Regulatory Affairs and Quality Assurance Engineer

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.

The RA/QA Engineer typically serves as the quality representative on the project team and works closely with the project team leader.

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 domestic and international requirements.

Provides support and typically works as a member of one or more new product development and/or sustaining engineering projects.

Major On-going Responsibilities For, 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.

Quality Engineering Ownership

• Phase End Design Reviews – drives compliance of the review, reviews document and provides DHF reviews.
• Provides Software Summary Assessment
• Provides Post Market surveillance and customer complaint data for design inputs including; Complaints, CAPAs, Journals, Customer Surveys and Audit Findings.

Obtains and distributes on-going metrics for review by relevant teams:

• ECN – post launch (not continuous improvements)
• Number of Recalls – by type
• Number of Discrepancy Reports (by priority and phase discovered)
• Complaint analysis as pertaining to Design Control
• Tracking of scheduled delays (length / cause)

Provides Quality Reviews For

• Phase End Design Reviews – drives compliance of the review, reviews document and provides DHF reviews.
• Provides Software Summary Assessment
• Provides Post Market surveillance and customer complaint data for design inputs including; Complaints, CAPAs, Journals, Customer Surveys and Audit Findings.
• Obtains and distributes on-going metrics for review by relevant teams:
• ECN – post launch (not continuous improvements)
• Number of Recalls – by type
• Number of Discrepancy Reports (by priority and phase discovered)
• Complaint analysis as pertaining to Design Control
• Tracking of scheduled delays (length / cause)

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 analyze 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 healthcare software lifecycle phase like design and development, testing, or customer facing activities.
• Experience of healthcare software (medical device software 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.
• Experience of working with healthcare provider that follows ISO 13485, ISO 14971, IEC 62304, FDA QSR 21 CFR 820, EU Directive 93/42 EEC, EU MDR 2017/745, MDSAP or similar medical device regulations.
• Professional certification (i.e. SQA-Software Quality Assurance, Certified Internal/Lead Auditor for ISO is added advantage.
• 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 73,000 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.

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