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Senior Quality Engineer - Trenton, United States - Micro Manufacturing Solutions for Life
Description
Senior Quality Engineer - Medical Device
Do you want to make a difference in the world? Do you want to help save lives? Come start or continue your career with us MICRO is a contract manufacturer providing services for companies engaged in life-saving products and solutions.
MICRO offers an excellent benefits package, compensation higher than industry average and a full complement of training programs dedicated to give our employees the skills and knowledge required to achieve their career goals.
Are you ready to?
MISSION
The Senior Quality Assurance Engineer is responsible for conducting complex ongoing analysis of the production process inputs and outputs to ensure that customer quality requirements are being achieved.
ESSENTIAL DUTIES AND RESPONSIBILITIES
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.
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.
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
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.
OTHER QUALIFICATIONS
ASQ certification is preferred
KNOWLEDGE & SKILLS
EDUCATION AND EXPERIENCE
Bachelor's degree in Engineering or a related field is required.
6+ years of quality experience in a manufacturing environment or equivalent combination of education and experience is required.
Experience reading and interpreting blueprints and gage design knowledge is required.
Experience with GD&T is required.
Experience with automate inspection systems is required.
Proficient in common quality methodologies, including: APQP, MSA, PPAP, SPC.
Strong manual and spatial dexterity skills is required.
Experience with Lean and Six Sigma methodologies is preferred.
Implementation of effective corrective action is strongly preferred.
Ability to work multiple projects.
Strong verbal and written communication skills as well as excellent interpersonal skills are required
Must have exceptional organizational skills, ability to meet deadlines, thrive in a fast-paced environment and be able to problem solve effectively.
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