Quality Manager
Quality Manager
Posted on :
16-03-2025
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1 Vacancy
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Job Description
Quality Manager
Bangalore
Job Purpose
The Quality Manager will be a key member of the QA organization of a growing medical device company developing and manufacturing software as medical devices. The position will manage or support key areas of Quality Management System (QMS) including but not limited to new product introduction change management CAPA complaint handling suppliers and training. The Quality Manager will also interface with peers and external development partners.
Responsibilities
- Serves as the system administrator for the electronic QMS (eQMS) and Learning Management System (LMS). This means youll be responsible for managing these digital platforms that help us maintain high standards in how we operate and how we train teams.
- Manage improve and maintain quality methodologies processes and procedures. Support continuous improvement initiatives and projects to improve processes and upgrade the QMS to meet expanding quality activities for commercialization.
- Establish and maintain effective cross functional team communications to advance quality.
- Develop master plan for thequality initiatives and objectives following directions from leadership to drive improvements across the organization. Improving key aspects of quality systems will be part of your daily tasks. This includes areas like supplier management production and process control document control risk management Corrective and Preventive Actions (CAPA) and handling complaints and ensuring that software development lifecycle processes meet best practices.
- Contribute to QMS management reviews as directed by Management Representative.
- Interface with quality assurance peers in external partner organization to maintain strategic goals
- Manage and support internal and external audits and inspections including those from regulatory bodies like the FDA and MDSAP. Ensure that theoperations and documentation comply with internal Standard Operating Procedures (SOPs) policies good documentation practices and external regulations.
- Partner with R&D Engineering Clinical etc. in the development of new products including establishing standards for these products. Provide input on content and quality of product requirements design and test protocols.
- Develop or approve recommendations to change systems policies and procedures; ensure timely and accurate implementation. Assure systems are in compliance with ISO and FDA quality system regulations. Responsible for understanding tracking and complying with external regulations and standards and updating procedures to conform to latest versions.
- Maintain and update training programs and managing the configuration of controlled documents will be essential and ensuring that new employees are trained according to QMS requirements and that all training materials are current and accessible.
- Manage Learning Management System (LMS) activities including but not limited to: functional training curricula set up/updates employee onboarding training setup/updates.
- Ensure the proper issuance retrieval and archiving of controlled documents through document management system is critical. Oversee the approval distribution modification and retention of documents in accordance with internal policies and regulatory requirements.
- Coordinate and distributes document revisions and review cycles for all documents including delegation to the appropriate groups for review to ensure business continuity.
- Review and ensure good documentation practices (GDP) compliance with respect to QMS and production related records and documentation.
- Support Quality Management in preparing for and conducting site visits from regulatory agencies or other accrediting bodies. This involves ensuring that documentation and practices meet regulatory requirements and that we are prepared to demonstrate compliance during inspections Conducting required periodic review/inspection assessments of QMS documentation (e.g. executed design development production and distribution forms for compliance to US 21CFR11 US 21CFR820 and other requirements as applicable)
- Oversee and handle various short and longterm QArelated projects and support or lead other tasks and responsibilities as assigned.
Required Skills & Experience
To perform this job successfully an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge skill and/or ability required.
5 years experience with FDA and ISO 13485 regulated medical device product development
- Practical knowledge or experience with design controls production and process controls CAPA complaint handling postmarket / vigilance requirements
- Experience with MDSAP ISO 13485 ISOCFR 820 FDA QSR Health Canada TGA and EU MDR.
- Ability to author review and update technical or QMS documents.
- Experience with software validation and software hazards analysis.
- Experience or practical knowledge of IEC 62304 and agile methodologies is preferred.
- Experience with software quality and software as a Medical Device (SaMD) a plus
- Must have 2 years managerial experience in a quality assurance position.
- Attention to detail and meticulous recordkeeping.
- Ability to work both independently and as part of a highly integrated team.
Employment Type
Full Time
Key Skills
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