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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