We are looking for a Quality Assurance Specialist who can join immediately to support our quality management system development and implementation, ensuring product development in compliance with ISO 13485 and US Quality System Regulation (QSR). This role will be responsible for daily tasks involving maintaining and our quality processes including but not limited to documentation control, training program, tracking quality performance matrix, and gap analysis.
Responsibilities:
- Quality System Compliance: Ensure adherence to ISO 13485 standards, US QSR and internal SOPs throughout the product development and manufacturing processes.
- Document Control and Change Management: Manage and maintain the document control system to ensure accuracy and accessibility of quality documents. Assist in the development and implementation of quality management policies, procedures, and documentation through change control process.
- Risk Management: Participate in risk assessments and support risk management activities to identify and mitigate potential quality issues.
- Regulatory Compliance: Stay updated on relevant regulatory requirements and standards applicable to medical devices and ensure compliance.
- Quality Audits: Participate in internal and external audits, providing support for corrective and preventive actions (CAPA).
- Supplier Quality: Assist in monitoring supplier and part performance to ensure the quality of components and materials used in the manufacturing process.
- Quality Training: Assist in providing training and guidance to employees on quality assurance practices.
- Non-Conformance Management: Assist in investigating and addressing non-conformance issues, facilitating root cause analysis and corrective actions.
- Continuous Improvement: Contribute to ongoing process improvement initiatives to enhance product quality and efficiency.
Qualifications:
- Diploma or bachelor’s degree with 1-2 years of work experience in a quality assurance role, preferably in the medical device industry.
- Fair theoretical and practical knowledge in ISO 13485 and US QSR.
- Excellent problem-solving and analytical skills.
- Effective communication and interpersonal skills.
- Detail-oriented and able to work independently and in a team.
