Quality Manager

JOB SUMMARY

Tekni Plex is hiring a Quality Manager for our Clayton, NC facility. The Quality Manager works to deliver consistent quality of performance through the management of an effective Quality Management System, promotes a strong Quality culture within the business, and develops, through coaching and mentorship, the skills and experience of the Quality team. This position offers an annual salary range of $110,000 to $138,000, based on experience and qualifications.

• Acts as the Management representative for the site and is responsible for the overall effectiveness of the site QMS processes in line with the requirement of 13485:2016.
• Manage customer complaints process, non-conforming material process and CAPA (Corrective and Preventive Action) implementation, and associated follow-up activities.
• Develop, review, and approve QA documentation as related to general QA activities required within the site.
• Report on QMS performance to top management and recommend improvements based on trends and analysis of process performance.
• Develop strong customer relationships through professional, constructive, proactive communication on product, process and system quality requirements including change notifications and responsiveness to quality concerns.
• Ensure all manufacturing processes are verified or validated, monitored, and maintained in and maintained in line with customer requirements, FDA 21 CFR 820, ISO 13485, and other applicable regulations.
• Lead internal and external audit programs, including notified body inspections.
• Build, mentor, and lead a high-performing Quality team, support their professional development and ensure alignment within the team against business objectives.
• Champion a Quality culture of Customer focus, proactively identifying and implementing process improvements and quality best practices across the business.
• Manages the Quality budget and works with site management to deliver business objectives.

• Bachelor’s degree in Engineering, Business degree with a strong quality focus, or similar degree
• 10+ years of quality assurance management experience
• Experience working within FDA 21 CFR Part 820 and ISO 13485 regulated environments is required
• Strong understanding of statistics, quality equipment, instruments and processes
• Good communication and interpersonal skills using tact and diplomacy
• Prefer Six Sigma Black Belt certification
• Exceptional attention to detail
• Must be self-directed with leadership qualities
• Ability to travel up to 15%

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 effectively present information and respond to questions from groups of managers, clients, customers, and the general public.

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.

Ability to solve practical problems and deal with a variety of variables 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.

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…