JOB SUMMARY

The Senior Quality Manager provides strategic leadership for the Quality Management System (QMS) across the Madison Barrier Protection Systems manufacturing sites. This role is responsible for the development, implementation, and continuous improvement of quality system processes that ensure compliance with applicable regulatory requirements, customer expectations, and TekniPlex quality standards.

Working collaboratively with the site Quality Managers, Operations, Technical, and Commercial, this position establishes quality system strategy, drives systemic improvement, oversees customer quality relationships, and ensures quality issues are effectively investigated, corrected, and prevented.

The Senior Quality Manager leads a team consisting of two Site Quality Managers and two Quality Systems Specialists while fostering a culture of compliance, operational excellence, customer focus, and continuous improvement.

Essential Job Duties:

• Quality Management System Leadership
  • Provide strategic leadership for the Quality Management System across multiple manufacturing locations.
  • Develop, standardize, implement, and continuously improve quality system processes to drive consistency and operational excellence.
  • Ensure the QMS remains compliant with ISO 13485, applicable customer requirements, and internal corporate standards.
  • Lead Management Review activities by analyzing quality system performance and recommending strategic improvements.
  • Identify opportunities to simplify and improve quality processes while maintaining compliance.
• Quality Performance & Continuous Improvement
  • Establish and monitor key quality metrics and leading indicators.
  • Analyze trends in complaints, nonconformances, CAPAs, audits, supplier performance, process capability, and other quality data.
  • Ensure quality trends are proactively addressed before developing into systemic issues.
  • Drive cross-functional root cause investigations for significant quality events.
  • Monitor effectiveness of corrective and preventive actions across both sites.
  • Champion continuous improvement initiatives that improve quality performance and customer satisfaction.
• Customer Quality Leadership
  • Serve as the primary quality representative for strategic customer relationships.
  • Lead customer quality meetings, business reviews, complaint discussions, and escalated issue resolution.
  • Ensure customer complaints are investigated thoroughly, communicated professionally, and resolved in a timely manner.
  • Support customer audits and quality agreement negotiations as required.
  • Build strong customer confidence through transparent communication and effective issue management.
• Leadership & People Management
  • Directly supervise:
    • Two Site Quality Managers
    • Two Quality Systems Specialists
  • Provide coaching, mentoring, and professional development for quality personnel.
  • Define departmental priorities and allocate resources across multiple sites.
  • Foster collaboration and consistency between manufacturing locations.
  • Promote a culture of accountability, ownership, and continuous improvement.
• Cross-Functional Leadership
  • Partner closely with Operations, Engineering, Supply Chain, Technical Services, Commercial, and Corporate Quality.
  • Provide quality leadership for new product introductions, process changes, equipment qualifications, and technology transfers.
  • Ensure quality considerations are incorporated into business decisions and strategic initiatives.
  • Lead quality support for significant site projects and organizational initiatives.
• Compliance & Risk Management
  • Ensure effective internal audit, CAPA, document control, complaint handling, and training processes are maintained.
  • Oversee Quality Systems Specialists responsible for document control, training administration, complaint management, and special projects.
  • Monitor regulatory and customer requirements and implement changes within the QMS.
  • Support external audits by customers, certification bodies, and regulatory agencies.
  • Ensure timely and effective closure of audit findings and compliance actions.

QUALIFICATIONS

• Bachelor's degree in Engineering, Quality, Life Sciences, Packaging, Food Science, or related technical discipline.
• 8+ years of progressive quality leadership experience in a regulated manufacturing environment.
• 3+ years of leadership experience managing technical or quality professionals.
• Extensive knowledge of Quality Management Systems.
• Strong working knowledge of ISO 13485 and risk-based quality principles.
• Demonstrated expertise in root cause analysis, CAPA, complaint investigations, auditing, and continuous improvement.
• Excellent communication, organizational, and leadership skills.

• Preferred
  • ASQ Certified Quality Manager (CMQ/OE), Certified Quality Engineer (CQE), or Certified Quality Auditor (CQA).
  • Experience within medical device, pharmaceutical, healthcare packaging, or other highly regulated manufacturing environments.
  • Experience leading multiple manufacturing locations.
  • Experience managing customer quality relationships and supporting customer audits.
  • Lean Six Sigma Green Belt or Black Belt certification.

Knowledge, Skills & Abilities:

• Strategic thinker capable of balancing compliance with business objectives.
• Strong understanding of process improvement methodologies.
• Excellent problem-solving and decision-making abilities.
• Ability to influence without direct authority across multiple functions.
• Effective communicator with executive leadership, customers, and production teams.
• Strong analytical skills with the ability to interpret quality data and identify emerging risks.
• Skilled in leading change and driving organizational alignment.
• Ability to manage multiple priorities in a fast-paced manufacturing environment.

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.