Sr Quality Manager

TekniPlex•Ridgefield, NJ

2d•$150,000 - $180,000•Onsite

About The Position

TekniPlex is hiring a Sr. Quality Manager for its Ridgefield, New Jersey location. The position is responsible for quality across multiple manufacturing sites within the Tekni-Plex Medtech Solutions business. The manager works with site leadership to deliver consistent quality performance through an effective Quality Management System, strengthen the business’s quality culture, and develop the Quality team through coaching and mentorship. The role is on site five days per week, with time split between sites according to immediate and project needs. It involves up to 25% in-state and out-of-state travel, including regular visits to each location and travel to other Tekni-Plex sites as required. The annual salary range is $150,000 to $180,000, based on experience. Relocation assistance is available for qualified candidates.

Requirements

Bachelor’s degree.
At least 12 years of previous quality assurance management experience in the medical device industry.
Experience with ISO 13485, ISO 14971, and FDA 21 CFR 820.
Strong understanding of statistics, quality equipment, instruments, and processes related to manufacturing.
Good communication and interpersonal skills, using tact and diplomacy.
Exceptional attention to detail.
Self-directed, with proven leadership qualities.

Nice To Haves

Six Sigma Black Belt or Green Belt certification.

Responsibilities

Lead the Quality Management System and teams across multiple sites, ensuring compliance with Tekni-Plex Quality requirements, ISO 13485, ISO 14971, and FDA 21 CFR 820.
Champion new Quality Initiatives by establishing, standardizing, and monitoring processes 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 planning and coordination of NPI validations, test method validations, product transfers, and equipment qualification or requalification.
Direct process and product improvement programs, ensuring adherence to excellence and embedding industry best practices throughout the organization.
Lead, coach, and develop Quality teams through resource planning, performance management, and talent development.
Promote a quality culture built on accountability, collaboration, continuous improvement, and proactive risk management.
Partner with Manufacturing and Engineering teams to resolve customer quality issues through root cause analysis and corrective and preventive actions.
Coach and mentor teams in advanced quality tools and methodologies for structured problem-solving.
Manage internal audits and support customer and notified body audits to maintain the effectiveness of the Quality Management System.
Manage quality reporting across sites, trend performance against objectives, and use results to identify targeted continuous improvement initiatives.
Travel up to 25%, regularly visiting each location and other Tekni-Plex sites as required.