Location
Bangalore | India
Job description
ABOUT US: ABM Respiratory Care is a medical device company with a product portfolio of respiratory solutions focused on airway clearance and ventilation therapies. Our mission is to advance the healthcare industry by developing intelligent, clinically differentiated, and innovative respiratory care solutions to help people breathe better inside and outside the hospital .
WHAT WE OFFER:
· A place of learning, growth, and advancement opportunities
· Excellent bonus program
· Inclusive workplace culture
· Company insurance coverage
· Flexible hours working
POSITION TITLE: QA/RA Manager
JOB LOCATION: Bangalore, India
DEPARTMENT: QA/RA
REQUIRED EDUCATION: BTech (B.E)/M Tech (M.E) in Bio Medical engineering discipline or equivalent experience in a medical device environment
KEY RESPONSIBILITIES:
Quality and Regulatory:
- Develop, implement, and maintain a quality management system (QMS) to ensure the consistent quality of products or services
- Be responsible for establishing approved documents, maintain and continuously improve Quality System processes required by international, regional, and national regulatory authorities and standards (e.g., 93/42/EEC, ISO13485, FDA QSR, EU MDR 2017/745)
- Conduct internal audits to assess compliance with quality standards and regulatory requirement
- Implement corrective and preventive actions to address non-conformities and continuously improve processes
- Manage the process of obtaining regulatory approvals and certifications for new products or product changes
- Act as liaison between company and third parties including regulatory agencies, Notified Bodies, EU Representatives, etc
- Maintain compliance and timely registration for licensing and products associated with the business. Identify compliance issues that require follow-up and conduct internal investigation of compliance issues with the aim of continuously looking for process improvements and ruling out non-compliance issues
- Drive a culture of continuous improvement in quality and regulatory processes
- Use data and metrics to identify areas for improvement and implement changes accordingly
- Prepare for and participate in external audits by regulatory agencies or certification bodies
- Manage responses to audit findings and implement corrective actions.
- Work with company's cross functional teams, suppliers, and external consultants, to ensure that regulatory and quality requirements are established and implemented as the company progresses
- Provide training to employees on quality standards, regulatory requirements, and the importance of compliance
Product Development and Manufacturing QA RA :
- Provide quality and regulatory affairs input for the product development team and handle all QA & RA responsibilities through product development, design change and post market surveillance process
- As part of core team, work with engineering team to ensure project team follows established Quality and PRD process
- The appropriate execution and documentation of design control activities (e.g., Design Inputs, Design Outputs, Design Verification)
- Plan and support in project milestones
- Provide engineering and manufacturing with the relevant quality and regulatory requirements that are part of Design Inputs for further product development
- Product and Process Validation: The establishment of product & process validation plans
- Provide engineering and manufacturing with the relevant quality and regulatory affairs requirements that are part of product and process validation requirements
- Establish and analyse key performance indicators to evaluate and continuously improve the QMS
- Ensure review and approval of product and quality prior shipped to customers
- Identify and assess potential risks related to quality and regulatory compliance
- Develop and implement strategies to mitigate risks and ensure product safety
SKILLS & RESPONSIBILITIES:
- B.Tech (B.E)/M. Tech (M.E) in Bio Medical Engineering discipline or equivalent experience in a medical device environment (At least 7+ yr's QA RA experience preferred)
- Good knowledge of USFDA regulations, 21CFR820 Quality System, EU MDR (2017/745) and ISO 13485:2016 regulations
- Highly practical, hands-on approach to quality system implementation, writing procedures, doing gap analysis with standards
- Excellent communication skills (including fluency in written and verbal English)
- Strong organisational and team-working skills including commitment and flexibility
- Prior start-up company experience highly desired
- Ability to work under pressure and tight schedules
- Decision making skills: He/she should have the ability to analyze information and evaluate results in order to make the best decision in solving problems
- Excellent attention to detail and working knowledge of appropriate regulation and good manufacturing practices
Job tags
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