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Quality manager

CV-Library

Posted on Oct 20, 2021 by CV-Library

Gloucestershire, United Kingdom
Engineering
Immediate Start
£55k - £65k Annual
Full-Time
My client is currently looking for a Quality Assurance manager to assist them in effectively managing quality processes in a growing manufacturing business.

The incumbent has the ability to take strategic direction and establish efficient and compliant processes throughout the organisation and has strong communication at all levels. This position is to manage the quality assurance team to include incoming inspection, quality assurance, quality compliance, and quality engineering. Must have the ability to liaise with customers and auditors, ensuring compliance and corrective measures meet specifications and regulations

Develops the annual quality Improvement plan and measures progress against the plan
Ensuring our Quality Management Systems meet appropriate standards including considerations within ISO 13485:2016, MDR, MDSAP and 21 CFR 820.
To ensure compliance of GMP with respect to medical device manufacturing.
To facilitate and manage external and internal audits in line with QMS
Review and Conduct Management Review Meeting (MRM).
Build proactive relationships with key customers and suppliers
Manage customer complaints, nonconforming material, scrap, and quality trends
Manage: the approval of artworks of labels, barcodes, label information, and packaging compliance with international standards.
Develop clear training plans across the business, in line with Quality strategy.
Responsible for the management and appropriate reporting system per vigilance and MDR monitoring systems.
Working with the Senior Management Team in implementing and overseeing processes and procedures
Maintain appropriate documentation for quality compliance in Q Pulse and monitoring compliance of document control in manufacturing
Liaises with suppliers to resolve quality concerns and coordinate internal actions where necessary.
Employ quality assurance methodologies in support of engineering, manufacturing and regulatory functions
Define and Implement a proactive approach to quality management, leveraging people and technology
Develop and implement quality control and inspection procedures for receipt and control of incoming materials, in-process materials and final product acceptance activities
Define and set quality objectives linked with the business and operations strategy
Establish and maintain test instrument calibration procedures and maintenance schedules
Establish quality assurance and quality control inspection and testing procedures that meet regulatory compliance
Active participant in all stages of design development, Verification and Validation testing and design control activities, ensuring quality assurance considerations and requirements met
Responsible for developing and maintaining sterilisation validation and material biocompatibility activities
Participate in the review of product requirements, design requirements, software requirements specifications, and functional specifications
Assist in Risk Management activities, FMEAs and ensure compliance to standards and regulations
Assist in the failure investigation of product complaint and CAPA activities
Lead preparation for and conducting of regulatory audits and inspections
Review and update product design and maintain change control records
• Demonstrated experience with leading teams

• ILM Level 4 or equivalent

• A bachelor’s degree in natural science, engineering, medical technology or equivalent

• Minimum 2 years’ experience in medical device regulatory/quality role

• Sound understanding of QMS, ISO 13485, MDD, MDR

Reference: 214961958

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