Quality Assurance Engineer II - Medical Device

Micro; Franklin Township (NJ); On-site; USD 110,000 - 123,000; Full time

Benefits offered by this job

Medical, dental and vision insurance

401(k) retirement plan

Paid time off

Paid holidays

Job summary

Micro is seeking a Quality Assurance Engineer II for a medical device environment. The role focuses on analyzing production data, maintaining SPC targets, and reducing customer complaints while driving corrective actions and process improvements.

The position requires a Bachelor's degree in Engineering or related field and 4–7 years of manufacturing quality experience, with ASQ certification preferred. This is an on-site, full-time role based in Somerset, NJ and offers a comprehensive benefits

Qualifications

• Bachelor’s degree in Engineering or a related field is required.
• At least 4–7 years of quality experience in manufacturing or equivalent.
• ASQ certification is preferred.

Responsibilities

• Maintain SPC limit at or above the corporate target.
• Keep customer complaints to or below the previous year.
• Manage CAR containment and root cause investigation, corrective action plan and on-time completion.
• Maintain scrap below the maximum percent of sales identified.
• Lead investigations to determine root cause and develop corrective actions.
• Write product test procedures and ensure quality documentation.

Skills

Problem solving

Root cause analysis

Corrective Action

Organizational skills

Analytical thinking

Team Player

Innovative

Motivations

Education

Bachelor’s degree in Engineering or related field

ASQ certification preferred

Tools

Blueprint reading and interpretation

Automated inspection software

Job description

Quality Assurance Engineer II - Medical Device

Job Category: Quality

• Full-Time
• On-site

Locations

Somerset, NJ 08873, USA

Description

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
• Perform 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
• 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 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.

The anticipated hiring range for this position is $110,000 to $123,000 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.

Qualifications

Skills

Required

Manufacturing Environment Experience

Intermediate

GD and T

Novice

Experience with SPC

Intermediate

Ability to read and interpret documents

Novice

Analytical thinking

Intermediate

Behaviors

Required

Team Player

Works well as a member of a group

Innovative

Consistently introduces new ideas and demonstrates original thinking

Motivations

Required

Ability to Make an Impact

Inspired to perform well by the ability to contribute to the success of a project or the organization

Self-Starter

Inspired to perform without outside help

Equal Opportunity Employer
This employer is required to notify all applicants of their rights pursuant to federal employment laws. For further information, please review the Know Your Rights notice from the Department of Labor.