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. This position offers an annual salary range of $110,000 to $138,000, based on experience and qualifications. Relocation assistance is available for qualified candidates.

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 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
• 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

• Frequently stand, walk, and talk or hear
• Frequently use hands to finger, handle, or feel and reach with hands and arms
• Sometimes sit; climb or balance; stoop, kneel, crouch, or crawl
• Occasionally taste or smell
• Regularly lift and/or move up to 10 pounds, frequently lift and/or move up to 50 pounds
• Regularly exposed to moving mechanical parts and vibration
• Occasionally exposed to high, precarious places; fumes or airborne particles; toxic, flammable or caustic chemicals; outside weather conditions; and extreme heat
• Work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job

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
• Work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job

Equal Opportunity Company

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.