Responsibilities- Instruct, coach and facilitate project team’s w.r.t Innovation Site -Quality Management System (Procedures/ Policies/ Guidelines/ tools/ training, etc.). - Instruct, coach and facilitate project teams on relevant product standards (IEC60335/IEC60601/21 CFR820/ISO13485, etc.) - Drives and supports quality & regulatory compliance to assure products & services comply with the Quality Management System / Business Management System requirements - Create quality function deliverables as per Innovation Site –Quality Management System in projects, in Life Cycle Management and in Post Market Surveillance. - Review Requirements Management process and outcome. - Reviews Product Verification and Validation. - Ensure Risk Management quality (quality of UFMEA, DFMEA, PFMEA/HB-SRA, etc.). - Ensure compliance to quality system requirements, regulations and standards in designated area of responsibility. - Ensures timely execution and required communications and escalation.
Requirements- Bachelor degree with 5+ years of related experience or a Master degree with 3+ years of related experience. - Applied knowledge of appropriate global medical device or consumer product regulations, requirements, and standards such as 21 CFR Parts 803, 806, and 820, ISO13485, and ISO9001. - Preferably experience in a medical device industry. - Proven ability to successfully incorporate and manage stakeholder needs throughout a project - Communicate globally, across teams and programs, from senior executives to administrative support personnel. Experience leading remote teams. - Both detail oriented and able to see big picture
Are you interested and do want to apply for this role, please fill out your application via the apply button below and contact Robin Hiariej.