Relentless about quality? we have an exciting opportunity for an experienced Quality Assurance Manager to join Johari Digital Healthcare Limited, whose vision is to be the global leader in healthcare technologies and most trusted partners for medical devices development and manufacturing be the part of Johari Digital the place where you can learn without boundaries.
Quality assurance Manager (QA) will aim to ensure that the product is fit for purpose and meets both external and internal requirements, including legal compliance and customer expectations. Quality Assurance Manager will coordinate the activities required to meet quality standards.
Quality manage will also monitor and advise on the performance of the quality management system and produces data and report on performance, measuring against set indicators.
You will liaise with other managers and staff throughout the organization to ensure that the QA system is functioning properly. Where appropriate, advises on changes and their implementation and provides training, tools, and techniques to enable others to achieve quality.
Roles / Responsibilities
1. Setting QA compliance objectives and ensuring that targets are achieved
- Assessing the product specifications of the company and its suppliers, and comparing with customer requirements.
- Agreeing standards and establishing clearly defined quality methods for staff to apply.
- Develop, implement, communicate and maintain a quality plan, to ensure the Company’s Quality Systems and Policies are in compliance with the quality system.
- Manage the test and release scheduling so products are released in a timely manner.
- Defining quality procedures in conjunction with operating staff.
- Setting up and maintaining controls and documentation procedures.
- Manage and maintain the Company’s quality inspection and product release programs for incoming and in-process materials and components, processes and finished goods.
2. Promoting quality achievement and performance improvement throughout the organization
- Collating and analyzing performance data and charts against defined parameters.
- Maintain record and work towards the reduction of rejection n rework.
- Working with purchasing staff to establish quality requirements from external suppliers.
- Support supply chain initiatives around supplier management including quality agreements and supplier audits.
- Identifying relevant quality-related training needs and delivering training.
- Ensuring tests and procedures are properly understood, carried out and evaluated and that product modifications are investigated if necessary.
- Supervising technical staff in carrying out tests and checks.
- Writing technical and management systems reports.
- Bringing together staff of different disciplines and driving the group to plan, formulate and agree on comprehensive quality procedures.
- Persuading reluctant staff to change their way of working to incorporate quality methods.
- Monitoring performance by gathering relevant data and producing statistical reports.
- Maintaining awareness of the business context and company profitability, including budgetary control issues.
3. Ensuring compliance with national and international standards and legislation (Regulatory Requirements)
- Considering the application of environmental and health and safety standards.
- Liaising with customers’ auditors and ensuring the execution of corrective action and compliance with customers’ specifications.
- Establishing standards of service/product for customers or clients.
- Preparing clear explanatory documents such as customers’ charters.
Required Candidate profile
- The ideal candidate is a critical thinker who will proactively improve the quality systems of the company through internal audits, participation in process improvement programs, and interaction with key partners to obtain constructive feedback.
- Experience: At least more than 5 years of experience in QA .Thorough understanding of regulatory requirements for medical device products industry. Experience in preparation, submission of regulatory submissions for countries in scope.
- Skilled in ISO 13485, U.S. Food and Drug Administration (FDA), CE, Health Canada, Post-market surveillance, UDI, Corrective and Preventive Action (CAPA), Change Control, Deviation, AMV, Sterilization process, Process validation, OOS, QMS, etc.
- Establishing a quality management system in accordance with ISO 13485 and 21 CFR 820
- Experience in reviewing, interpreting changed legislation and implementing it successfully in processes and procedures.
- Good understanding and application of knowledge of regulatory guidelines and requirements of the countries.
- Effective planning, organization, and leadership skills.
- Able to engage effectively with regional/global corporate headquarters to get the support and resources necessary to successfully execute the RA strategy and plan.
- Strong analytical & outstanding problem-solving skills.
- Excellent project management skills and the ability to manage multiple priorities concurrently.
JOHARI DIGITAL HEALTHCARE LTD.
Who We Are?
Johari Digital is proud to be one of the first US FDA cleared electronic medical device manufacturing company in India.
Established in 1979, we are proud to have led the market in introducing the first ELECTROTHERAPY based applications for professionals in aesthetic medicine, sports medicine, neurology and physiotherapy. To date we have developed and manufactured seven generations of non-invasive Hi-Tech electronic healthcare devices which includes electrotherapy, ultrasound, RF, laser and bio stimulation. Continuing as the trendsetter, we have developed the latest smart wearable for Relaxation and Stress management based on USFDA cleared technology.
Our devices carry all the relevant international certificates: US FDA Class I, II, III, CE, and more.
With over 25,000 installations and 145 commercialized produced, which are used daily mainly in Hospitals (PMR Depts.), Pain Clinics, Medical Spas, Wellness and Rehabilitation centers worldwide.