Quality Systems & Compliance Lead

Polygon Company•Walkerton, IN

3d•Onsite

About The Position

The Quality Systems & Compliance Lead is responsible for owning and maintaining the effectiveness of Polygon’s Quality Management System (QMS) within a hands-on manufacturing environment. This role ensures compliance to ISO 9001, ISO 13485, and ISO 14001 while driving practical application of quality system requirements across both Medical and Industrial operations. This position bridges compliance and manufacturing by translating regulatory requirements into effective, usable processes on the production floor. The role leads internal and external audit activities, drives system-level improvements, and ensures consistency across the organization. This is a senior individual contributor role with significant cross-functional influence.

Requirements

Bachelor’s degree in engineering, Quality, Manufacturing, or related field preferred
Relevant certifications (e.g., ISO Lead Auditor, ASQ CQE, CQA) preferred
7+ years of experience in Quality Systems, Quality Engineering, or Manufacturing Quality
Demonstrated experience in a manufacturing environment (high-mix preferred)
Strong understanding of how quality systems are applied in production settings
Experience working with one or more of the following standards: ISO 9001 (required), ISO 13485 (required), ISO 14001 (preferred), AS9100 or IATF 16949 (preferred)
Experience developing or managing internal audit programs
Experience leading external audits (ISO and/or customer audits)
Experience with electronic QMS systems (1factory or similar preferred)
Strong ability to translate regulatory requirements into practical manufacturing processes
Effective root cause analysis and problem-solving skills
Strong organizational and project management skills
Ability to work independently and drive initiatives without direct supervision
Excellent communication and cross-functional collaboration skills
Ability to influence without direct authority
Strong attention to detail with a systems-level mindset

Nice To Haves

Bachelor’s degree in engineering, Quality, Manufacturing, or related field
Relevant certifications (e.g., ISO Lead Auditor, ASQ CQE, CQA)
ISO 14001 experience
AS9100 or IATF 16949 experience
Experience with electronic QMS systems (1factory or similar)

Responsibilities

Own and maintain the company’s Quality Management System (QMS) within the electronic QMS platform (1factory)
Ensure compliance with ISO 9001, ISO 13485, and ISO 14001 requirements
Develop, implement, and maintain the internal audit program
Conduct internal audits and ensure timely closure and effectiveness of findings
Serve as primary lead for ISO certification audits and support customer audits
Translate ISO and regulatory requirements into practical, executable manufacturing processes
Identify gaps in processes and drive system-level improvements
Own and maintain the CAPA process, ensuring structured root cause analysis and effective corrective actions
Monitor CAPA performance, including closure timelines and effectiveness verification
Own document control system governance, including workflows, revision control, and training alignment
Execute or directly support document control activities as needed, including document release, revision, and workflow management within the eQMS.
Ensure training is assigned, tracked, and completed in alignment with document changes prior to implementation.
Partner with Operations and Engineering to ensure quality processes are aligned with real manufacturing practices
Provide guidance and support to cross-functional teams on document creation, formatting, and compliance expectations.
Support Quality Engineers and Supervisors with system-related guidance and best practices
Standardize quality system processes across Medical and Industrial divisions
Ensure audit readiness across all departments and functions