R&d Sme Design Quality

Department
- MedTech Office
- Job posted on
- Oct 26, 2024
- Employment type
- P-P8-Probationer-HO Executive

**R&D SME Design Quality Engineering, Design Controls & Quality Management for Product Life Cycle Management (Manager/Sr.Mgr)**

**Job Description Summary**

Leads a team of Quality Assurance professionals and provides quality process support in accordance with medical device Quality Management System (QMS). This is a key leadership role responsible for the development, implementation, improvement and continuous reinforcement of established Quality Assurance fundamental practices that are utilized in the local business. The role involves hands-on work in quality and compliance activities around QMS processes as well as people leadership

Interprets simple internal and external business challenges and recommends best practices to improve products, processes or services. Stays informed of industry trends that may influence work.

**Job Description**:
**Roles and Responsibilities**
- Responsible for creating a Design Quality culture & SME from scratch by driving compliance activities around the end to end Product Life cycle Management, Design Controls, Design History File, Risk Management, Defect Management, V&V, Design Transfer to Manufacturing & Supply Chain.
- Hands on R&D Technical and cross functional leadership, able to communicate & articulate. Responsible to be able to work independently, hands-on in creating Design Quality Policy templates, Work instructions and the rest of the documentations.
- Responsible to create a culture of R&D Design quality assurance, Regulatory compliance and trust that enables this culture.
- R&D Design quality experiences of end to end Product Life Cycle Management covering Research/Advanced Development/New Product/Sustenance Engineering/Post Market/Customer Complaints, Investigations & Vigilances/Standards & Regulatory compliance & Submissions/IFU
- Ensures quality and regulatory compliance while driving process effectiveness and efficiency. Represents to external agencies and champions the evolution of the quality culture which includes executing and driving quality objectives, metrics, reporting and operating mechanisms.
- Established expertise within all Medical Device QMS processes.
- Has ability to organize, drive rigorous compliance of and lead a successful QMS processes at a medical device facility.
- Communicates complex messages and negotiates mainly internally with others to adopt a different point of view.
- Uses high level of judgment to make decisions and handle complex tasks or problems that impact the site’s compliance. Has ability to assess quality of information given and ask pertinent questions to stakeholders. Able to offer new solutions to problems outside of set parameters and is able to construct and provide recommendations. Uses multiple internal and some external sources outside of own function to help arrive at a decision.
- Ensures process compliance through the development of comprehensive procedures, work instructions, flowcharts, forms, templates, checklists, worksheets, and other product and process related documentation.

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**Required Qualifications**
- Bachelor's or Masters Degree. Minimum 10+ years’ experience in establishing Design Quality Control, Assurance, & competence development from the scratch within a regulated industry.
- Ability to effectively communicate technical information in English (both written and oral).
- Experiences in the understanding & interpretations of Audits, Audit Management, Design Controls Template creation from scratch, Risk Management, Design Controls, DHF, V&V, Standards & Regulations, CDSCO, FDA, MDSAP, etc for Class 2 and Class 3 devices
- Minimum 3 years of project management and Technical leadership experience

**Desired Characteristics**
- Experiences in developing Design Quality Engineering & Quality assurances for Cardiology, Nephrology, Imaging
- Strong leadership and communication skills. Previous project management experience is preferred.
- Demonstrated understanding or aptitude to understand Medical Device QMS requirements and regulatory requirements including but not limited to CDSCO, MDR, FDA CFR 21 820 and ISO 13485, ISO 14971, ISO 12417: 2024,ISO 25539:2020, MDSAP, etc.
- Demonstrated expertise to effectively communicate within all levels of the organization around concepts of design controls, production & process controls, Corrective & Preventive Action (CAPA), complaints & risk management.
- Demonstrated collaboration, negotiation & conflict resolution skills. Demonstrated ability to lead, acknowledge, develop, communicate & implement a strategy under crisis situations to ensure compliance. Experience in a global working environment.
- Experience leading and implementing change. Experience performing internal audits and participating in external audits.
- Exceptional analytical, problem solving & root-cause analysis skills. Ability to multi-task & handle tasks with competing