Quality Engineer

Since 1976, TekniPlex Healthcare, located in Clayton, NC, has been producing medical tubing for a wide range of medical device applications including IV therapy, respiratory, dialysis, anesthesia, diagnostic and surgical equipment. We are actively recruiting for individuals who have a passion for producing a quality product that saves thousands of lives every day.

This position is responsible for supporting Quality Engineering activities for all aspects of product quality. 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 Team on product evaluations during the production process, analyzes data from inspection reports and resolves quality problems.

Quality Engineer

Primary Responsibilities and Expectations

• 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 13485 procedures and work instructions.
• All other duties as assigned.

Qualifications / Physical Demands

• Bachelor’s degree in a related engineering field such as mechanical, industrial or chemical is required with 5+ years in a Quality Engineering role.
• Lean Six Sigma is required; certification is a plus.
• 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 and independently develop course of action / plans.
• Excellent computer skills including Microsoft applications. Minitab or equivalent statistical software. Data base experience is a plus.
• Must be hands on and willing to work in production environment including off shifts when projects require.

We offer a full complement of valuable Health, Wellness, and Welfare benefits which include:

• PTO & 8 Company Holidays
• Medical, Dental, and Vision.
• Life and Disability.
• 401(k) and Match.
• Wellness Program including EAP.
• Pay for Performance philosophy.
• Medical benefits are effective on the first day of the month after being hired