One of the world's leading pharmaceutical firms is looking to recruit a Quality Compliance Engineer to join their team in Cambridge. They offer a very attractive salary with full benefits package of 10% bonus, 25 days holiday, health and dental insurance, critical illness cover, Pension and share save.
Reporting to the Compliance Team Leader the successful engineer will join the existing Quality team working on a wide portfolio of drug delivery devices with the potential to grow in the role and influence the route to conformity at global level.
Responsibilities of the Engineer:
- To work with co-development teams and external vendors to implement the device design control and risk management strategies for the development of drug delivery devices that meet the needs of both the business and the patient.
- To assist in the generation of Design History File and regulatory submission components.
- Assuring compliance with all relevant design control policies and procedures by working closely with regulatory and quality assurance functions.
- Liaising with colleagues on all aspects of combination product and medical device development and manufacturing.
Requirements of the Engineer:
- Working in accordance with relevant standards and regulations, specifically ISO 13485, ISO 14971, 21 CFR 820, EN 60601, EN 62304, EU Medical Devices Directive and EU Medical Devices Regulation.
- Quality Compliance Background is essential
- Developing drug delivery devices as a team member or significant contributor.
- Developing documentation used as components of Design History Files, Risk Management Files and appropriate Regulatory submissions.
- Collaborative team working both internally and externally with multi-national and multi-disciplinary teams
- Proven problem solving capability
In return the Quality Compliance Engineer will receive a very attractive salary and benefits package
- £40k to £45k
- 25 days holiday (plus bank holidays)
- Buy/Sell up to 5 days holiday
- Flexible Working
- Annual Pay increases
- Bonuses against KPI's (10%)
- Regular one on one appraisals
- Health Care plan
- Contributory Pension Scheme
- Share Saver Scheme
- Free onsite parking
- Ongoing development and training
Last but not least - the opportunity to work for one of the largest pharmaceutical companies in the world
We aim to respond to suitable candidates within 5 working days. If you have not heard from us within this time, please feel free to contact us to receive feedback on your application and discuss your requirements.
Professional Technical is acting as an Employment Agency in relation to this vacancy.