Quality Assurance Associate in City of London

This is a Quality Assurance role NOT a Software role!

(Please read the job description carefully before applying, thank you)

Primary Objectives:

The Quality Assurance Associate is responsible for helping to maintain and improve the DnaNudge Quality Management System as part of the Quality team by identifying potential improvements and efficiencies and helping to develop, revise and implement Quality procedures and policies.

The Quality Associate will work with the Quality team to ensure products and design and development of future products are compliant with the requirements of ISOs 9001, 27001, 13485.

Major Responsibilities:

• Support strategy to enhance and maintain DnaNudge’ s QA and regulatory programmes to meet required standards and regulations for products.
• Ensure the quality policy and processes support the strategic business plans to advance the company’s mission and objectives.
• Work in close collaboration with all company departments to maintain compliance of all regulatory requirements.
• Participate in the execution and support of internal and external regulatory audits and inspections.
• Support the maintenance of DnaNudge QMS program ensuring all processes are compliant to the relevant standards.

· Manage some DnaNudge documentation associated with the QMS where required

· Perform initial quality reviews of identified nonconformities.

· Support the Change Control Process

· Maintain knowledge of the site policies and procedures

· Perform local area & local system audits where required

· Manage the documentation process

· Assist in the reporting of all metrics associated with the QMS

· Proactive generation and timely review/implementation of change controls in conjunction with other personnel

· Ensure that any documents presented for QA approval/checking are complete.

• Support a training program to ensure all employees are familiar with the relevant company processes.
• Support the maintenance of files for a range of quality records as required.
• Manage batch release of products

· In order to meet business needs and demands, you may occasionally be required to work hours in excess of your designated schedule. All employees are expected to demonstrate a reasonable level of flexibility to such requests wherever possible. The Company reserves the right after due notice and consultation, to amend or alter employee working hours in order to meet changing business needs.

Education

(Essential) A relevant degree, in a science, technology, engineering or maths related subject, with a 2:1 or higher.

Experience

(Essential) Working with computer systems, MS office

· (Essential) Experience as an internal auditor

· (Desirable) Has worked in a similar role within the Medical Device/Pharmaceutical industry

· (Desirable) Working knowledge and experience with a Quality Management System, such as deviations, investigations, CAPA, and customer complaints.

· (Desirable) Experience of ISO certified QMS (ISO13485)

Knowledge

(Essential) In depth understanding of approaches to quality for legal manufactures

· (Desirable) Knowledge of quality regulations (such as, ISO 13485, ISO 9001, ISO27001).

Skills & Abilities

- The following skills are essential

· Excellent communication skills

· Accuracy and attention to detail

· experience led approach to problem solving.

· Business proficiency English with excellent written and verbal communication skills.

· An excellent learner and listener, with strong critical thinking, analytic and interpersonal skills.

Other Requirements

. Flexible, with good time management skills and an ability to self-prioritize work.

· Capable of multi-tasking and delivering to agreed schedules.

· Keen to learn and understand complex systems comprised of multiple technologies.