Sr Quality Manager

About the role

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.

Responsibilities

• Lead the Quality Management System and teams across multiple sites, ensuring compliance with Tekni-Plex Quality requirements and in line with 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 of 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 used to identify targeted continuous improvement initiatives.

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 statistics, quality equipment, instruments and processes related to Manufacturing.
• Good communication and interpersonal skills using tact and diplomacy.
• Prefer Six Sigma Black Belt/Green Belt certification.
• Exceptional attention to detail.
• Must be self-directed with proven leadership qualities.

Pay

The salary range for this role is $117,000 to $150,000 annually. Pay is based on experience. Relocation assistance is available for qualified candidates.

Benefits

• Medical Coverage
• Prescription Drug Coverage
• Telemedicine
• Dental Coverage
• Vision Coverage
• Employee Assistance Program
• Health Savings Account (HSA)
• Flexible Spending Account (FSA)
• Basic Term Life/AD&D Insurance
• Voluntary Life/AD&D Insurance
• Short Term Disability (STD)
• Long Term Disability (LTD)
• Voluntary Buy-Up LTD
• Hospital Indemnity
• Accident Insurance
• Critical Illness
• 401(k) Retirement Savings Plan
• Daily Pay
• Business Travel Insurance
• Legal Plan
• Identity Protection

Schedule

• 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.