Quality Manager

American Society for Quality; Clayton (NC); On-site; USD 110,000 - 138,000; Full time

Benefits offered by this job

Health coverage

Dental coverage

Vision coverage

401(k) plan

Job summary

TekniPlex in Clayton, NC is hiring a Quality Manager to oversee the site Quality Management System (QMS) and foster a strong quality culture. The role delivers consistent quality performance and mentors the QA team, aligning with customer and regulatory requirements including 21 CFR 820 and ISO 13485.

The position offers an annual salary range of $110,000 to $138,000, commensurate with experience, plus a comprehensive benefits program.

Qualifications

• Bachelor's degree in Engineering, Business with a strong quality focus, or similar degree.
• 10+ years of quality assurance management experience.
• Experience with FDA 21 CFR Part 820 and ISO 13485 environments is required.
• Strong understanding of statistics, quality equipment, instruments and processes.
• Excellent communication and interpersonal skills.
• Six Sigma Black Belt certification preferred.
• Exceptional attention to detail.
• Self-directed with leadership qualities.
• Ability to travel up to 15%.

Responsibilities

• Act as the site Management Representative for the QMS and ensure effectiveness per 13485:2016.
• Manage customer complaints, non-conforming material, CAPA implementation and follow-up.
• Develop, review, and approve QA documentation for site activities.
• Report QMS performance to top management and drive improvements.
• Build relationships with customers through proactive quality communication.
• Ensure manufacturing processes meet customer, FDA 21 CFR 820, and ISO 13485 requirements.
• Lead internal and external audits including notified body inspections.
• Lead and mentor a high-performing QA team aligned with business objectives.
• Promote a quality culture and continuous process improvements across the business.
• Manage the Quality budget with site management to achieve objectives.

Skills

QMS Leadership

Quality Assurance

Audit Leadership

CAPA Management

Regulatory Knowledge

Statistical Analysis

Communication

Education

Bachelor's degree in Engineering or Business

Tools

Statistical software

Job description

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.

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
• Prefer Six Sigma Black Belt certification
• Exceptional attention to detail
• Must be self-directed with leadership qualities
• Ability to travel up to 15%

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 effectively present information and respond to questions from 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 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.

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.

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

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.