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!

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