Quality Assurance Engineer I - Medical Device Manufacturing

Micro Stamping Corporation•Somerset, NJ

47d•Onsite

About The Position

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 limits, manage customer complaints and corrective actions, and keep scrap below the maximum percent of sales. This role involves research, analysis, and auditing of production processes, as well as performing quality assurance testing and troubleshooting.

Requirements

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.
Blueprint reading and interpretation
Gage design knowledge
APQP
MSA
PPAP
SPC
GD & T
Automated inspection software
MS Office Suite
Manual dexterity
Spatial dexterity
Problem solving
Root cause analysis
Corrective Action
Multitasking
Written communication
Verbal communication
Organizational skills
Time Management
Regularly required to stand; walk; sit; use hands to finger, handle, or feel; reach with hands and arms; and talk and hear.
Occasionally required to stoop, kneel, crouch, or crawl.
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.
Regularly required to demonstrate manual and spatial dexterity sufficient to operate machinery for precision work.
Regularly exposed to moving mechanical parts and vibration.
Frequently exposed to risk of electrical shock.
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.

Nice To Haves

ASQ certification is preferred

Responsibilities

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.
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.
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.