Sr Quality Manager

TekniPlex•Ridgefield, NJ

7d•$117,000 - $150,000•Onsite

About The Position

TekniPlex is hiring a Sr. Quality Manager for our Ridgefield, NJ location. The Sr. Quality Manager has responsibility for the Quality across multiple Manufacturing sites within the Tekni-Plex Medtech Solutions (MTS) business. They will work closely with site leadership teams to deliver consistent quality of performance through the management of an effective Quality Management System, promote a strong Quality culture within the business, and develop, through coaching and mentorship, the skills and experience of the Quality team.

Requirements

Bachelor’s degree with at least 12 years previous quality assurance management experience in the Medical Device Industry.
Must have experience with ISO 13485, ISO 14971 and FDA 21 CFR 820.
Strong understanding of statics, quality equipment, instruments and processes related to Manufacturing.
Good communication and interpersonal skills using tact and diplomacy.
Exceptional attention to detail.
Must be self-directed with proven leadership qualities.

Nice To Haves

Prefer Six Sigma Black Green/Belt certification.

Responsibilities

Lead the Quality Management System and teams across multiple sites, ensuring compliance with Tekni-Plex Quality requirements and in line ISO 13485, ISO 14971 and FDA 21 CFR 820.
Champion the deployment of new Quality Initiatives by establishing, standardizing, and monitoring processes designed to strengthen product and process quality.
Partner with Manufacturing, Technical Operations, Engineering, and Management to support site operations, technology transfers, qualifications, and validation activities.
Lead or support the planning, coordination of NPI validations, test method validations, product transfers and/or equipment qualification/requalification
Direct process and product improvement programs, ensuring adherence to excellence and embedding industry best practices throughout the organization.
Lead, coach, and develop the Quality teams through effective resource planning, performance management and talent development.
Promote a strong quality culture built on accountability, collaboration, continuous improvement and proactive risk management.
Partner with Manufacturing, and Engineering teams to resolve customer quality issues through robust root cause analysis and targeted corrective/preventive action implementation.
Coach and mentor teams in advanced quality tools and methodologies to support structured problem-solving techniques.
Manage the execution internal audits to maintain the effectiveness of the Quality Management System, support customer audits and notified body audits.
Promote and manage effective Quality reporting across the sites to ensure Quality performance is trended against objectives and use to identify targeted continuous improvement initiatives.
Up to 25% travel (both in-state and out-of-state); requires regular visits to each location.
Role must be on site 5 days a week – time spent between the sites will be dependent on immediate and project needs.
Travel to other Tekni-Plex sites as required to support business objectives.