Quality Engineer

Quality Engineer

Technimark is a rapidly growing global manufacturer of custom rigid plastics solutions. Working in conjunction with some of the world’s most respected companies. With our corporate headquarters in Asheboro we create, design, and deliver products across multiple industry sectors including healthcare, packaging, industrial and consumer products for customers around the globe.

The Quality Engineer role will work at our plant designated to produce medical devices and healthcare products. In this role you'll collaborate with cross-functional teams, providing independent oversight and review of project deliverables throughout their lifecycle. Your contributions will span various domains, including manufacturing performance, employee development, technology and product development, environmental impact, customer satisfaction, and supply chain management.

Responsibilities include:

Lead Lean Six Sigma and Kaizen initiatives to enhance company performance and drive Continuous Improvement.

Conduct statistical analysis, product testing, and measurements to ensure superior quality.

Engage with customers to facilitate customer complaints, corrective actions, and preventative measures.

Assist in developing and delivering quality training programs for employees.

Evaluate suppliers and establish quality requirements to maintain high standards.

Support product development activities, ensuring quality considerations are integrated.

Maintain systems for external registrations such as ISO 13485 and generate quality-related metrics reports.

Qualifications:

3-5 years of Quality Engineering, ideally in a medical or healthcare facility.

Strong knowledge of quality systems, manufacturing systems, and ISO standards (including ISO 13485).

Extensive experience with Statistical Process Control (SPC), inspection systems, calibration systems, and design of experiments (DOE).

Ability to manage & supervise individuals and teams.

Solid experience with statistical software (Minitab and JMP).

Educational Background: BS in Engineering or equivalent combination of education, skills, and experience.

Six Sigma Black Belt certification: Obtain and maintain certification.

Preferred skills and experience:

Strong background in Medical Device Validation. IQ, OQ, PQ and report summary.

Experience with First Article, Modified First Article, DOE, and Capability Studies.

Risk Documentation including PFMEA and Risk Assessment

FDA Regulations, Risk Management, ISO 13485

CAPA, Root Cause Analysis, and Failure investigation.