Quality Officer

ABOUT THE ROLE

A member of the Operations Compliance team, reporting to the Quality Manager, this is an exciting opportunity to join a growing team and work closely with various functions. As a key role in the Operations Compliance Team, provide business support and guidance in line with Compliance and Eakin Healthcare Strategies.

With the role located at one of our three operations sites, this is an excellent opportunity for an individual to work closely with both site-based functions and colleagues and wider group colleagues in the Group Operations Compliance Team.

KEY ACTIVITIES

• Involved in the creation, improvement and maintenance of regulatory compliant Quality Management System (QMS) documentation (and training thereof) that will include, but not be limited to:
  • QMS reports and analysis of reports for review by the Quality Manager.
  • Quality reports for review at Management Review meetings.
  • Reviewing and actioning feedback from customers.
  • Support creation, revision and maintenance of Operating Procedures, Quality Forms and Work Instructions.
  • Support QMS studies and reports e.g. stability studies.
  • Identification, investigation and documentation of product and process non-conformances document root cause and corrective actions, liaising with relevant departmental representatives to ensure sustained ongoing adherence to quality system requirements.
• Support and execute the timely release of finished medical devices to ensure schedules are maintained and stock available.
• Support and co-ordinate the accurate completion, retention, and review of product release documentation, liaising where necessary with the relevant internal stakeholders and ensuring all product release documentation complies with the appropriate site regulatory certification and standards (ISO13485, MDSAP, GMP, GDP, FDA CFR).
• Inform and collate quality feedback data ensuring that key information is relayed to the Quality Manager.
• Support and perform internal audits under guidance from the QHSE Auditor or Quality Manager.
• Assisting the Quality Manager with the achievement of annual objectives as directed.
• Collate and trend quality metrics and suggest improvement activities as required.
• Support and assist third party audits and inspections across Eakin Healthcare as required.
• Assist with ensuring the QMS reflects practice and is kept up to date in line with requirements.
• In conjunction with other departments, ensure all reported Customer Complaints are acknowledged, investigated, and reported within Target Closure timelines.
• In conjunction with other departments, ensure all stability studies are documented, actioned, and reported.
• Collaborate and own Corrective and Preventative Actions, Customer Complaints, Non- Conformances, and subsequent product dispositions e.g. product rework administration.
• Maintain the Calibration
• Support the change control system by accurate completion of documentation and realising any relevant actions.
• Log and measure QMS and product Key Performance Indicators, demonstrating QMS
• Ensure product quality standards are met by implementing inspection and testing protocols on products within all production, goods in and warehousing
• Ensure inspections are performed in compliance with QMS documentation and that the inspections are being recorded accurately.
• Develop a high level of understanding of the safety and functional aspects of each product
• Report all Quality related issues to the Quality Manager
• Comply with QMS requirements for wearing the correct protective clothing as outlined in the relevant QMS documentation.
• Carry out product segregation and quarantine actions when necessary.
• Ensure testing requirements are met at all stages of the production process and that appropriate documentation is
• Ensure accurate records of any inspection and test activity are completed and forwarded to the Quality Manager for review against specified targets.
• Develop a thorough knowledge of the Operating Procedures, Work Instructions and Quality Forms relevant to the various Production areas and Goods In.
• Assist the Quality department with Quality System/Product development administration tasks as
• Provide accurate data relating to inspection levels for analysis by the Quality Manager.

Other

• To adhere to the company’s Equal Opportunities policy and Dignity at work policy in all activities and to actively promote equality of opportunity wherever possible.
• To be responsible for your own health and safety and that of your colleagues, in accordance with the company’s’ Health and Safety policy.
• To adhere to the company’s Quality policy and Environmental policy.
• To undertake other duties as may be reasonably required.

KEY SKILLS

Essential

• Minimum of 5 GCSE or equivalent, including Math and English and/or a minimum of three years’ experience in a medical device manufacturing. Proven experience in a volume manufacturing regulated environment in a Quality based role, with compliance experience to a quality standard.
• Strong interpersonal and communication skills.
• Able to quickly build effective professional working relationships.
• Meticulous with high levels of attention to detail.
• Strong command of written English.
• Excellent verbal communication skills.
• Excellent organisational and planning skills to deliver efficient QMS based outputs.
• Proactive and able to work unsupervised.
• Ability to work well in a team.
• Competent in the use of Microsoft office

Desirable

• Experience of working in a product/batch release role in the medical device/pharmaceutical industry.
• Experience of working in a regulated manufacturing environment (e.g., ISO13485, ISO14971, MDD, EU MDR, MDSAP).
• Experience of using an electronic quality management system (eQMS).
• Experience in good documentation practices (GDP).
• Experience in a medical device / life sciences environment.
• Experience of using problem solving and root cause analysis tools (8D, FMEA etc.).
• Experience in implementing and ensuring timely completion of appropriate Root Cause analysis and Corrective or Preventative Actions arising from product/process/customer complaint/audit issues.
• Experience in development of training materials and delivery of training presentations.
• Quality auditing certification.
• Methodical with analytical and problem-solving

KEY WORKING RELATIONSHIPS

Internal

• R & D – to ensure that quality and regulatory requirements are met during new product introduction projects
• Production – to liaise with production personnel at all levels to ensure requirements for quality are defined and met. Develop, implement and maintain appropriate quality metrics.

External

• Dealing with suppliers to discuss quality related issues and improvements.
• Dealing with customers and third-party auditors during quality audits

ADDITIONAL INFORMATION

• Occasional travel to other companies within the group and to supplier premises may be required.
• Access to transport

COMPETENCIES

Action Oriented
Taking on new opportunities and tough challenges with a sense of urgency, high energy, and enthusiasm.

Collaborates
Building partnerships and working collaboratively with others to meet shared objectives.

Manages Conflict
Handling conflict situations effectively, with a minimum of noise.

Interpersonal Savvy
Relating openly and comfortably with diverse groups of people. 

Communicates Effectively
Developing and delivering multi-mode communications that convey a clear understanding of the unique needs of different audiences.

Instils Trust
Gaining the confidence and trust of others through honesty, integrity and authenticity.

Nimble Learning
Actively learning through experimentation when tackling new problems, using both successes and failures as learning fodder.

Being Resilient
Rebounding from setbacks and adversity when facing difficult situations.