Quality Manager

About the Role

TekniPlex is hiring a Quality Manager for our Madison, WI facility. As the appointed Management Representative for Quality, this position holds the Quality Authority for final disposition decisions of all materials and product. Reporting directly to the Quality Director with a dotted line to the Plant Manager, the Quality Manager is responsible for maintaining and continuously improving quality standards.

Responsibilities

• Manage the site’s Quality Management System using Intelex (eQMS software).
• Oversee complaint management, nonconformances, training management, document control, change management, supplier management, audit management, and calibration.
• Evaluate KPIs by completing monthly and annual KPIs and drive improvements to ensure compliance with site quality objectives.
• Ensure products meet internal and external quality requirements.
• Coordinate Corrective Action activities.
• Oversee selection and maintenance of tools, inspection systems, and associated equipment.
• Manage supplier quality, including supplier approval, complaints, and audits.
• Evaluate and review quality requirements and communicate with customers regarding complaints, change control, etc.
• Serve as ISO Management Representative; ensure QC participation/compliance with GMP and other programs.
• Participate in cross-site internal audits of other TekniPlex Healthcare locations.
• Plan, host, and coordinate Internal, Customer, and annual ISO 13485 audits.
• 5-10% travel for cross-site internal audits and/or supplier audits.
• Supervisory oversight of the quality team, including performance management.
• Participate in the facility’s Safety and Environmental programs to ensure a safe work environment.
• Promote worker safety by:
  • Actively assessing activities to ensure no unsafe actions or results occur.
  • Stressing safe working practices as a condition of employment.
  • Leading audit initiatives of employee behaviors to ensure compliance with safety rules and guidelines, as well as housekeeping audits.
  • Ensuring housekeeping in the facility is maintained or improved.
  • Ensuring all corporate safety initiatives are followed.
• Ensure quality products and processes are maintained by:
  • Understanding and supporting both quality policies and the Quality System.
  • Performing work to ensure quality meets or exceeds internal and external customer specifications.
  • Identifying and correcting quality issues throughout the plant.
  • Developing and implementing quality training.
  • Participating in system or quality-based training provided or recommended by the company.
• Actively participate in the continuous improvement process by:
  • Identifying and addressing opportunities to reduce cost, improve product repeatability, and reliability.
  • Leading or championing CI teams to eliminate problems and streamline operations.
• Perform all other duties as assigned.

Requirements

• BS in engineering, quality, or equivalent work experience.
• Minimum 5+ years as Quality Manager or other leadership experience in a manufacturing environment within a regulated industry, or equivalent combination of education and experience.
• Minimum 3 years of supervisory experience.
• Minimum 3 years of flexible packaging experience or equivalent preferred.
• Experience managing eQMS (e.g., Intelex) activities.
• Previous ISO and GMP experience required, preferably ISO 13485.
• Knowledge of FDA requirements (21 CFR).
• Medical device experience is a plus.
• Strong computer skills, including:
  • Microsoft products (Excel).
  • ERP and other planning software.
  • Minitab.
• Basic understanding of quality equipment, instruments, and processes.
• Strong communication and interpersonal skills (internal and external).
• Ability to develop and lead an accountable team.
• Strong negotiation and conflict resolution skills.
• Strong attention to detail.
• Self-motivated.

Skills

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, blueprints, and technical drawings (machine, mechanical, pneumatic, hydraulic, and electrical).
• Ability to effectively present information in one-on-one and small group situations.
• 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.

• Regularly required to stand, walk, and talk or hear.
• Frequently required to use hands to finger, handle, or feel and reach with hands and arms.
• Occasionally required to sit; climb or balance; stoop, kneel, crouch, or crawl; and taste or smell.
• Must regularly lift and/or move up to 10 pounds, frequently lift and/or move up to 50 pounds.
• Specific vision abilities required include close vision, distance vision, color vision, peripheral vision, depth perception, and ability to adjust focus.

Work Environment

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.

• Frequently 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.
• The noise level in the work environment is usually moderate.

Pay

The salary range for this role is $108,000 to $162,000 annually.

Benefits

TekniPlex provides a comprehensive and flexible benefits program that you can customize to fit your personal needs. Our programs offer health care coverage and financial security for you and your family.

• 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