Sr Quality Manager

TekniPlex•Madison, WI

22h•Onsite

About The Position

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.

Requirements

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.
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.
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.
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.

Nice To Haves

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.

Responsibilities

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.
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.
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.
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.
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.
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.