Senior Quality Engineer - Medical Device Franklin

Senior Quality Engineer - Medical Device

Franklin, Somerset County, NJ.

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.

• 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

• 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.
• 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.

• ASQ certification is preferred.

• Bachelor's degree in Engineering or a related field is required.
• 4 - 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.

Equal Opportunity Employer. This employer is required to notify all applicants of their rights pursuant to federal employment laws.