Responsibilities- Ensure compliance to all applicable regulations and internal procedures by proactively interpreting regulatory and quality requirements and determining way of working - Support New Product Introduction by providing QA technical expertise, assessments, and strategies for problem resolution & prevention - Serve as Subject Matter Expert for quality system and design control requirements within project teams - Participate in risk assessments and take appropriate action during QA oversight activities to ensure adequate controls in relation to level of product quality, safety and business risks. - Review and approve Product Design Quality Records (DHF documents such as specifications, risk assessment reports, validation & verification test protocols/results/reports, etc.) - Review and approve Corrective Actions and Preventive Actions (CAPA) in order to meet compliance requirements. - Review and approve product change controls for quality and regulatory compliance impact and determine requirements for implementation - Accountable for interactions to enhance QA reputation within the company and to promote teamwork & understanding of quality requirements
Requirements- MS in related field plus 2+ years of QA experience, BS/BA in technical field with plus 4+ years’ experience. - Demonstrated knowledge & expertise on subjects mentioned below but not limited to: - ISO Standards (i.e., 13485, 14971, 14001) - US, EU & International Medical Device Regulations (i.e., 21 CFR 820, MDD) - Medical Device Design Control Requirements - Lead / Internal Auditor Training - Excellent Communication - Excellent QA/Regulatory Writing Skills in English - Proficient in Microsoft and other organizational tools - Ability to effectively interact with various business departments & resolve QA compliance/technical issues/conflicts
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.