Quality Assurance Engineer I - Medical Device Manufacturing

HireLifeScience; Franklin Township (NJ); On-site; USD 94,000 - 101,000; Full time

Benefits offered by this job

Medical, dental and vision insurance

401(k) retirement plan

Paid time off

Paid holidays

Job summary

HireLifeScience seeks a Quality Assurance Engineer I to analyze production inputs and outputs to ensure customer quality requirements are met. You will support process stability, FMEA, DOE, and SPC analyses and help drive continuous improvement.

The role requires a Bachelor's degree in Engineering and 2–4 years of quality experience in manufacturing, with ASQ certification preferred. On-site work in New Jersey is expected.

Qualifications

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

Responsibilities

• Perform process stability and capability studies and analyze quality data.
• Conduct FMEA, DOE, and SPC analyses and document results.
• Lead root cause investigations and develop corrective action plans.
• Write detailed work instructions and train personnel.
• Monitor quality-related KPIs and support continuous improvement.

Skills

Statistical analysis

Root cause analysis

Problem solving

Written communication

Verbal communication

Organizational skills

Time management

Multitasking

Gage design knowledge

APQP

MSA

PPAP

SPC

GD & T

Education

Bachelor’s degree in Engineering or related field

ASQ certification preferred

Tools

MS Office Suite

Automated inspection software

Job description

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
• Gage design knowledge
• APQP
• MSA
• PPAP
• SPC
• GD & T
• Automated inspection software
• MS Office Suite

OTHER SKILLS

• Manual dexterity
• Spatial dexterity
• Problem solving
• Root cause analysis
• Corrective Action
• Multitasking
• Written communication
• Verbal communication
• Organizational skills
• Time Management

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 sufficient to operate machinery for precision work

While performing the duties of this Job, the employee is regularly exposed to moving mechanical parts and vibration. The employee is frequently exposed to risk of electrical shock. The employee is occasionally exposed to wet and/or humid conditions and odors, dusts, mists, fumes and/or airborne particles.

The noise level in the work environment is usually moderate.

Compensation & Benefits

The anticipated hiring range for this position is $94,000 to $101,000 annually. Actual compensation within this range will be determined based on relevant skills, experience, education, and other job-related qualifications.

Based on a candidate’s qualifications and experience, they may be considered for other available opportunities at a different level. Compensation for any such position would be based on the requirements and compensation range applicable to that position.

MICRO offers a comprehensive benefits package to eligible employees, including medical, dental and vision insurance; life and disability insurance; a 401(k) retirement plan; paid time off; paid holidays; and other company-sponsored benefits. Eligibility and benefit offerings are subject to the terms of the applicable plans and company policies.