Quality Specialist

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 Group Operations Compliance Team strategy, provide business support and guidance in line with the Group Operations 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.
  • Create, review and maintain operating procedures, quality forms and work instructions.
  • 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
  • Risk assessments associated with QMS updates.
• Provide first line supervisory support to Quality Officers, in areas of personal development and objective setting.
• Execute and lead the timely release of finished medical devices to ensure schedules are maintained and stock available.
• Oversee 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, collate and analyse quality feedback data ensuring that key information is relayed to the Quality Manager.
• Perform internal audits to schedule.
• Assisting the Quality Manager with the achievement of annual objectives as required.
• Monitor, trend and analyse quality metrics and suggest improvement activities as required.
• Assist at 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.
• Ensure all reported Customer Complaints are acknowledged, investigated, and reported.
• In conjunction with other departments, ensure all stability studies are documented, actioned, and reported.
• Facilitate meetings to track, support, coordinate and where applicable, complete closure of Corrective and Preventative Actions, Customer Complaints, Non- Conformances and subsequent product dispositions e.g. product rework administration, Concessions.
• Be accountable and ensure compliance of Calibration
• Support the change control system by accurate completion of documentation and realising any relevant actions.

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  

• A level or equivalent and/or, a minimum of five years’ experience in 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

Balances Stakeholders
Anticipating and balancing the needs of multiple stakeholders.

Directs Work
Providing direction, delegating and removing obstacles to get work done.

Plans and Aligns
Planning and prioritizing work to meet commitments aligned with organizational goals.

Ensures Accountability
Holding self and others accountable to meet commitments.

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.

Self-Development
Actively seeking new ways to grow and be challenged using both formal and informal development channels.

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