Quality/Compliance Lead

Job Description

Job Description

QUALITY SYSTEMS & COMPLIANCE LEAD

Industrial & Medical parts manufacturing · Northwest Indiana · Full-time, on-site

Why this seat exists
A Industrial & Medical parts manufacturer in Northwest Indiana is bringing its quality system work in-house. The audit function is currently supported outside the company. This is a new role, built so one person can own the quality management system, stand up the internal audit program, and make the documentation match how the plant actually runs. It is a process and procedure seat. It is not a parts-inspection job.

 

The plant makes composite parts for medical and industrial customers. Quality has to hold across both. The standards in play are ISO 9001 and ISO 13485, with ISO 14001 in the system as well. The person in this seat owns the electronic QMS, the document-control rules, the CAPA process, and the audit calendar. They turn a requirement into a procedure an operator or an engineer can follow, then they check that it is being followed.

The hiring manager wants a partner, not a coordinator who waits for a checklist. High energy, initiative, and a desire to build the system matter as much as the certificate. Daily direction is not the design of the job.

What you will own

 

• The quality management system. Effectiveness, not a binder. Governance inside the electronic QMS, including workflows, revision control, and the link to training.
• The internal audit program. Design it, run it, and close findings with an effectiveness check. This function is being brought in-house. You will build the program, not inherit a finished one.
• External audit leadership. Primary lead for ISO certification audits. Support for customer audits. Audit readiness is a standing condition, not a week before the registrar arrives.
• The document system. Own it. Refine what is already in use. Release, revision, and workflow inside the eQMS, and training assigned and finished before a change hits the floor.
• CAPA. Structured root cause, corrective action, closure timing, and a check that the action worked.
• The bridge to the floor. Translate ISO and regulatory requirements into processes Operations and Engineering will actually use. Standardize the system across medical and industrial work.

What “audit heavy” means here

 

• You have built or run an internal audit program, not only sat in on audits someone else scheduled.
• You have been the lead, or the clear number two, on an ISO certification audit. 9001 is required. 13485 is required. 14001, AS9100, or IATF 16949 is useful.
• You can show a procedure you wrote or rewrote because the old one did not match the floor, and you can say whether people followed it.
• You have owned document control as a system: revision, approval, training alignment. Not only filing.
• You have driven a CAPA to a verified close without a manager rewriting it.
• You influence people who do not report to you. Quality engineers, supervisors, operations, engineering.

Background

 

• Level. Several years in quality systems, quality engineering, or manufacturing quality, with real ownership of the system. Many strong fits will come from an ISO coordinator or quality systems role. Years on a page matter less than evidence you have built or run the audit program and the document system.
• Environment. Manufacturing, high-mix preferred. You understand how a quality system lands on a production floor. Composite or medical-device exposure is an advantage.
• Systems. Electronic QMS experience. 1factory is the platform in use. A similar eQMS is transferable if you have owned the workflows.
• Credentials. Bachelor's in engineering, quality, manufacturing, or a related field is preferred. ISO Lead Auditor, ASQ CQE, or CQA is a plus. A closed audit program is the better proof.

Who this is not for

 

Incoming inspectors, lab technicians, and quality engineers whose work is the part in front of them. This role does not own piece-part disposition as the main job. It also is not a pure document-control clerk seat. The hire has to create the audit program and refine the system that is already there, with mild coaching and a hiring manager who wants a partner.

Location
Northwest Indiana, on-site, in a small industrial community within commuting distance of the South Bend / Michiana area. Confidential search. Company name withheld on this posting.