To assure that Optos Inc. in North America (NA) meets their compliance obligations with respect to the US Food and Drug Administration Quality System Regulation. The System QA/RA Manager is the Management Representative for Optos NA. Establish a World Class benchmark to measure Optos’s progress.
Assure cGMP compliance for the Optos Inc. NA Operations.
Assure electronic quality management system meets requirements and utilized 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 at Optos Inc.
Attain ISO 13485:2003 accreditation for the US site.
Responsible for internal audit schedule creation and adherence.
Manage the calibration requirements for Optos NA (e.g. toolboxes) 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 labeling file.
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.
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).
If you feel you are qualified for this challenging role, please submit your resume to employment@ none optos.com . Optos is an Equal Opportunity employer.