Quality Manager

Description Permanent position for a QA manager to lead integrated Quality Management System (QMS) in a high-mix, high-complexity manufacturing environment serving regulated medical device and aerospace markets.

Primary responsibilities will include:

. Serve as the QMS Management Representative, owning compliance with ISO 13485 and AS9100 requirements. Lead Management Reviews, quality planning, KPI alignment, and continuous improvement initiatives. Maintain robust Document Control and Change Control (ECO/ECN) processes. Lead third-party certification audits, customer audits, and regulatory inspections. Maintain compliance with

FDA 21 CFR

820, AS9100, and customer-specific quality clauses. Oversee CAPA, nonconformance (NCR), and complaint handling.

Integrate quality into NPI lifecycle:

phase-gate reviews and risk management. Establish First Article Inspection (FAI) and

PPAP/APQP.

Champion Statistical Process Control (SPC), MSA/Gage R&R, and data-driven problem solving. Manage Supplier Quality system.

Develop a high-performing quality team:

recruiting, coaching, training, succession planning. Requirements BS in engineering or other technical field. Strong experience in development and improvement of QMS for ISO 13485 and/or

AS9100 QA

audit leadership experience. Experience in developing a high-performing quality team: recruiting, coaching, training, succession planning. Hands on experience with CAPA, risk management, FAI (AS9100), validation (IQ/OQ/PQ), and SPC/MSA. Experience in QA management in the medical device and/or aerospace/defense industry. #ERGx