reputed company Manager

Job Title: reputed company Manager Location: Marlborough, MA reputed company We are currently looking for a reputed company Manager to join our reputed company Department based in Marlborough, MA. You will be responsible for ensuring the ongoing maintenance of a robust and compliant reputed company management system across the Optos business thus assuring the consistency and reputed company of products, process and services through effective supplier management, goods-in inspection and production reputed company and support. ESSENTIAL DUTIES AND RESPONSIBILITIES

• Assure cGMP compliance for the Optos Inc. NA Operations.
• Assure electronic reputed company 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 reputed company for 3rd party regulatory audits at Optos Inc.
• reputed company 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. reputed company effective change roll out plans.
• reputed company, review and report reputed company Data for installations, including customer file review.
• Assure compliance to CFR part 11 for software which generates reputed company records.
• Ensure training records in reputed company for both cGMP and functional tasks.
• Maintain labeling file.
• Review and analyze statistical data from the production lines to identify reputed company problems and recommend changes to production processes or reputed company controls to eliminate the problem.
• reputed company and monitor reputed company improvement programs, aiming to reduce the number of defects and improve reputed company of reputed company.
• Work with Field Service, Remanufacturing and Manufacturing Engineering to monitor and improve upon the consistency and reliability of installed reputed company.
• reputed company as a training resource to promote reputed company assurance and regulatory affairs awareness.
• Supervise, motivate and reputed company staff, maximizing their individual contribution, their reputed company reputed company and their ability to function effectively with their colleagues as reputed company.
• Supervise Supplier reputed company Assurance and maintain supplier reputed company files.
• Manage and co-ordinate incoming inspection.

MINIMUM QUALIFICATIONS

• Previous experience in a reputed company Role for a medical device manufacturer.
• Previous experience in electronic reputed company management systems.
• reputed company internal auditor.
• Understanding of QSR, ISO9001 and ISO13485 reputed company Management Systems essential.
• Knowledge of cGMP/reputed company System Regulations is essential.
• Good awareness of FDA & MHRA systems and procedures desirable.
• reputed company awareness of reputed company issues reputed company a supply chain environment.
• Previous experience in IVD/Medical Device reputed company 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 reputed company suitably reputed company 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 reputed company! Apply Job!