Quality Specialist

Job Purpose:

To maintain and support the quality management systems within a medical device ISO 13485, manufacturing environment.
Contributing to ensuring all relevant contributing systems are maintained and monitored.
The quality specialist will work with the quality department reporting to the quality manager focusing on the processes and procedures necessary to ensure all manufactured devices meet the internal and international quality standards.

Key Performance Measures:

• Customer Complaints
• Timely CAPA close out management
• Internal Audit to schedule
• Environmental monitoring control
• Documentation control
• Writing and implementing of procedures

Key Responsibilities:

• Contribute to the maintenance of the quality management system and ensure adherence within the various sites.
• Maintain working knowledge of Regulatory and Quality System requirements.
• Support customer & 3rd party audits, including yearly QMS audit.
• Writing and updating documentation for maintenance of the quality management system.
• Lead the CAPA system, complaint management process and documentation control with team support and provide monthly reviews to senior management.
• Facilitate investigations and resolution of related quality issues ensuring structured root cause analysis and robust CAPA plan implementation. Communicate and support resolution and close out activities.
• Part of the internal quality audit team by auditing the quality and manufacturing processes to ensure both internal and external regulations and standards are being adhered to and maintaining the schedule for internal audit.
• Drive continuous improvement of core processes to ensure quality is maintained while efficiency is optimized.
• Train and provide assistance to the other QA teams on quality procedures, protocols, and documentation.
• Train extended staff on quality procedures, protocols, and documentation.
• Develop the standard measurements for processes to be compared against
• Contribute to the creation of Standard Operating Procedures (SOPs) for the manufacturing process with respect to quality considerations.
• Coordinate investigation of quality issues with customers and suppliers
• Assist with the monitoring, measurement and recording of environmental conditions significant to preservation of product and for packaging of product to be sterilised
• Leads Quality related projects and represents quality as and when required on projects across operations

Decision Making:

• Works with minimal supervision, taking personal responsibility for own actions and for the quality and accuracy of the work that is produced
• Uses personal judgement and initiative to develop effective and constructive solutions to challenges and obstacles
• Applies the tools within the relevant quality standards and procedures confidently within their role as specialist

Communication & Contacts:

• Builds strong relationship across the wider team to share good practice, updates and learnings
• Has a strong understanding of the importance of working with a diverse range of stakeholders
• Confident in preparation and presentation activities

People Management:

Gives feedback and support to Prima employees. Excellent written and verbal communication skills.

Financial Responsibility:

• Contribute to budgeting for the quality department overall budget
• Costing and invoicing of services required to aid in carrying out your role

Equipment:

• All employees are responsible for the care and safekeeping of all company equipment as appropriate to their role
• Issues requiring training and/or qualification not undertaken/held by the employee must be escalated to the correct person
• Untrained/unqualified employees are forbidden from undertaking the use or maintenance of equipment

Qualifications & Experience:

• Scientific or engineering degree with experience in the medical device or pharma industry, in a quality related position.
• Certification, such as Quality Engineer, Quality Auditor, Six Sigma, or Quality Improvement Associate, is preferred
• Working knowledge of ISO 13485, 21 CFR 820, ISO 14971, Medical Device Directive 93/42/EEC, Medical Device Regulation 2017/745.
• Project management desirable
• Formulating and execution of corrective action programs
• Superb computer competence, including experience with databases and Microsoft Office
• Knowledge of QA terms, tools, and methodologies

Personal Qualities:

• Analytical skills – Ability to interpret data, spotting trends and planning corrective actions
• Organisational skills – Track testing results, documentation, and recommendations
• Excellent written communication – concise and accurate written documentation is essential. Also required to review internal and external guidance, and potentially write company SOPs
• Interpersonal skills – Able to provide training to staff on quality systems, working closely with manufacturing team members to find and eliminate errors in the processes
• Attention to detail – must be able to audit processes for non-compliance. Provide guidance and solutions for non-conformities. Ability to read and interpret the details of external guidance and industry regulations
• Critical/logical thinking – Ability to identify problems and solutions to ensure efficiency and quality of the manufacturing process

Working Environment and Context:

• This role is office based (with some remote working available)
• The nature of the work requires a willingness to undertake national and international travel and have a flexible approach to working hours
• Working within the manufacturing environment will be required

 

Closing Date: 04 February 2022

 

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