QA&RA

Quality Engineer

What will you do?:

• Provide Quality Engineering support to various teams in product realization cycle.
• Provide quality and compliance guidance for process owners responsible for design, development and production of medical devices
• Assist with defining and documenting deliverables in DHF / DHR files in accordance with internal procedures / work instructions and in compliance with applicable quality and regulatory requirements
• Develop and Implement processes for product execution and Product/Process Verification and Validation policies and procedures
• Provide guidance and decisions on Design, Development and Manufacturing activities in compliance with internal procedure and regulatory requirements
• Take active role in risk management activities (DFMEA/PFMEA).
• Write and review product and process verification and validation protocols and reports
• Overall responsibility for DHF and DHR contents assuring full traceability
• Handling non-conformities detected in production and participate in MRB committee
• Review DMR and manufacturing documents, work instructions and procedures, engineering/design change reports (ECOs) and provide inputs related to QA/QC.
• Identify opportunities to proactively assure compliance to international quality regulations e.g., ISO 62304 ISO 13485, ISO14971, US 21 CFR 820 etc.
• Define and implement process control & process monitoring methods for continuous improvement

What do you need to bring with you?:

• Bachelor’s degree in engineering/Scientific field
• 3+ years of experience in Quality Assurance at Medical Device companies (active implants companies – an advantage)
• Familiarity with international quality regulations –ISO 13485, ISO 14971, US 21 CFR 820 etc.
• Ability to partner with R&D / Manufacturing departments and collaborate with various departments within the organization
• Experience in implementing and guide quality standards in day-to-day activity
• Experience in writing and reviewing manufacturing procedures/ work instructions/ forms related to manufacturing processes.
• Experience in writing and reviewing engineering/design changes (ECO).
• Experience in product and process validation, test method validation, statistics, risk management tools
• Experience handling non-conformities (NCR/MRB) in production.
• An ability to successfully communicate and educate QMS regulations, policies, and strategies to employees at all levels of the organization
• Languages: English – excellent level