KMOL Plastics Engineering
Manufacturing Quality Engineer – Medical Injection Molding
KMOL Plastics Engineering, Hayward, California, us, 94557
Manufacturing Quality Engineer – Medical Injection Molding
Direct message the job poster from KMOL Plastics Engineering
Lean/KAIZEN/CI lifelong learning enthusiast with honest, energetic leadership that is passionate, team synergistic, and collaborative. I take pride…
Summary
The Manufacturing Quality Engineer ensures that injection-molded medical device components meet regulatory, customer, and internal quality requirements. This role drives continuous improvement in manufacturing processes, supports validation activities, and partners with cross‑functional teams to maintain compliance with ISO 13485, FDA cGMP, and customer specifications.
Work Culture
Highly inspired by the Toyota Production System (TPS) and Ji Kotei Kanketsu (JKK) operations mindset
Fostering a culture of quality, accountability, and continuous improvement within the manufacturing team
Promoting open communication, collaboration, and knowledge sharing across departments
Encouraging proactive problem‑solving and employee engagement in quality initiatives
Supporting ongoing training and professional development to build expertise and confidence
Upholding ethical standards and compliance with regulatory requirements in all activities
Recognizing and celebrating team achievements and milestones to boost morale and motivation
Key Responsibilities
Consistently focusing on improving existing quality systems for injection molding operations in compliance with ISO 13485 and ISO 9001 regulations
Collaborate with the team to establish robust process controls, inspection methods, and acceptance criteria
Conduct root cause analysis and implement corrective and preventive actions (CAPA) to address nonconformances
Monitor key quality metrics (scrap, yield, complaints, deviations) and aggressively drive continuous improvement initiatives
Author and maintain quality documentation, including work instructions, inspection plans, and validation protocols
Provide technical support for customer audits, regulatory inspections, and supplier quality management
Train operators and technicians on quality standards, visual inspection criteria, and GMP practices
Assist process engineering in the process validation (IQ/OQ/PQ) for new molds, tooling, and equipment
Qualifications and Preferred Skills
Curious, continuous learning mindset
Bachelor’s degree in Engineering (Mechanical, Manufacturing, Plastics, or related field) or equivalent work experience
Strong mechanical aptitude and organizational abilities
1-3 years of experience in quality engineering, preferably in medical device injection molding
Strong knowledge of ISO 13485, ISO 9001, and GMP requirements
Experience with scientific molding principles, validation protocols, and statistical process control (SPC)
Proficiency in root cause analysis tools (5 Whys, Fishbone, DOE) and risk management (FMEA)
Excellent communication, documentation, and cross‑functional collaboration skills
Experience with ERP/MES systems and electronic quality management systems (eQMS).
Familiarity with cleanroom manufacturing and Class II/III medical devices.
Seniority level
Entry level
Employment type
Full‑time
Job function
Engineering and Information Technology
Plastics and Rubber Product Manufacturing
Get notified about new Manufacturing Quality Engineer jobs in
Hayward, CA .
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Lean/KAIZEN/CI lifelong learning enthusiast with honest, energetic leadership that is passionate, team synergistic, and collaborative. I take pride…
Summary
The Manufacturing Quality Engineer ensures that injection-molded medical device components meet regulatory, customer, and internal quality requirements. This role drives continuous improvement in manufacturing processes, supports validation activities, and partners with cross‑functional teams to maintain compliance with ISO 13485, FDA cGMP, and customer specifications.
Work Culture
Highly inspired by the Toyota Production System (TPS) and Ji Kotei Kanketsu (JKK) operations mindset
Fostering a culture of quality, accountability, and continuous improvement within the manufacturing team
Promoting open communication, collaboration, and knowledge sharing across departments
Encouraging proactive problem‑solving and employee engagement in quality initiatives
Supporting ongoing training and professional development to build expertise and confidence
Upholding ethical standards and compliance with regulatory requirements in all activities
Recognizing and celebrating team achievements and milestones to boost morale and motivation
Key Responsibilities
Consistently focusing on improving existing quality systems for injection molding operations in compliance with ISO 13485 and ISO 9001 regulations
Collaborate with the team to establish robust process controls, inspection methods, and acceptance criteria
Conduct root cause analysis and implement corrective and preventive actions (CAPA) to address nonconformances
Monitor key quality metrics (scrap, yield, complaints, deviations) and aggressively drive continuous improvement initiatives
Author and maintain quality documentation, including work instructions, inspection plans, and validation protocols
Provide technical support for customer audits, regulatory inspections, and supplier quality management
Train operators and technicians on quality standards, visual inspection criteria, and GMP practices
Assist process engineering in the process validation (IQ/OQ/PQ) for new molds, tooling, and equipment
Qualifications and Preferred Skills
Curious, continuous learning mindset
Bachelor’s degree in Engineering (Mechanical, Manufacturing, Plastics, or related field) or equivalent work experience
Strong mechanical aptitude and organizational abilities
1-3 years of experience in quality engineering, preferably in medical device injection molding
Strong knowledge of ISO 13485, ISO 9001, and GMP requirements
Experience with scientific molding principles, validation protocols, and statistical process control (SPC)
Proficiency in root cause analysis tools (5 Whys, Fishbone, DOE) and risk management (FMEA)
Excellent communication, documentation, and cross‑functional collaboration skills
Experience with ERP/MES systems and electronic quality management systems (eQMS).
Familiarity with cleanroom manufacturing and Class II/III medical devices.
Seniority level
Entry level
Employment type
Full‑time
Job function
Engineering and Information Technology
Plastics and Rubber Product Manufacturing
Get notified about new Manufacturing Quality Engineer jobs in
Hayward, CA .
#J-18808-Ljbffr