Job Description
Standards and Regulations
Good knowledge of the relevant Standards/Regulations for medical device manufacturers (ISO 13485, ISO 14971, MDD, MDR, 510(k) etc.)
Ensuring compliance of products as per MI PLM and SHPL QMS requirements
Co-ordination with Quality Manager on various SHPL QMS related activities
Conducting/participating in Internal Audits and External Audits,
Coordination and ensuring closure of audit findings within the projects
Process Management
Supporting for maintaining and improving of product and process quality
Lean/Agile Implementation
Skills to Collaborate with all stakeholders to implement lean /agile initiatives across organization
Guide teams with Agile/Lean principles and practices (E.g. Reduce waste, VSM) to deliver value frequently and regularly to the customers
Quantitative Project Management using statistical methods
Desired Qualification and Experience
Qualification : BE / B.Tech/ /MCA
Experience: 5 to 8 years experience in SW Development / Testing / Quality Assurance.
Knowledge and Experience:
Knowledge of Quality and Process Management and related standards (e.g. ISO 13485, ISO 14971, MDD, MDR, IEC 62304 etc)
Possess Internal Auditor/Lead Auditor Certifications from notified bodies
Experience In Facing And Conducting Audits Required.
Experience in healthcare domain is desired.
Experience in implementing Agile/Lean Principles and Practices in projects
Strong written and oral communication skills
Excellent interpersonal skills and ability to work independently on problems.
Have good moderation and presentation skills and ability to interact with various levels of management
Ability to effectively communicate and interact with different stakeholders of the organization
