Overview
Quality Control (QC) Engineer – Medical Device Jobs in New Jersey, United States at EnIn Systems
Title: Quality Control (QC) Engineer – Medical Device
Company: EnIn Systems
Location: New Jersey, United States
experience: 8+ years only
Key Responsibilities:
Perform in-process and final product inspections to ensure compliance with product specifications and regulatory requirements.
Develop and implement quality control procedures, work instructions, and inspection criteria.
Investigate and document non-conformances (NCRs), lead root cause analyses, and support corrective and preventive actions (CAPA).
Support process validations (IQ/OQ/PQ) and product validations in accordance with FDA, ISO 13485, and other applicable standards.
Collaborate with R&D, manufacturing, and quality assurance teams to resolve quality issues and improve product quality.
Review and approve device history records (DHRs), test reports, and inspection data.
Utilize tools like calipers, micrometers, CMM, or vision systems for product measurements.
Maintain accurate and complete quality control documentation and records.
Participate in internal and external audits as needed.
Required Skills:
Experience in quality control/inspection within the medical device industry.
Good understanding of FDA QSR (21 CFR Part 820), ISO 13485, and ISO 14971.
Proficiency with measurement tools and inspection equipment.
Familiarity with quality tools like FMEA, control plans, statistical process control (SPC).
Strong documentation, analytical, and problem-solving skills.
Ability to interpret engineering drawings, specifications, and procedures.
Preferred Qualifications:
Experience with electromechanical or disposable medical devices.
Knowledge of Six Sigma, Lean Manufacturing, or related methodologies.
Certification in CQE (Certified Quality Engineer) or CQA (Certified Quality Auditor) is a plus.
Experience with ERP and QMS software.
Key Responsibilities:
Perform in-process and final product inspections to ensure compliance with product specifications and regulatory requirements.
Develop and implement quality control procedures, work instructions, and inspection criteria.
Investigate and document non-conformances (NCRs), lead root cause analyses, and support corrective and preventive actions (CAPA).
Support process validations (IQ/OQ/PQ) and product validations in accordance with FDA, ISO 13485, and other applicable standards.
Collaborate with R&D, manufacturing, and quality assurance teams to resolve quality issues and improve product quality.
Review and approve device history records (DHRs), test reports, and inspection data.
Utilize tools like calipers, micrometers, CMM, or vision systems for product measurements.
Maintain accurate and complete quality control documentation and records.
Participate in internal and external audits as needed.
Required Skills:
Experience in quality control/inspection within the medical device industry.
Good understanding of FDA QSR (21 CFR Part 820), ISO 13485, and ISO 14971.
Proficiency with measurement tools and inspection equipment.
Familiarity with quality tools like FMEA, control plans, statistical process control (SPC).
Strong documentation, analytical, and problem-solving skills.
Ability to interpret engineering drawings, specifications, and procedures.
Preferred Qualifications:
Experience with electromechanical or disposable medical devices.
Knowledge of Six Sigma, Lean Manufacturing, or related methodologies.
Certification in CQE (Certified Quality Engineer) or CQA (Certified Quality Auditor) is a plus.
Experience with ERP and QMS software.
