Quality Assurance Engineer II - Medical Device

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.

The Quality Engineer II 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

· 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

Customer Support

• 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.

Quality Assurance

• 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.

This position has no talent management responsibilities.

EDUCATION AND EXPERIENCE

· 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.

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

· Lean

· Six Sigma

· MS Office Suite

OTHER SKILLS

· Manual dexterity

· Spatial dexterity

· Problem solving

o Root cause analysis

o 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.