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The purpose of this role is to manage the Quality Management System in Touch Biotechnology. This role is to ensure that the manufacturing and distribution of Artisan Labs products are carried out according to Good Manufacturing Practices (GMP) and Artisan Labs Standard Operating Procedures (SOPs).

The role of Quality Manager is critical to the success of the business by way of ensuring that product supplied, and processes undertaken are of the highest standard and meets all technical requirement and specifications. This role constitutes the “Authorised Person” as defined in cGMP. 

Key Responsibilities:

·        Develop, review, update, and enforce quality assurance procedures in line with

company quality policies.

·        Manage Quality Management System (QMS) tasks, including document control, design

control, supplier quality management, NCR/CAPA, customer feedback, and post-market

surveillance.

·        Create and review quality assurance documents, handle requests, and conduct internal

and external audits.

·        Assist in the management review process of the QMS.

·        Maintain effective record-keeping practices across the QMS.

·        Assist in preparation of SOPs, work instructions and other quality documentation.

·        Document control and change management

·        Conducting internal audits

·        Review of batch records and release process

·        Develop and review documentation related to product quality and processes.

·        Approve specifications, sampling instructions, test methods and other quality control

procedures

• Ensure that all necessary testing is carried out.

Qualifications:

·        Qualifications in Science or biomedical or bio engineering (Mandatory)

·        Qualifications in chemistry / biochemistry (Optional)

·        Certificate in Quality Management System ISO13485 or MDSAP (highly desirable)

·        Qualifications in project management (desirable)

Selection Criteria - Skills /Attributes:

·        Minimum of 3-4 year's experience in the medical device industry, or at least 6 years in a

relevant or comparable business role.

·        Demonstrated experience in quality and/or regulatory roles, preferably within a medical

device company, including those with Software as a Medical Device (SaMD) and In-vitro

Diagnostic (IVD)

·        Proven track record in developing and managing Quality Management Systems (QMS).