Global MedTech Quality Leader: Build & Elevate QMS

Tekni-Plex, Inc.; Ridgefield (NJ); Hybrid; USD 117,000 - 150,000; Full time

Benefits offered by this job

Relocation assistance

Healthcare benefits

401(k)

Job summary

TekniPlex is hiring a Sr. Quality Manager for our Ridgefield, NJ location. The Sr.

Quality Manager has responsibility for Quality across multiple Manufacturing sites within the Tekni-Plex Medtech Solutions (MTS) business. They will work closely with site leadership to deliver consistent quality through an effective Quality Management System and foster a strong quality culture. Relocation assistance is available for qualified candidates; travel up to 25% may be required; role is on-site five days

Qualifications

• Bachelor’s degree with extensive quality assurance management experience in the Medical Device Industry.
• Experience with ISO 13485, ISO 14971 and FDA 21 CFR 820.
• Strong statistical and quality tools knowledge.
• Excellent communication and interpersonal skills.
• Self-directed with proven leadership qualities.

Responsibilities

• Lead the Quality Management System across multiple sites.
• Champion deployment of new Quality Initiatives and standardize processes.
• Partner with Manufacturing, Operations, Engineering, and Management.
• Plan and coordinate NPIs, test method validations, and product transfers.
• Direct process and product improvement programs adhering to best practices.
• Coach and develop Quality teams and manage performance.

Skills

Quality management

ISO 13485

FDA 21 CFR 820

Statistics

Leadership

Communication

Education

Bachelor’s degree in a related field

Job description

TekniPlex is hiring a Sr. Quality Manager for our Ridgefield, NJ location. The Sr.

Quality Manager has responsibility for Quality across multiple Manufacturing sites within the Tekni-Plex Medtech Solutions (MTS) business. They will work closely with site leadership to deliver consistent quality through an effective Quality Management System and foster a strong quality culture. Relocation assistance is available for qualified candidates; travel up to 25% may be required; role is on-site five days