Quality Assurance Engineer - Medical Device Manufacturing

Quality Assurance Engineer I - Medical Device Manufacturing

Job Category: Quality

Requisition Number: QUALI
002033

• Posted :
  September 22, 2026
• Full-Time
• On-site

Showing 1 location

Somerset, NJ 08873, USA

The Quality Assurance Engineer I is responsible for conducting ongoing analysis of the production process inputs and outputs to ensure that customer quality requirements are being achieved.

The Quality Engineer I is expected to:

• Maintain SPC limit at or above the corporate target.
• Keep customer complaints less than or equal to previous year
• Manage CAR containment and root cause investigation, corrective action plan and completions on time
• Maintain scrap below the maximum percent of sales identified

Research & Analysis

• Collects production data and applies standard scientific and statistical methods to analyze, document, and diagram production processes. Conducts FMEA, DOE, and SPC analysis
• Applies GD&T and measurement techniques to review and interpret part print design, quality and intention.
• Provides input to the production control systems and designs control activities
• Provides input for new product equipment selection, installation and maintenance
• Identifies opportunities for cost reduction and quality improvements.
• Audits work processes and evaluates any non-value-added activities or variations in the processes.
• Use appropriate statistical techniques to analyze data and make/recommend decisions
• Participates in root cause investigations and development of corrective action plans. Leads verification and effectiveness activities.
• Programs data collection software as needed and monitors SPC software.

Quality Assurance

• Performs process stability and capability studies.

• Analyzes, assesses, and provides recommendations for improving or simplifying manufacturing controls and/or inspection processes.

• Performs inspections and sets quality assurance testing models for analysis of raw materials, materials in process, and finished products.
• Writes detailed work instruction-level documents for Quality and related areas. Trains personnel in these instructions and other technical process controls
• Troubleshoots quality assurance equipment and processes.
• Quarantines, documents and evaluates products and materials and generates Material Review Board (MRB) Case(s) as appropriate.
• Provides communication to Calibration Technicians of any additions, deletions, or changes to the process gages and equipment
• Ensures control plans and associated documentation are implemented effectively and maintained.
• Monitors and reports on quality-related key performance indicators
• Contributes towards the companies’ quality policy and performance metrics

This position has no talent management responsibilities.

EDUCATION AND EXPERIENCE

• Bachelor’s degree in Engineering or a related field is required.
• 2-4 years of quality experience in a manufacturing environment or equivalent combination of education and experience is required.

LICENSE AND CERTIFICATION

• ASQ certification is preferred

TECHNICAL SKILLS

• Blueprint reading and interpretation
• Automated inspection software

OTHER SKILLS

• Problem solving
• Root cause analysis
• Corrective Action
• Organizational skills

While performing the duties of this Job, the employee is regularly required to stand; walk; sit; use hands to finger, handle, or feel; reach with hands and arms; and talk and hear. The employee is occasionally required to stoop, kneel, crouch, or crawl.

The employee must frequently lift, push, pull, carry and/or move up to 25 pounds.

Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception and ability to adjust focus.

While performing this Job, the employee is regularly required to demonstrate manual and spatial dexterity…