Quality Assurance Engineer II - Medical Device

Micro Stamping Corporation•Somerset, NJ

3d•Onsite

About The Position

The Quality Assurance Engineer II is responsible for conducting complex ongoing analysis of the production process inputs and outputs to ensure that customer quality requirements are being achieved. This position has no talent management responsibilities.

Requirements

Bachelor’s degree in Engineering or a related field is required.
At least 4-7 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
Lean
Six Sigma
MS Office Suite
Manual dexterity
Spatial dexterity
Problem solving
Root cause analysis
Corrective Action
Multitasking
Written communication
Verbal communication
Organizational skills
Time Management

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.
Performs complex data analysis and uses six sigma tools to resolve complex quality issues.
Provides input to the production control systems and designs control activities.
Provides input for new product equipment selection, installation and maintenance.
Maintains expert level of understanding of GD&T.
Leads investigations to determine root cause, development of corrective action plans, verification and effectiveness activities.
Use appropriate statistical techniques to analyze data and make/recommend decisions.
Leads projects, teams and complex product transitions.
Provides mentorship and support to team members.
Develops quality standards and processes related to customer specifications and process improvement.
Communicates with customers, suppliers and other resources to achieve the objectives.
Works with customers to understand product specifications and satisfies any quality related issues or concerns.
Evaluates process stability and capability.
Analyzes processes and procedures to ensure they fit the organization’s quality standards.
Ensures quality processes and procedures comply with internal SOPs.
Assists with regulatory audits.
Performs inspections and sets quality assurance testing models for analysis of raw materials, materials in process, and finished products.
Provides communication to Calibration Technicians of any additions, deletions, or changes to the process gages and equipment.
Writes detailed work instruction-level documents for Quality and related areas.
Trains personnel in these instructions and other technical process controls.
Quarantines, documents and evaluates products and materials and generates Material Review Board (MRB) Case(s) as appropriate.
Ensures control plans and associated documentation are implemented effectively and maintained.
Monitors and reports on quality-related key performance indicators.
Ensures compliance and assists with adherence to quality management system.
Writes product test procedures and performs IQ/OQ/PQ protocol.