3 Medical Devices jobs in Bahrain
Senior Quality Assurance Engineer - Medical Devices
244 Seef, Capital
BHD85000 Annually
WhatJobs
Posted 17 days ago
Job Viewed
Job Description
Our client, a leader in the development of innovative medical devices, is seeking a highly skilled and meticulous Senior Quality Assurance Engineer to join their globally distributed team. This is a fully remote position, requiring a proactive approach to ensuring the highest standards of quality and compliance. The ideal candidate will have extensive experience in quality management systems (QMS), regulatory affairs, and product lifecycle management within the medical device industry. You will be responsible for developing, implementing, and maintaining robust quality assurance processes, conducting internal audits, and supporting external regulatory inspections. Your expertise will be crucial in ensuring that all products meet rigorous safety, efficacy, and regulatory requirements. You will collaborate with cross-functional teams, including R&D, manufacturing, and regulatory affairs, to proactively identify and mitigate quality risks. This role demands a strong understanding of international quality standards such as ISO 13485 and FDA regulations. Join a team dedicated to improving patient outcomes through cutting-edge medical technology, all while enjoying the flexibility of a remote work environment.
Key Responsibilities:
Qualifications:
Key Responsibilities:
- Develop, implement, and maintain the company's Quality Management System (QMS) in compliance with relevant regulations (e.g., ISO 13485, FDA 21 CFR Part 820).
- Lead and participate in internal and external audits, ensuring compliance and identifying areas for improvement.
- Review and approve design history files (DHFs), manufacturing process documentation, and validation/verification protocols.
- Investigate non-conformances, customer complaints, and adverse events, implementing corrective and preventive actions (CAPA).
- Support regulatory submissions by providing necessary quality documentation and data.
- Collaborate with R&D and engineering teams to ensure quality is integrated throughout the product development lifecycle.
- Train personnel on quality procedures and regulatory requirements.
- Monitor quality metrics and KPIs, providing reports to senior management.
- Stay updated on evolving regulatory requirements and industry best practices.
Qualifications:
- Bachelor's degree in Engineering, Science, or a related technical field.
- Minimum of 5 years of experience in Quality Assurance or Quality Engineering within the medical device industry.
- In-depth knowledge of ISO 13485, FDA regulations (e.g., 21 CFR Part 820), and other relevant international standards.
- Proven experience with QMS implementation and maintenance.
- Strong understanding of risk management principles (e.g., ISO 14971).
- Experience with CAPA systems, non-conformance investigations, and complaint handling.
- Excellent analytical, problem-solving, and decision-making skills.
- Strong written and verbal communication skills, with the ability to document technical information clearly and concisely.
- Ability to work independently and manage multiple priorities in a remote setting.
- Relevant certifications (e.g., ASQ Certified Quality Engineer) are a plus.
This advertiser has chosen not to accept applicants from your region.
0
Remote Senior Quality Assurance Engineer - Medical Devices
223 Busaiteen, Muharraq
BHD95000 Annually
WhatJobs
Posted 1 day ago
Job Viewed
Job Description
Our client, a leading innovator in the medical device industry, is seeking a highly skilled and detail-oriented Senior Quality Assurance Engineer to join their fully remote team. In this critical role, you will be responsible for ensuring the highest standards of quality and compliance for our cutting-edge medical devices. You will design, develop, and implement comprehensive quality assurance strategies, protocols, and test plans throughout the product lifecycle. This is an exceptional opportunity to contribute to the development of life-saving technologies from the convenience of your home office.
Responsibilities:
Responsibilities:
- Develop and execute detailed test plans, test cases, and test scripts for software and hardware components of medical devices.
- Perform rigorous testing, including functional, regression, performance, and usability testing.
- Identify, document, and track software defects and hardware anomalies using bug tracking systems.
- Collaborate with cross-functional teams, including R&D, engineering, and regulatory affairs, to define quality requirements and resolve issues.
- Ensure all product development activities comply with relevant regulatory standards (e.g., FDA, ISO 13485).
- Participate in design reviews and risk management activities.
- Develop and implement automated testing strategies where applicable.
- Analyze test results and provide comprehensive reports to management and project teams.
- Contribute to the continuous improvement of QA processes and methodologies.
- Maintain up-to-date knowledge of industry best practices and regulatory requirements.
- Validate and verify that products meet customer and regulatory requirements.
- Lead or mentor junior QA engineers as needed.
- Bachelor's degree in Engineering (Biomedical, Electrical, Computer), Computer Science, or a related technical field.
- Minimum of 5 years of experience in Quality Assurance, specifically within the medical device or pharmaceutical industry.
- In-depth knowledge of regulatory requirements such as FDA 21 CFR Part 820, ISO 13485, and IEC 62304.
- Strong experience with various testing methodologies and tools (e.g., JIRA, Confluence, TestRail).
- Proficiency in scripting languages for automation (e.g., Python, Selenium) is a plus.
- Excellent analytical and problem-solving skills.
- Superior attention to detail and a commitment to quality.
- Effective communication and interpersonal skills for cross-functional collaboration.
- Ability to work autonomously and manage time effectively in a remote setting.
- Experience with risk management processes (e.g., FMEA) is highly desirable.
- Certified Quality Engineer (CQE) or equivalent is an advantage.
This advertiser has chosen not to accept applicants from your region.
1
Senior Medical Device Sales Representative
20122 Ghuraifa, Capital
BHD70000 annum (plus
WhatJobs
Posted 11 days ago
Job Viewed
Job Description
Our client, a premier provider of innovative medical devices, is seeking a highly motivated and accomplished Senior Medical Device Sales Representative to join their dynamic sales force. This client-facing role is critical to expanding market share and building strong relationships with healthcare professionals and institutions in the Jidhafs, Capital, BH region. The ideal candidate will possess a proven track record in medical device sales, a deep understanding of the healthcare market, and exceptional selling and negotiation skills.
Key Responsibilities:
Required Qualifications:
Key Responsibilities:
- Develop and execute strategic sales plans to achieve and exceed assigned sales quotas for a portfolio of advanced medical devices.
- Identify and pursue new business opportunities within hospitals, clinics, and other healthcare facilities.
- Build and maintain strong, long-lasting relationships with physicians, surgeons, hospital administrators, procurement managers, and other key stakeholders.
- Educate potential customers on the features, benefits, and clinical applications of medical devices.
- Conduct product demonstrations and provide technical support during procedures as needed.
- Negotiate contract terms and pricing to close sales effectively.
- Stay informed about market trends, competitor activities, and advancements in medical technology.
- Manage sales activities using a CRM system, including pipeline management, forecasting, and reporting.
- Attend industry conferences, trade shows, and professional development events.
- Collaborate with marketing and product development teams to provide market feedback and insights.
- Ensure compliance with all company policies and regulatory requirements related to medical device sales.
- Provide exceptional post-sales support to ensure customer satisfaction and retention.
Required Qualifications:
- Bachelor's degree in Business Administration, Healthcare Management, or a related scientific field.
- Minimum of 6 years of successful sales experience in the medical device industry.
- Proven ability to meet and exceed sales targets consistently.
- Deep understanding of the healthcare landscape, including hospital procurement processes and clinical workflows.
- Excellent communication, presentation, interpersonal, and negotiation skills.
- Strong business acumen and ability to understand complex clinical needs.
- Proficiency in CRM software (e.g., Salesforce) and Microsoft Office Suite.
- Ability to travel extensively within the assigned territory.
- A valid driver's license and clean driving record.
This advertiser has chosen not to accept applicants from your region.
Be The First To Know
About the latest Medical devices Jobs in Bahrain !
2