JOB SUMMARY

TekniPlex is hiring a Quality Manager for our Madison, WI facility. The QA Manager is the appointed Management Representative for Quality with associated responsibilities and authority. This position has the Quality Authority for final disposition decisions of all materials and product. The Quality Manager reports directly to the Quality Director with a dotted line to the Plant Manager and has overall responsibility to make decisions and take action so that quality standards are maintained and continuously improved. The salary range for this role is $108,000 to $162,000 annually.

DUTIES AND RESPONSIBILITIES

• Manage site's Quality Management System using Intelex (eQMS software)
• Responsible for complaint management, nonconformances, training management, document control, change management, supplier management, audit management, calibration
• Evaluate KPIs by completing monthly and annual KPIs
• Drive improvements to ensure compliance to site's quality objectives
• Responsible for assuring products meet internal and external quality requirements
• Coordinate Corrective Action activities
• Selection and maintenance of tools, inspection systems, and associated equipment
• Responsible for oversight of supplier quality, including supplier approval, complaints, and audits.
• The evaluation and review of quality requirements
• Communication with customers regarding complaints, change control, etc.
• ISO Management Representative; Responsible for 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 (e.g., cross-site internal audits, supplier audits, etc.)
• Supervisory oversight of quality team including performance management
• Responsible for participating in the facility's Safety and Environmental programs to ensure a safe work environment.
• 5-10% Travel for cross-site internal audits and/or supplier audits
• Promote worker safety by:
  • Actively assesses activities on a constant basis to ensure no unsafe actions or results will occur.
  • Stressing safe working practices as a condition of employment to associates.
  • Leading audit initiatives of employee behaviors to ensure compliance with safety rules and guidelines, as well as housekeeping audits and surveys.
  • Ensuring the housekeeping in the facility is maintained or improved to the highest level possible.
  • Ensuring that all corporate initiatives are followed as appropriate
• Ensures Quality products and processes are maintained by:
  • Understanding and supporting both quality policies and the Quality System.
  • Performing work at a level that ensures quality of this position's work meets or exceeds internal and external customer specifications.
  • Identifying and correcting, where possible, any identified quality issues throughout the plant.
  • Development and implementation of quality training.
  • Participating in system or quality-based training provided or recommended by the company
• Actively participates in the continuous improvement process by:
  • Identifying and addressing any opportunities to reduce cost, improve product repeatability & reliability
  • Lead and or champion CI teams to eliminate problems, streamline operations or other areas as defined by management
• All other duties as assigned.

QUALIFICATIONS

• BS in engineering, quality, or equivalent work experiences
• 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:
  • 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)
• Must have the ability to develop and lead an accountable team
• Strong negotiation and conflict resolution skills
• Strong attention to detail
• Must be self-motivated

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

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 effective present information and respond to questions form 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 variable 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

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.