RAJESH MOHAPATRA
Manufacturing & Quality Engineer (Medical Device)
Bhadrakh,OR
Summary
Manufacturing & Quality Engineer with 12+ years of experience, including 7+ years in medical device manufacturing. Proven expertise in process optimization, regulatory compliance (FDA, ISO 13485, ISO 14971, GMP), validation, and quality assurance. Proven track record in cost reduction, Lean Six Sigma implementation, ERP/PLM systems, and cross-functional project management. Strong track record of collaborating with leading medical device companies to ensure compliance, improve quality, and deliver high-performance products. Experienced in working with global clients, audits, and multi-location teams to deliver high-quality, compliant, and efficient operations.
Skills
Quality & Compliance: ISO 13485, ISO 14971, 21 CFR 820, GMP, CAPA, FMEA, SPC, APQP, PPAP, Internal & External Audits
undefinedOverview
13
13
years of professional experience
4
4
Certifications
4
4
Languages
Work History
Manufacturing and Quality Engineer
Consure Medical
07.2024 - Current
- Improved production efficiency by 6% and reduced non-conformance rates by 12% through quality improvements and corrective action plans.
- Validate 7 new machines and 47 exisiting machines and maintained 100% compliance with medical device regulations.
- Implemented ERP-based scheduling, achieving 3% cost savings and better resource utilization.
- Collaborated with R&D to integrate quality considerations into early design stages, enhancing product durability and functionality.
- Partnered with cross-functional teams to resolve process bottlenecks and drive continuous improvement.
- Developed inspection plans based on design specifications, ensuring all critical dimensions and performance criteria were verified throughout the manufacturing process.
- Implemented statistical process control methodologies to monitor production trends, identify potential problems, and proactively address them before they escalate.
Senior Manufacturing Engineer
TCS (Johnson & Johnson)
08.2022 - 12.2022
- Delivered 33% of projects on time by streamlining resource allocation and planning.
- Implemented 15% new product features within strict compliance timelines.
- Improved client satisfaction by 21% through proactive communication and issue resolution.
- Streamlined change order processing by 20% using Windchill & Agile.
- Ensured compliance with UDI & Data Matrix standards for product traceability.
- Coordinated with global stakeholders for timely issue resolution and design updates.
- Reviewed products for compliance with Design for Manufacturing (DFM) requirements.
Manufacturing Process Engineer
Straits Orthopaedics (Mfg.) Sdn. Bhd.
05.2019 - 06.2022
- Drove 17% efficiency gains and 8% cost savings via Lean and process optimization.
- Validated laser marking machines for medical device manufacturing, ensuring FDA & EU MDR compliance.
- Optimized production flow by designing and implementing efficient workstations and tooling solutions.
- Reduced customer complaints by 11% through preventive quality controls.
- Implemented OEE programs, improving equipment effectiveness by 17% and reducing costs by 6%.
- Assisted in capacity planning efforts by providing accurate data on cycle times, throughput, and equipment utilization rates.
- Collaborated with Quality Assurance teams to troubleshoot non-conformances and develop corrective actions for root cause analysis findings.
Senior Manufacturing Engineer
Subros Limited
07.2012 - 04.2018
- Developed and launched 12 new products, reducing development cycle time by 10%.
- Increased production efficiency by 28% using Lean manufacturing methods.
- Reduced defects by 21% through strict quality inspections and CAD-based design accuracy.
- Implemented Kanban system, improving material flow and reducing delays.
- Mentored junior engineers, fostering a culture of continuous learning and professional growth within the team.
- Led value stream mapping exercises to identify areas of improvement within the end-to-end supply chain process, resulting in more effective inventory management practices.
- Developed standard operating procedures (SOP), ensuring consistent product quality and adherence to regulatory requirements.
Work Preference
Work Type
Full TimeLocation Preference
On-SiteRemoteHybridImportant To Me
Work-life balanceEducation
Diploma Engineering - Electronics & Telecommunication Engineering
B.S.E.T.
Bhadrak, Odisha05.2009
Bachelor of Engineering - Mechanical Engineering
D.I.B.M.T.
New Delhi, Delhi07.2012
Certification
AutoCAD for Design and Drafting from AUTODESK Design Academy
Work Availability
monday
tuesday
wednesday
thursday
friday
saturday
sunday
morning
afternoon
evening
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Quote
Your daily life is your temple and your religion.
Kahlil Gibran
Languages
English
Bilingual or Proficient (C2)
Hindi
Bilingual or Proficient (C2)
Odia
Bilingual or Proficient (C2)
Marathi
Bilingual or Proficient (C2)
Software
AutoCAD
Minitab
Solidworks
Timeline
Manufacturing and Quality Engineer
Consure Medical
07.2024 - Current
Senior Manufacturing Engineer
TCS (Johnson & Johnson)
08.2022 - 12.2022
Manufacturing Process Engineer
Straits Orthopaedics (Mfg.) Sdn. Bhd.
05.2019 - 06.2022
Senior Manufacturing Engineer
Subros Limited
07.2012 - 04.2018
Bachelor of Engineering - Mechanical Engineering
D.I.B.M.T.
Diploma Engineering - Electronics & Telecommunication Engineering
B.S.E.T.
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