Quality Manager

Job Title: Quality Manager Location: Marlborough, MA ROLE SUMMARY We are currently looking for a Quality Manager to join our Quality Department based in Marlborough, MA. You will be responsible for ensuring the ongoing maintenance of a robust and compliant quality management system across the Optos business thus assuring the consistency and quality of products, process and services through effective supplier management, goods-in inspection and production oversight and support. ESSENTIAL DUTIES AND RESPONSIBILITIES • Assure cGMP compliance for the Optos Inc. NA Operations. • Assure electronic quality management system meets requirements and is 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 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 Inc. 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. • 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. MINIMUM QUALIFICATIONS • 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). BENEFITS At Optos, we offer a highly competitive compensation and benefits package. • Eligibility for company bonus program. EQUAL OPPORTUNITIES EMPLOYER We are an equal opportunities employer and welcome applications from all suitably qualified persons regardless of their race, sex, disability, religion/belief, sexual orientation, age or protected veteran status. If you feel you have the necessary skills and experience and want to join a great team, please click on the Apply button! Apply Job!