Quality Assurance Engineer - Design Quality

440y Varian Medical Systems International (India) Private Limited; India; On-site; INR 1,200,000 - 1,800,000; Full time

Job summary

Siemens Healthineers in Pune seeks a QA Engineer-Design Quality to ensure robust medical device designs and regulatory compliance across projects. You will participate in design reviews, assist audits, and help transfer new products to manufacturing with a focus on Quality System alignment.

Candidates should have 4-6 years in medical device software lifecycle activities, a relevant degree, and certifications in quality assurance. Relocation to Pune may be required.

Qualifications

• Bachelor’s degree in computer science, Engineering or related technical field.
• 4-6 years’ experience in medical device software lifecycle activities.
• Professional certification (ISO 13485, etc.) preferred.

Responsibilities

• Review designs and documentation to ensure compliance with Quality System procedures.
• Support internal/external audits and regulatory submissions as needed.
• Review ECNs for compliance with QSR and relevant standards.
• Provide guidance on Design Verification/Validation protocols and testing.

Skills

Quality Assurance

Regulatory knowledge

SDLC knowledge

Communication skills

Education

Bachelor’s degree in computer science or engineering

Master’s degree preferred

Job description

Join us in pioneering breakthroughs in healthcare. For everyone. Everywhere. Sustainably. Our inspiring and caring environment forms a global community that celebrates diversity and individuality. We encourage you to step beyond your comfort zone, offering resources and flexibility to foster your professional and personal growth, all while valuing your unique contributions.

QA Engineer-Design Quality

QA Engineer-Design Quality typically serves as the quality representative on the cross‑functional project team, works closely with the project team leader. Provides quality assurance and regulatory requirement support and typically works as a member of one or more new product development and/or sustaining engineering projects. Responsible for minimizing risk to the organization associated with product design and realization efforts and assists in ensuring robust medical device product designs under governing international standards and regulatory requirements. Major on‑going responsibilities for this role, but not limited to: Is a member of Pune engineering team and has the responsibility and authority for ensuring Quality System requirements are established and maintained in accordance with applicable quality procedures of Varian Product Life Cycle (PLC) Participate in reviews of designs and design documentation to ensure that all domestic, international engineering practices, Quality System documentation, laws and regulations are being met consistently. Support Quality group during internal/external audits with respect to internal Quality System documentation and all appropriate regulations. Review ECN’s to ensure compliance to Quality System, QSR and International standards and requirements for Product Life Cycle (PLC) and sustaining activities. Ensure that product development projects and changes to existing products are conducted in compliance with all appropriate regulations and standards. Work with teams to ensure successful transfer of new products to manufacturing. Review production processes for quality of Process Validation. Provide input to the creation of Design Verification and Validation protocols and test reports. Provide guidance and direction for sample size and statistical analysis for testing. Provide guidance and/or training to project teams on procedures, Design Verification and Validation, statistical methods and Design Controls. Review Design History Files for conformance to applicable requirements. Supports Regulatory Affairs regarding regulatory submissions e.g. 510(k) submissions containing medical device software. Understand and be able to review software development lifecycle records for compliance with good documentation practices. Maintain a complete awareness of the cost of quality and promote activities to monitor and reduce quality costs. Provide external supplier support as required. May be responsible for specific SME (Subject Matter Expert) support, general improvement projects and support of CAPAs.

Characteristics

Ability to manage multiple projects simultaneously without supervision. Provide authoritative guidance to all appropriate regulations, safety standards and internal Quality System processes. Ability to monitor and analyse process and product data statistically and identify improvement opportunity. Ability to write / review software test scripts manual / automated. Able to work with project teams effectively. Gains buy‑in on new ideas and able to give feedback without offending. Must be able to manage and meet personal commitments. Not only provides input but also provides potential solutions. Excellent communication, problem solving and interpersonal skills (teams). Effective skills in analytical thinking and problem solving. Team player.

Qualifications

• Bachelor’s degree in computer science, Engineering or related technical field required.
• Master’s degree or equivalent preferred.
• 4-6 years’ experience of working on either of medical device software lifecycle phase like design and development, testing, auditing, CAPA or relevant regulatory activities.
• Professional certification (i.e. Certified Internal/Lead Auditor for ISO 13485, SQA-Software Quality Assurance) is preferred.
• Experience of working with healthcare provider that follows ISO 13485, ISO 14971, IEC 62304, FDA QMSR/QSR 21 CFR 820, EU MDR 2017/745, MDSAP, QSIT or similar medical device regulations.
• Experience of healthcare software (SaMD or EMR, EHR) related customer requirement gathering, solution development, verification and validation testing, customer acceptance, complaint handing is preferred.
• Experience of working in regulated industry of medical device is added advantage.
• Working knowledge of software development and/or electrical/mechanical engineering.
• Requires excellent written and verbal communication skills.
• Ability to relocate to work location to work with geographically diverse and international teams.

Who we are

We are a team of more than 72,000 highly dedicated Healthineers in more than 70 countries. As a leader in medical technology, we constantly push the boundaries to create better outcomes and experiences for patients, no matter where they live or what health issues they are facing. Our portfolio is crucial for clinical decision‑making and treatment pathways.

How we work

When you join Siemens Healthineers, you become one in a global team of scientists, clinicians, developers, researchers, professionals, and skilled specialists, who believe in each individual’s potential to contribute with diverse ideas. We are from different backgrounds, cultures, religions, political and/or sexual orientations, and work together, to fight the world’s most threatening diseases and enable access to care, united by one purpose: to pioneer breakthroughs in healthcare. For everyone. Everywhere. Sustainably. To find out more about Healthineers’ specific businesses, please visit our company page here.

Data Privacy

We care about your data privacy and take compliance with GDPR as well as other data protection legislation seriously. For this reason, we ask you not to send us your CV or resume by email. We ask instead that you create a profile where you can upload your CV. Setting up a profile also lets us know you are interested in career opportunities with us and makes it easy for us to send you an alert when relevant positions become open.

As an equal opportunity employer, we welcome applications from individuals with disabilities.

As an equal opportunity employer, we welcome applications from individuals with disabilities.

We are a team of 72,000 highly dedicated employees across more than 70 countries passionately pushing the boundaries of what’s possible in healthcare to help improve people’s lives around the world.