Summary of Position:
Fulfil the company’s quality assurance, design assurance & regulatory affairs responsibilities as part of the Quality team.
- Lead key elements of the Design Review process in compliance to internal procedures including EU and FDA requirements. In-depth knowledge of the design control processes required for a Class III medical device.
- Maintain the Design History files, including managing the filing, storage and retrieval of Design Quality Records.
- Work with research and development to establish design specifications and product requirements.
- Ensure all product quality standards and specifications are defined and achieved in line with company and Regulatory requirements including MDD 93/42 EEC, MDR and FDA requirements.
- Lead key elements of the risk management process and preparation of risk management files including Hazard Analysis documents, Use FMEA and Design FMEA.
- In conjunction with the R&D/Operations teams identify product testing required and write design verification and validation plans, protocols and reports including specifically advising on sample sizing; including but not limited to Ethylene Oxide sterilization, Biocompatibility, Aging, Packaging and Transportation testing.
- Liaise with external vendors for product testing.
- Preparation of Standard Checklists for all the applicable harmonized standards.
- Generation and/or review of quality and technical documentation / change requests to support design activities.
- Routinely provides design assurance guidance and direction to engineers and/or technicians.
- Assist Regulatory with the compilation of design dossiers, technical files, essential requirements, and regulatory submissions documentation as required.
- Support various QA/RA activities including quality management, system reviews, internal & vendor audits, etc.
- Supports regulatory compliance / submission process.
- Drives changes in procedures and standards to facilitate work efficiency, to increase quality and to prepare for ISO13485 / CE Registration.
Skills, Qualifications & Experience:
- Ideally will possess Degree / Post-Grad in engineering, biomedical or science degree.
- 5+ years’ experience in a medical device manufacturing environment with direct experience in a design assurance role.
- Working knowledge of the Medical Device Directive (93/42/EEC)/Medical Device Regulation 2017/745 and FDA requirements including Quality System Regulation (21 CFR 820), applicable harmonised standards and the ability to apply them in practice.
- Previous experience in Ethylene Oxide sterilization, biocompatibility, aging, packaging and & transportation testing is an advantage.
- Knowledge and demonstrated practice of risk management methodologies as per EN ISO14971.
- Experience with involvement in Regulatory submissions would be an advantage.
- Excellent interpersonal and communication skills.
- Strong project management skills and attention to detail combined with proven consistent execution within quality, time and cost targets.
- Proven ability to work well as part of a team and on own initiative.
- Experience / training in problem solving and clinical environment considered a plus.
- Experience in mentoring/guiding team members.
The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified.