ES_QA (Sr.) Engineer
SHL’s Engineering Solution department is seeking a ES_QA Engineer to support internal process development.
1. Responsible to follow all applicable SOPs and Guidelines at all the times and ensure the content, context, organization and overall quality of all regulatory documentation is adequate and sufficient to meet all regulatory requirements, commitments and agreements;
2. Responsible in supporting quality principle, decisions and practices;
3. Provide support to implement necessary requirements to comply with the Medical Device Regulation (MDR);
4. This engineer is capable of basic and entry level capability and requires some assistance to execute job tasks below;
4.1 Author procedures, Guidelines or other documents.
4.2 Review completeness of the Technical File.
4.3 Participate in Risk Analysis and FMEA
4.4 Issue Corrective and Preventive Actions (CAPA), leads cross functional team to perform root cause analysis and identify corrective actions.
4.5 Verify the effectiveness of corrective/preventive actions.
4.6 Assist QA Manager by participating in all activities related to the project, which include but not limited to change control and process improvement.
4.7 Provide training to other function members in QA systems.
4.8 Participate in internal audits, and when required external audits.
4.9 Interfaces with other functions’ members and customers to resolve issues.
4.10 Review Design History Files; Participate in Design Review Meeting, and review Design Milestones.
5. Carry out other duties as assigned.
Qualifications for ES_QA Engineer:
1. Engineering Degree in biomedical sciences, medical engineering or equivalent.
2. 3+ years professional experiences in the medical device technology industry, preferably in a quality assurance and/or regulatory affairs function.
3. Knowledge of regulations for medical devices in Europe (MDD) and US (FDA).
4. Strong understanding of overall Quality Management System Requirements acc. to ISO 13485:2016 and preferable 21 CFR 820, with focus on Design Controls, Change Controls, Risk Management, CAPA.
5. Familiarity with medical software would be advantageous.
6. Strong English written and verbal communication skills.
7. Problem solving discipline.
8. Intercultural and team competence.
· Competitive compensation package.
· Modern & variety of culture working environment with state-of-the-art facilities and technologies.
· Challenging assignments in a fast growing and innovative industry.
· Position in a dynamic, international team of highly skilled professionals.
· Various opportunities for personal and professional development within a global organisation.
Apply for this Job
For further information on this position or SHL Group, please contact: RecruitTW@shl-group.com, HR Department