该职位来源于猎聘 About Us Orka is an innovative VC-backed startup dedicated to revolutionizing the hearing aid market with our groundbreaking products and services. Our mission is to improve lives by developing exceptional hearing aids that cater to individual needs while incorporating cutting-edge technology, to transform people's hearing journey from chaos to simplicity. We have operations in the US and China, and as we continue to expand, we are looking for an exceptional RA&QA expert to join our growing team.

What You'll Do

• Develop and maintain documentation in compliance with FDA, ISO, MDD requirements.
• Actively participate in the Documentation control process.
• Manages operational quality functions responsible for Contract Manufacturer support, Supplier Management, First Article Inspection and Component Approval.
• Act as the QA representative for Supplier Quality management activities. Perform Internal and Supplier Audits.
• Establishes strong operational relationships with key suppliers and internal stakeholders to support new product introduction.
• Support manufacturing sites, including change control process support, with appropriate technological and problem-solving skills and resources to prevent and or minimize adverse situations. Initiate / Approve Validation protocols and reports (IQ, OQ, PQ). Initiate / Approve Engineering Change notices. Review / Approve / Release final product documentation.
• Collate and trend key performance indicator data on a monthly basis. Manages execution of assigned process improvement initiatives, to achieve continuous improvement in all relevant Quality KPIs measuring Contract Manufacturer and Component Supplier performance
• Liase with other functions such as contract manufacturer PMQ and resolve quality and compliance matters. Initiate / Approve Reworks.
• Resolution of quality issues: Initiate / Approve Non-Conformance Reports & Lead Root Cause analysis investigation. Lead Risk Analysis initiatives e.g. FMEA. Initiate / Support implementation of effective Corrective / Preventive Actions.
• Support Notified Bodies inspections (FDA).
• Process Customer Complaints and manage customer replies.
• Actively participate in Management Review & Compliance meetings.
• Performs other related duties, as assigned.
  
  

What You'll Bring

• A degree in manufacturing engineering, quality engineering, life science or related field.
• A minimum of 5-8 years. experience of working as a Quality Engineer within the Medical Device Pharma or equivalent industry.
• Candidate must be highly motivated with excellent communication skills and proven ability to work as part of a team.
• Experience of using Lean Manufacturing Tools and Techniques is an advantage Quality Certification and Lead Auditor Certification, while not mandatory would be an advantage.
• Candidates must be fluent in both English and Mandarin.