.
- Supervise Supplier Quality Assurance and maintain supplier quality files.
- Manage and Co-Ordinate incoming inspection.
REQUIREMENTS
- Previous experience in a Quality Role for a medical device manufacturer.
- Previous experience in electronic quality management systems.
- Qualified internal auditor.
- Understanding of QSR, ISO9001 and ISO13485 Quality Management Systems essential.
- Knowledge of cGMP/Quality System Regulations is essential.
- Good awareness of FDA & MHRA systems and procedures desirable.
- Sound awareness of quality issues within a supply chain environment. .
- Previous experience in IVD/Medical Device related industry is desirable.
- Excellent interpersonal skills with the ability to influence.
- Good computer skills (MS Office applications).
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