Quality Manager

Job Summary

TekniPlex 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.

Essential Duties And Responsibilities

• 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

Qualifications

• Bachelor’s degree in engineering, Business 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
• Prefers Six Sigma Black Belt certification
• Exceptional attention to detail
• Must be self-directed with leadership qualities
• Able to travel up to 15%

Reasoning Abilities

• Solve practical problems and deal with a variety of variable in situations where only limited standardization exists
• Interpret a variety of instructions furnished in written, oral, diagram, or schedule form
• Define problems, collect data, establish facts, and draw valid conclusions
• Interpret an extensive variety of technical instructions in mathematical or diagram form

Physical Demands

• While performing the duties of this job, the employee is frequently 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

Work Environment

• Frequent exposure to moving mechanical parts and vibration
• Occasional exposure to high, precarious places; fumes or airborne particles; toxic, flammable or caustic chemicals; outside weather conditions; and extreme heat
• Noise level in the work environment is usually moderate

Benefits

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.

Reasoning Abilities

• Read and interpret documents such as safety rules, operating and maintenance instructions and procedure manuals
• Write routine reports and legibly complete time cards and work orders
• Read, analyze, and interpret technical procedures and read blueprints and technical drawings, such as machine, mechanical, pneumatic, hydraulic, and electrical
• Present information in one-on-one and small groups situations to other employees of the organization
• Present information and respond to questions from groups of managers, clients, customers, and the general public
• Add, subtract, multiply and divide in all units of measure, using whole numbers, common fractions, and decimals
• Compute rate, ratio, and percent
• Apply concepts of basic algebra, geometry, fractions, percentages, ratios, and proportions to practical situations

Equal Opportunity

TekniPlex is proud to be an Equal Opportunity Employer. Our hiring practices provide equal opportunity for employment without regard to race, religion, color, sex, gender, national origin, age, United States military veteran’s status, ancestry, sexual orientation, marital status, family structure, medical condition including genetic characteristics or information, veteran status, or mental or physical disability so long as the essential functions of the job can be performed with or without reasonable accommodation, or any other protected category under federal, state, or local law.