Quality Systems Lead – ISO/AS9100, CAPA & Compliance

Lake Air Metals

New Hope, Northern (MN, KY)

Hybrid

USD 110,000 - 150,000

Full time

14 days+

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Benefits offered by this job

Competitive Pay

Full Benefits

401(k) Employer Match

PTO & Holidays

Tuition Reimbursement

Job summary

Lake Air Products seeks a seasoned Quality Systems Manager to own and improve the QMS across ISO 9001, ISO 13485, AS9100 and customer requirements. You will lead internal audits, manage CAPA activities, and partner with cross-functional teams to close gaps and enhance process effectiveness.

You will drive certification readiness, oversee documentation control, and develop training to strengthen quality culture while ensuring regulatory compliance and continual improvement within a manufacturing

Qualifications

10+ years of progressive quality management experience in manufacturing.
3+ years in a custom metals fabrication or contract manufacturing environment preferred.
Ability to lead, develop, and manage a quality team.
Experience analyzing quality metrics, operational data, budgets to inform decisions.
Bachelor’s degree or equivalent in a related field; professional certification is a plus.

Responsibilities

Own and improve the QMS to ensure compliance with ISO 9001, ISO 13485, AS9100 and customer requirements.
Lead internal audits and coordinate certifications and surveillance audits.
Manage CAPA processes and verify effectiveness of actions.
Drive risk-based thinking and risk management across the QMS.
Develop training programs to strengthen quality awareness and competency.
Maintain QMS documentation, records, and management reviews.