Senior Manager - Quality Assurance - Medical Devices

Senior Quality Assurance Manager - Medical Devices Software Validation

- Emprise HR a leading Executive Search having a strong presence in the Pharmaceutical Sector is looking for Sr. Quality Assurance Manager for one of our leading clients in medical Industry. We have prudently built a reputation of being preferred partners to leading Global organizations as well as Indian SMEs in this field who turn to us for focus, proven expertise, innovative search strategies, and unequaled reach in this specialized business area.

Job description :

SQA - Manager :

- The SQA will be responsible for all aspects of quality control and regulatory requirements software projects. This role will ensure Software projects are conducted in accordance with approved procedures and regulatory standards, and that the product developed satisfies customer needs.

- Working with team members throughout the entire Software Development Life Cycle (SDLC) to ensure compliant implementation of medical device software

- Support Software Validation which includes ensuring that the team follows approved processes for creating Software Requirement Specifications, Software Design Specifications, software architectures, traceability analysis, risk analysis, software code reviews, software verification & validation documentation and maintaining software anomalies (bug lists)

- Review software testing against applicable process requirements

- Review of Software version control, release and software archiving procedures in the project

- Participate in the Riskhazard analysis activities of the Project as an independent reviewer.

- Ensure the project is in regulatory compliance with applicable standards

- Identify and implement improvements that will ensure customer continues to produce compliant products that satisfy customer, regulatory and business requirements, more effectively.

- Collaborate with customer stakeholders to ensure software follows SDLC and meets compliance requirements.

Accountability 1 : 

- Ensure the Release of High-Quality Products

- Ensure all quality processes are capably executed and are in compliance.

- Execute quality documentation review activities - protocols, reports, non-conformances.

- Ensure that non-conformances and CAPAs are resolved quickly and appropriately and supporting documentation is thorough and audit ready.

- Escalate where product is not of sufficient quality to be released or processes are not being appropriately applied which may result in risks to product quality

Accountability 2 : 

- Assist in the implementation of Continuous Improvement to Quality Processes

- Plan, conduct and complete reports for Internal Audits.

- Work with the Software group to resolve findings identified during internal audits

- Assist in the delivery of training for the Software Group to ensure the group are competent in the execution of all quality operational processes and to ensure the Group is audit-ready at any time.

- Collect process monitoring data and acceptance activity data to identify areas for preventive actions and continuous improvement.

Accountability 3 : Maintain Regulatory Compliance of all Processes

- Continually improve and implement new processes to maintain compliance with applicable regulations, standards and directives and customer's internal requirements.

Required Candidate profile :

Key Incumbent requirements :

Minimum :

- Engineering or computer science degree (electrical computer engineering or software discipline preferred)

- Experience as a quality engineer in medical software product development projects and medical device software validation processes (4+ years)

- Experience in projects from inception through to launch and continued support to the software life cycle.

- Excellent communication and influencing skills

- Excellent organizational and interpersonal skills : including the ability to competently liaise and provide feedback to internal and external customers regarding project issues.

- Being able to work independently as well as within a cross-functional team to influence projects in regards to software validation.

- Methodical approach to problem-solving

- Passion for consistency, standards, accurate and complete documentation.

- Experience in software development methodologies such as Agile and Scrum

- Experience with 62304 and 14971.

Ideal :

- Knowledge of ISO9001ISO13485 (FDA QSR and cGMP knowledge an advantage)

- Knowledge of 21 CFR Part 11 compliance

- Highly developed audit capability

- High proficiency in writing procedural and technical documents.

- Knowledge in the application of risk-based methodologies.

- Experience in a regulated environment an advantage

- Statistical software skills an advantage

Education :

UG : BCA in Computers, Diploma in Computers, B.Tech/B.E. in Electrical, Computers

PG : MS/M.Sc(Science) in Computers, MCA in Computers, M.Tech in Computers, PG Diploma in Computers

Doctorate : Doctorate Not Required, Any Doctorate in Any Specialization

Interested and suitable candidates apply with updated resume.