Quality Systems Engineer
Office based - UK (Cambridge) some flexible home working
Competitive salary and benefits package, including a pension scheme and private medical insurance.
Ori are taking critical steps towards reaching commercialisation and essentially developing a Quality Management System capable of leading the business through its ambitious plans.
This individual will be responsible for operating and maintaining the Quality Management System (QMS), writing procedures and processes to support the QMS development. Lead and undertake audits across all areas of the business as well as across the supply chain. Provide training and champion the Quality Management System. Work on any phases or sub-tasks of projects of entire projects of moderate complexity, with results impacting on project completion.
- Participate in the effective implementation of the Quality Management System throughout Ori, including certifications.
- Maintain the Quality Manuals and Quality procedures and ensure contents are appropriate for business.
- Maintain the daily operations of QMS with respect to (not all inclusive), SOP’s, Policies, CAPA’s, training, NCR’s, SCAR’s, Change Controls, feedback, Complaints etc and report metrics to Head of Quality.
- Organise and manage the internal audit system and the corrective and preventive action reporting system.
- Conduct Quality Systems audits and assist in training/guidance to other auditors.
- Providing training on Quality issues, where required.
- Collate quality data for monitoring targets.
- Assist with training of quality awareness.
- Report on Key Performance Indicators (KPIs) in order to adhere to process and prevent occurrence of any non-conformity related to product, process or system.
- Keep up with current and developing manufacturing and engineering trends that concern product quality.
- Undertake quality role in various internal projects, as required.
- Contribute to continuous improvement activities.
- Write reports and present quality metrics at project meetings and to leadership team.
- Participate in the root cause analysis, where required and resolve problems.
- Independently determine approach and assigned tasks.
- Strong knowledge for managing Quality Systems e.g., CAPA’s, NC’s, SCAR’s, CC etc.
- Strong knowledge of running reports on KPI metrics.
- Understanding of engineering drawings and manufacturing processes.
- Ability to work in a diverse and dynamic environment.
- Problem-solving skills.
- Team working skills.
- Ability to work on own initiative.
- Experience of 3-5 years of working within ISO13485 certified Quality System environment.
- Experience of working in Quality Assurance/ Department as a Quality Engineer.
- Previous experience in a medical device start-up environment, is desirable.
- Sig Sigma/Lean Manufacturing skills, are desirable.
- Experience of dealing with customers and suppliers, is desirable.
- Enthusiastic, inquisitive, and passionate with a love of technology and product design.
- Self-motivated, persistent and collaborative, you have a “can-do” attitude and approach.
- A keen eye for detail.
- Equally capable of working independently or as part of a team.
- Confident working with varied teams from diverse backgrounds: biology, manufacturing, quality, commercial, legal, etc.
- An excellent communicator, you are adept at information sharing and contributing towards an open, positive team atmosphere.
- You are excited about the prospect of making a real difference to patient outcomes.
Contract Type: Full time, permanent
Please send an up to date CV, with salary expectations with a short cover note indicating your suitability to email@example.com
No recruitment agencies.