Karpagam Manivannan
Product Quality Manager | Apple | Quality & Reliability
San Jose
Summary
Results-driven Hardware Quality Engineer with 12+ years at Apple, Illumina, GE, and Whirlpool spanning medical devices, consumer electronics, and Transportation. Deep expertise in product quality engineering, manufacturing process validation, IQC/IPQC/OQC, metrology, and regulatory compliance (ISO 13485, FDA 21 CFR Part 820). Proven track record of driving yield improvement, CAPA resolution, and NPI-to-mass production readiness in high-volume precision manufacturing. Certified Medical Device Auditor and ISO 13485 Lead Auditor. Consistently drives Quality transformation through AI/ML, anomaly detection, and data visualization- delivering measurable impact at scale.
Overview
13
13
years of professional experience
4
4
Certifications
Work History
Product Quality Manager
Apple Inc.
10.2022 - Current
- Established IQC, IPQC, and OQC inspection plans for NPI and MP builds, defining dimensional, cosmetic, and functional acceptance criteria to ensure zero-defect product delivery at scale.
- Drove proactive XFMR TA audit program co-developed with Safety, EE, and vendor — implementing SARL audits across all PSU magnetic components for early detection of potential failures, achieving 0% magnetics-related sustaining hipot failures at FATP.
- Drove vendor yield improvements and measurement system correlation between suppliers and Apple, reducing inter-site variability and ensuring supply chain data integrity.
- Deployed AI/ML-based AOI for Mac Studio PSU production, achieving 60% improvement in defect detection efficiency and reducing direct labor by 2 headcount — piloted at EVT build.
- Screened 1M+ units in 2–3 days using anomaly detection software, replacing manual inspection— delivering $5.2M+ in combined cost avoidance, quality improvement, and faster time-to-market.
- Built a real-time Quality Dashboard in Tableau (self-trained) integrating field, NPI, and sustaining defect data from vendors and IR, improving reporting time efficiency by 70% and enabling faster, data-driven decisions across engineering and quality teams.
- Developed Power AI chatbot working with AI/ML team providing instant access to product timelines, failure analysis, root causes, and lessons learned — reducing information retrieval time by 80–90% and accelerating problem resolution by 40–60% by surfacing historical failure modes to prevent recurrence.
Supplier Quality Engineering Manager
Illumina
06.2018 - 10.2022
- Led supplier quality through medical device NPI platforms, ensuring compliance with ISO 13485 and FDA 21 CFR Part 820.
- Reduced supplier audit findings by 60% through a supplier maturity model and targeted CAPA programs.
- Saved $500K annually via risk-based incoming inspection, eliminating redundant inspection for qualified suppliers.
- Partnered with suppliers to optimize material specs, improve manufacturing controls, and enhance component reliability for genomic sequencing instruments.
Supplier Quality Engineer – Electronics
GE Transportation
01.2015 - 01.2018
- Developed PPAPs, PFMEAs, and Control Plans for electronics components in high-reliability systems.
- Conducted supplier scorecards and annual audits to drive continuous improvement in quality and delivery performance.
Electronics & Controls Design Quality Engineer
Whirlpool Corporation
10.2012 - 12.2014
- Ensured DFMA/DFT compliance across the full product lifecycle for electronics and controls systems.
- Led root cause analysis for production and field failures, driving design and process improvements to reduce warranty costs.
- Supported PPAP, software validation, and manufacturing process readiness for NPI.
Education
M.S. - Electrical & Computer Science Engineering
University of Toledo
OHDiploma in Embedded System Design - undefined
CDAC
IndiaB.S. - Electrical Engineering
Anna University
IndiaSkills
Manufacturing Process & Equipment Qualification
Metrology, Reliability Testing & Failure Analysis
SPC, FMEA, CAPA, Six Sigma, Lean, Kaizen
ISO 9001, ISO 13485, Medical Device Compliance
New Product Introduction (NPI) & Mass Production Readiness
Supplier Audits & Supplier Development
Cross-functional Leadership & Program Management
Data Analysis, DOE, Process Capability Studies
Websites
Certification
ASQ Certified Manager of Quality/Organizational Excellence
Timeline
Product Quality Manager
Apple Inc.
10.2022 - Current
Supplier Quality Engineering Manager
Illumina
06.2018 - 10.2022
Supplier Quality Engineer – Electronics
GE Transportation
01.2015 - 01.2018
Electronics & Controls Design Quality Engineer
Whirlpool Corporation
10.2012 - 12.2014
Diploma in Embedded System Design - undefined
CDAC
B.S. - Electrical Engineering
Anna University
M.S. - Electrical & Computer Science Engineering
University of Toledo