JOB SUMMARY

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. 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.

DUTIES AND 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.

QUALIFICATIONS

• 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.
• Prefer Six Sigma Black Green/Belt certification.
• Exceptional attention to detail.
• Must be self-directed with proven leadership qualities.

TekniPlex provides a comprehensive and flexible benefits program that you can customize to fit your personal needs. Our programs offer you and your family health care coverage and financial security. You can take advantage of life insurance, disability coverage and voluntary benefits for extra financial protection and peace of mind. Plus, our work-life benefits provide support and assistance whenever you need it.

Some of your benefits are paid in full by TekniPlex and some costs are shared between you and TekniPlex. Other benefits are made available to you at reasonable group rates.

• 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

LANGUAGE SKILLS

Ability to read and interpret documents such as safety rules, operating and maintenance instructions and procedure manuals. Ability to write routine reports and legibly complete time cards and work orders. Ability to read, analyze, and interpret technical procedures and read blueprints and technical drawings, such as machine, mechanical, pneumatic, hydraulic, and electrical. Ability to effectively present information in one-on-one and small groups situations to other employees of the organization. Ability to effective present information and respond to questions form groups of managers, clients, customers, and the general public.

MATHEMATICAL SKILLS

Ability to add, subtract, multiply and divide in all units of measure, using whole numbers, common fractions, and decimals. Ability to compute rate, ratio, and percent. Ability to apply concepts of basic algebra, geometry, fractions, percentages, ratios, and proportions to practical situations.

REASONING ABILITY

Ability to solve practical problems and deal with a variety of variable in situations where only limited standardization exists. Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form. Ability to define problems, collect data, establish facts, and draw valid conclusions. Ability to interpret an extensive variety of technical instructions in mathematical or diagram form.

PHYSICAL DEMANDS

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations will be made to enable individuals with disabilities to perform the essential functions.

While performing the duties of this job, the employee is regularly required to stand, walk, and talk or hear. The employee frequently is required to use hands to finger, handle, or feel and reach with hands and arms. The employee is occasionally required to sit; climb or balance; stoop, kneel, crouch, or crawl; and taste or smell. The employee must regularly lift and/or move up to 10 pounds, frequently lift and/or move up to 50 pounds. Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception, and ability to adjust focus.

WORK ENVIRONMENT

While performing the duties of this job, the employee is frequently exposed to moving mechanical parts and vibration. The employee is occasionally exposed to high, precarious places; fumes or airborne particles; toxic, flammable or caustic chemicals; outside weather conditions; and extreme heat. The noise level in the work environment is usually moderate

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations will be made to enable individuals with disabilities to perform the essential functions.