Quality Engineer

SUMMARY/PURPOSE
This position is responsible for supporting quality engineering activities.

This includes participation in the development of new products and processes through commercialization, validation, change management and root cause investigations.

Works with various departments to investigate customer complaints.

Develops, modifies, applies and maintains quality standards and generates protocols and reports.

Works directly with the quality technicians on product evaluations during the production process, analyzes data from inspection reports and resolves quality problems.

Ensures production has the necessary documentation for production runs.

ESSENTIAL DUTIES AND RESPONSIBILITIES
• Act in conjunction with Quality Manager as a technical contact on quality related issues for internal and external customers.
• Respond quickly to customer quality issues including performing investigations, apply root cause analysis and problem solving techniques to address concerns.

Investigate and document customer non-conformances and corrective actions.
• Follow Lean Six Sigma (DMAIC) methodology to determine root cause of problems and implement sound corrective action.
• Development and implementation of quality system documentation and maintenance.
• Responsible for leading validation of new gauging equipment, new process equipment and products.

• Working knowledge of process flow maps / diagrams, control plans and measurement system evaluations in support of standard requirements.
• Assist in audits (internal and external) by third party registrars and / or customers and maintaining the ISO 9001 and ISO 13485 procedures and work instructions.
• All other duties as assigned.

QUALIFICATIONS / EDUCATION / EXPERIENCE

• Bachelor’s degree in a related engineering field such as mechanical, industrial or chemical is required with 5+ years in a Quality Engineering role.
• At least 2+ years validation experience in a manufacturing environment.
• Lean Six Sigma is required; certification is a plus.
• Experience with ISO 13485
• Ability to independently apply analytical skills, complex scientific technical principles and detailed knowledge in solving engineering problems.
• Clear understanding and application of DOE, DFMEA and PFMEA methodologies.
• Experience with Statistical Process Control methods (control charts, CpK’s, etc.).
• Knowledge of Good Manufacturing Practices (GMP’s) encompassing plastics extrusion lines, calculations of speeds, material composition understanding, comprehension of the basic function of fixtures and familiarity with inspecting and checking methods.
• Proficient in Gauge R & R metrology.

Ability to read and interpret prints and tool designs.
• Ability to troubleshoot / solve problems independently or as part of a team.
• Excellent verbal and written communication skills.

Ability to, internally and externally, discuss and clearly define key technical and process development issues an...