Roles and Responsibilities
Execute design for manufacture and assembly by applying strong quality assurance, design control, and preventive quality practices.
Support new product and process development, ensuring quality deliverables are achieved during design transfer phases.
Collaborate with cross‑functional teams including Design, Advanced Operations, Supplier Quality, and Quality Assurance to ensure successful product launches.
Communicate effectively with internal stakeholders to ensure project transfers meet quality, timeline, and performance requirements.
Mentor cross‑functional teams on quality assurance concepts, especially in design and process transfer activities.
Risk Management
Apply risk management principles using tools like PFMEA to identify, evaluate, and mitigate process risks.
Support risk management file activities and ensure compliance with
ISO 14971
standards.
Assist design teams in identifying CQA/CTQ parameters and providing inputs to DFMEA.
Inspection & Quality Control
Develop and implement inspection strategies and plans using advanced inspection techniques.
Lead First Article Inspection (FAI) activities and ensure approval of inspection reports.
Drive continuous improvement in inspection methods and sampling techniques.
Develop and approve Measurement System Analysis (MSA) strategies.
Validation
Support development, execution, and approval of validation protocols and reports.
Promote validation-driven approaches over manual verification where possible.
Support sterilization validation activities where required.
Process Excellence
Apply statistical and quality tools to develop robust and scalable quality systems.
Support NC (Non-Conformance) and CAPA activities for new products.
Contribute to DFMA through process design optimization, tooling, and fixture development.
Drive benchmarking and human error reduction initiatives.
Supplier & Purchasing Quality
Support supplier qualification, validation, and PPAP approvals.
Assist in supplier selection and certification programs.
Support establishment of supplier quality agreements.
Design Transfer & Product Launch
Represent Quality Assurance in design transfer activities (DTAP process).
Participate in design reviews and ensure compliance with quality deliverables.
Support conversion of design outputs into production specifications.
Ensure smooth knowledge transfer and post‑launch quality support.
Implement containment strategies during pre‑release builds to prevent product escape.
Skills and Experience Required
Qualification: Bachelor’s Degree in Engineering or related field.
Experience: Minimum 2+ years in a regulated manufacturing environment; experience in new product/process introduction preferred.
Strong knowledge of quality assurance, design control, and manufacturing processes.
Experience with risk management tools such as PFMEA, DFMEA, and risk mitigation techniques.
Familiarity with APQP (Advanced Product Quality Planning) frameworks.
Understanding of medical device manufacturing processes and regulatory standards.
Knowledge of ISO 13485, QSR, GDP, GMP, and ISO 14971.
Experience in validation processes, including process and computer system validation.
Strong understanding of metrology, engineering drawings, and GD&T.
Knowledge of statistical tools, sampling plans, process capability, and MSA.
Familiarity with Lean Six Sigma methodologies (DMAIC) is an advantage.
Experience in supplier quality processes including PPAP and supplier validation.
Experience using quality and engineering tools for defect tracking, validation, and documentation.
Strong analytical and problem‑solving abilities.
Excellent planning, organizing, and multitasking skills.
Effective communication and interpersonal skills to collaborate with cross‑functional teams.
Ability to manage multiple projects simultaneously.
Continuous improvement mindset and adaptability to change.
Ability to act as the “voice of quality” across teams.
Proficiency in written and spoken English.
Location:
Gurugram, Haryana
