Experience Range: 5 -7 Years in Medical Device manufacturing domain experience (Mandatory)
Specific industry experience: Medical Device and HealthCare
Qualification: Bachelor’s degree in Mechanical Engineering / Industrial engineering background
Skill Requirement:
? Hands-on experience in gap assessment and remediation of DHF & DMR documents in
alignment with Quality Management System (QMS), applicable standards and procedures.
? Experience in process validation (IQ/OQ/PQ) execution and documentation for medical devices
? Experience in root cause investigation for validation failures, manufacturing issues, or design
issues
? Demonstrated experience in mitigating, identifying, and resolving manufacturing and test method
issues (NCR/CAPA)
? Demonstrated application of engineering principles in projects and cross functional collaboration.
? Experience with tools such as Minitab, SAP, Agile, Trackwise, etc.
? Strong knowledge in Statistical Process Control (SPC), Design of Experiments (DoE), Process
control Plans, Sampling methodologies, MSA/Gage R&R, statistical data analysis and PFMEA
? Strong analytical skills in Root Cause Investigations, CAPA, Six Sigma and continuous
improvement.
? Proficient in interpreting technical part drawings and GD&T principles.
? Good understanding of FDA 510 K, ISO 13485 & ISO 14971 standards
? Ability to work effectively in a fast paced, team-oriented environment.
? Ability to multi-task and lead/manage projects methodically.
Roles & Responsibilities:
? Create or modify process flow diagrams within the Manufacturing and Service Departments.
? Perform gap assessments and remediate DHF & DMR documents in alignment with Quality
Management System (QMS), applicable standards and procedures.
? Develop and maintain Manufacturing/Service Work Instructions and related documentation.
? Create validation strategy and execute IQ/OQ/PQ for fixtures, tooling, and equipment in
coordination with onsite team.
? Design and develop fixtures, tooling, equipment and systems to support operations.
? Understand the Essential Design outputs and create Design Transfer review documents.
? Interpret product drawings to determine part specific requirements.
? Identify, investigate, and resolve operational issues to improve First Pass Yield and reduce waste.
? Review and update the Process Failure Mode and Effects Analysis (PFMEA) to reflect on the
latest manufacturing processes and procedures, ensuring alignment with current operational
standards and risk mitigation strategies.
? Drive corrective action and continuous improvement initiatives through data analysis and root
cause investigations.
? Support Corrective and Preventive Actions in manufacturing using formal problem-solving tools
and documentation.
JobzAlly, the Consultant Engine is owned by JobzAlly, a company incorporated under the laws of India with company registration number (AKL/YAD/CE/0011/2023) and MSME - Udyog Aadhaar Number (UDYAM-KR-03-0346259) and having its registered office at #D6, Raghavendra Swamy Layout, Opposite to Guest Line Hotel, Yedavanahalli, Bengaluru – 562107, Karnataka, India. JobzAlly, hereinafter, referred to as the "Company". The terms “We”, “Us” or “Our” shall mean the “Company”.
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