Quality/Compliance Lead

Quality Systems & Compliance Lead

Location: Northwest Indiana
Job Type: Full-time

Description

General Job Description

The Quality Systems & Compliance Lead is responsible for owning and maintaining the effectiveness of the Quality Management System (QMS) within a hands-on manufacturing environment. This role ensures compliance with ISO 9001, ISO 13485, and ISO 14001 while driving the practical application of quality system requirements across medical and industrial manufacturing 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.

Duties & Responsibilities

• Own and maintain the organization’s Quality Management System (QMS) within an electronic QMS platform.
• 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 the 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 manufacturing operations.
• Ensure audit readiness across all departments and functions.

Education & Training

• Bachelor’s degree in Engineering, Quality, Manufacturing, or a related field preferred.
• Relevant certifications such as ISO Lead Auditor, ASQ CQE, or CQA preferred.

Knowledge & Experience

• 7 years of experience in Quality Systems, Quality Engineering, or Manufacturing Quality.
• Demonstrated experience in a manufacturing environment; high-mix manufacturing experience 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, including ISO and/or customer audits.
• Experience with electronic QMS systems; experience with 1factory or a similar platform preferred.

Skills & Abilities

• 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.

Working Conditions

The physical demands are representative of those that must be met by an associate to successfully perform the essential functions of the job. Reasonable accommodations may be made to perform the essential functions. While performing the duties of this job, associate is regularly required to sit, stand, stoop, climb, walk, use hands, talk, and hear for a minimum of eight (8) hours per shift

HOURS / SHIFTS

Varies depending on project and customer needs.