Lead Quality Control Engineer, Orthopedic Medical Devices

Onkos Surgical; Parsippany-Troy Hills (NJ); On-site; USD 110,000 - 140,000; Full time

Job summary

Onkos Surgical in Parsippany, NJ is seeking a Senior Quality Control Engineer to lead QC and inspection programs for orthopedic devices. You will drive advanced dimensional analysis, ensure compliance with FDA, ISO 13485 and GMP, and mentor junior staff to improve product reliability and manufacturing efficiency.

You will own QMS processes, CAPAs, NCRs, and validation activities, while collaborating with manufacturing, engineering and regulatory teams to prevent defects and sustain quality

Qualifications

• Bachelor’s degree in Quality Engineering, Mechanical Engineering, Biomedical Engineering, or related field (Master’s degree preferred).
• 5+ years of quality control experience in medical device, orthopedic, or precision manufacturing.
• Expertise in GD&T, blueprint reading, and SPC methodologies.
• Advanced proficiency in CMM programming and operation.
• Strong knowledge of ISO 13485, FDA regulations, GMP, and risk management (ISO 14971).
• Experience with process validation (IQ, OQ, PQ) and Gage R&R studies.
• Proficiency in quality management systems (QMS), Minitab, and ERP software.

Responsibilities

• Develop, implement, and optimize QC procedures and testing for orthopedic devices.
• Perform advanced dimensional analysis using CMMs, optical comparators, micrometers, calipers, and laser systems.
• Oversee FAI, incoming, in-process, and final inspections; apply GD&T to specifications.

Skills

GD&T

blueprint reading

SPC

CMM programming

ISO 13485

FDA regulations

GMP

risk management (ISO 14971)

IQ/OQ/PQ

Gage R&R

QMS

Minitab

ERP software

leadership

Education

Bachelor’s degree in Quality Engineering, Mechanical Engineering, Biomedical Engineering, or related field

Master’s degree preferred

Tools

CMM

Job description

Onkos Surgical in Parsippany, NJ is seeking a Senior Quality Control Engineer to lead QC and inspection programs for orthopedic devices. You will drive advanced dimensional analysis, ensure compliance with FDA, ISO 13485 and GMP, and mentor junior staff to improve product reliability and manufacturing efficiency.

You will own QMS processes, CAPAs, NCRs, and validation activities, while collaborating with manufacturing, engineering and regulatory teams to prevent defects and sustain quality