mudasir maldar
@mudasirmaldar
Senior Supplier Quality Engineer improving medical device supplier quality through ISO/FDA QMS and continuous improvement.
What I'm looking for
I’m a results-driven Senior Supplier Quality Engineer with 10+ years of experience across medical device and precision manufacturing. I build and optimize global supplier quality strategies that keep products compliant, stable, and ready for launch.
In my current role, I partner with contract manufacturers and sub-tier suppliers to ensure quality requirements are met and production stays uninterrupted. I lead supplier qualification through APQP and PPAP, review supplier process documentation (process flow diagrams, control plans, and pFMEAs), and drive risk mitigation using PPRA and validation principles (IQ/OQ/PQ, V&V). I also lead SCAR/CAPA closure—using root cause analysis, weekly SCAPA reviews, and KPI-driven supplier performance improvements—while managing documentation and change control through Agile PLM, Jira, and related tools.
Before this, I co-founded and served as QA Lead for a precision engineering organization, where I established end-to-end quality processes for mold manufacturing from prototype to production. Using Six Sigma (DMAIC), SPC, first article inspections, and IQ/OQ/PQ validations, I reduced lead time by 15%, improved machining consistency by 15%, and increased customer satisfaction by 20% through supplier audits, supplier scorecards, FMEA, control plans, and gage R&R.
Earlier in my career, I’ve also led operational and planning responsibilities, coordinating quality plans, inspection test plans, and continuous improvement using PDCA and Lean tools. Across all roles, my professional ethos stays the same: strengthen supplier QMS (ISO 13485, FDA 21 CFR Part 820) and deliver measurable quality excellence across Class I–III medical devices.
Experience
Work history, roles, and key accomplishments
Partner with contract manufacturers and sub-tier suppliers to ensure compliance with quality requirements and support uninterrupted production. Lead supplier qualification (APQP/PPAP), review process documentation (control plans, pFMEAs), and manage SCAPA/CAPA using root-cause analysis.
Co-Founder & QA Lead
AK Precision Engineering
May 2021 - Jun 2022 (1 year 1 month)
Established and led quality processes for mold manufacturing from prototype to production, reducing lead time by 15%. Implemented Six Sigma (DMAIC), SPC, first article inspections, and IQ/OQ/PQ validations, and drove supplier audits, FMEA/control plans, and customer complaint-driven corrective actions.
Site In-charge
Cape East General Contracting WLL
Jan 2018 - Apr 2021 (3 years 3 months)
Managed end-to-end site operations including planning, resource allocation, budgeting, and scheduling. Reviewed site quality and inspection plans, coordinated with clients on progress and scope variations, and used PDCA/Lean tools to drive continuous improvement and meet project milestones.
Planning Engineer
KAEFER ISOLIERTECHNIK GMBH
Jan 2014 - Aug 2016 (2 years 7 months)
Prepared and maintained project work schedules, progress reports, and manpower mobilization plans. Coordinated invoicing, performed variance analysis, and supported client meetings for schedule reviews, issue resolution, and resource planning.
Education
Degrees, certifications, and relevant coursework
University of Mumbai
Bachelor of Engineering, Mechanical Engineering
2009 - 2012
Bachelor of Engineering in Mechanical Engineering from the University of Mumbai in Maharashtra, India (2009–2012).
Availability
Location
Authorized to work in
Job categories
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