Quality Assurance Engineer I - Medical Device Manufacturing at MICRO in Somerset, NJ

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.
• 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

Responsibilities

• 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
• This position has no talent management responsibilities.

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.
• · ASQ certification is preferred
• · Blueprint reading and interpretation
• · Gage design knowledge
• · Automated inspection software
• · MS Office Suite
• · Manual dexterity
• · Spatial dexterity
• · Problem solving
• o Root cause analysis
• o Corrective Action
• · Multitasking
• · Written communication
• · Verbal communication
• · Organizational skills
• · Time Management
• Skills
• Required
• Experience with SPC
• Novice
• Data analysis & interpretation
• Intermediate
• Analytical thinking
• Intermediate
• Blueprint reading
• Novice
• GD and T
• Novice
• Behaviors
• Required
• Team Player: Works well as a member of a group
• Education
• Required
• Bachelors or better in Engineering.

Skills

Required

• Experience with SPC
• Data analysis & interpretation
• Analytical thinking
• Blueprint reading
• GD and T

Preferred

• ASQ certification

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.