We are seeking an experienced QA Manager to join our QA team. In this role, you will develop and execute quality design
(design control) and quality assurance strategies for new product development and sustaining business activities.
(design control) and quality assurance strategies for new product development and sustaining business activities.
Location: Sharon area
Reports to: VP RA/QA
Responsibilities:
• Lead all R&D projects from the design QA side through the design phases.
• Ensure compliance with DHR and DMR requirements.
• Develop and manage risk mitigation strategies for the project together with R&D.
• Support regulatory submissions.
• Plan, establish, and maintain the effectiveness of company quality to meet regulatory expectations.
• Ensure the company’s product quality and reliability to meet or exceed customer expectations.
• Ensure Quality Compliance with regulatory agencies and all applicable standards worldwide.
• Provide effective leadership support, training, and guidance to all company personnel in support of the quality system.
• Lead MRB, CAPA, and ECO committees.
• Approval, audit, and control subcontractor performance.
• Establish and control the traceability system of company products (DMR).
• Approve the release of finished products.
Job Requirements:
• B.A. or B.S. degree in a technical discipline, such as Engineering or Science.
• At least 5+ years of experience in the medical device industry.
• Multidisciplinary experience in medical devices (mechanics, hardware, software).
• Strong knowledge of design control regulations and standards (e.g., FDA, ISO 13485).
• Experienced with IEC 60601 and IEC 62304.
• Demonstrated expertise in leading design control activities, including risk management, verification/validation, and documentation.
• Excellent understanding of quality management systems and their application in the design process.
• Experience with internal and external audits related to design control and quality assurance.
• Strong analytical and problem-solving skills, with keen attention to detail.
• Excellent communication and interpersonal skills, with the ability to collaborate effectively across functions.
• Proficient use of standard MS Office applications.
• Fluent in English (oral and written).