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!