ABOUT THE ROLE
Reporting to the Eakin R&D (ERD) Regulatory Affairs Manager this is an exciting opportunity to play an important role in a growing R&D team. Expansion and diversification of our product portfolio necessitates a dedicated Quality Engineer to support the team in developing our Quality Management System. Working closely with QA/RA functions across the Healthcare Group you will help achieve ISO3485 certification for Eakin R&D and be part of a small team to ensure compliance with implemented procedures. You will also be involved in developing standardized quality related practices across the Eakin Healthcare Group and further strengthening the quality culture.
- Identify and map key ERD processes.
- Identify requirements related to ISO13485 which are relevant for ERD activities.
- Develop documentation and procedures to reflect these key processes and mandatory requirements and ensure they are implemented.
- Provide suitable instruction and training to ERD personnel.
- Ensure compliance with QMS requirements via auditing, CAPA and regular reviews.
- Ensure that suitable processes and controls are in place for ERD documents and records.
- Support ERD colleagues and other departments in the successful completion of project activities relating to Quality, including process and software validation, product identification and traceability and product risk management activities.
- Reviewing and improving ERD processes and systems, implementing change where appropriate and ensuring compliance with the Quality Management System.
- Scheduling, completing and documenting internal quality audits.
- Perform measurement, analysis, trending and reporting of Quality data
- 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
- A degree / HND or equivalent qualification in an engineering, scientific or related discipline
- Proven experience in a volume manufacturing environment as a Quality Engineer or similar.
- Experience of process mapping and procedure development
- Good knowledge of ISO13485:2016
- Strong interpersonal and communication skills
- Ability to work in a multi-functional, multi-disciplinary team and to build effective professional working relationships
- Ability to provide education to support on-going learning at all levels throughout ERD
- Methodical thinker, capable of making rational judgements from available information and meeting targets in agreed timescales.
- Ability to work on own initiative
- Prepared to take a hands-on approach to all quality system activities and to take on ‘ad-hoc’ projects as the business requires.
- Experience in a medical device / life sciences environment
- Knowledge of standards and regulatory requirements associated with medical devices e.g. ISO14971, EU MDR, FDA QSR, ISO 10993
- Experience in development of training materials and delivery of training presentations
- Quality auditing certification
KEY WORKING RELATIONSHIPS
- Working within the R&D team to support QMS activities and provide advice and support to peers
- Collaborating with Quality functions across Eakin Healthcare Group to share knowledge of best practice and collaborate on group-wide Quality initiatives
- Various personnel within Eakin Healthcare Group (including but not limited to Operations, Finance).
- ERD suppliers and sub-contractors
- Ability/willingness to travel to other Eakin Healthcare Group sites if required
Quality Orientation – Is precise, pays attention to details, checks things and ties up ‘loose ends’. Has a strong conscience about getting things right and seeks to ensure that decisions and solutions do not involve undue risk, adheres to policy and standards.
Problem solving – Generates and promotes solutions. Sees clearly which is the best way forward. Able to make decisions and commitments within appropriate time frame.
Resilience – Can work under pressure, remains calm, thinks clearly, and manages emotion under pressure. Addresses issues without being aggressive or controlling and can easily bounce back from setbacks. Is open to feedback and does not dwell on past events.
Team Working – Enjoys participating in group activities and likes to work in proximity with other people. Is ready to collaborate with and support others and is willing to co-operate and compromise for the overall good.
Supporting Others – Enjoys supporting other people and is prone to getting involved and trying to help them when they have problems. Is comfortable to contribute to joint endeavours and enjoys teamwork. Is willing to let other people depend on them.
Analytical – Enjoys analysing qualitative data but also considers quantitative and seeks to identify and explore they key elements in information before making commitments. Tends to like to use facts and figures when planning and reporting and is concerned about accuracy and detail
Information Gathering – Enjoys dealing with and refers to factual data. Likes to be well informed and drills down into details. Prefers to access wide range of information and opinion before making decisions and when solving problems.
Oral Communication – Talks readily and confidently to people, expressing themselves with obvious ease. Speak out and makes themselves heard, often playing a leading and influential role in debate and discussion.