Senior Quality & Regulatory Leader - Injection Molding

Konik; Minneapolis (MN); On-site; USD 125,000 - 140,000; Full time

Benefits offered by this job

Three weeks PTO

Paid sick time

Medical insurance

Dental insurance

Vision insurance

Short-term and long-term disability

Group life insurance

Voluntary life insurance

Hospital/accident/critical illness

Pet insurance

Identity theft and legal services

Job summary

Konik, based in Minneapolis, MN, is seeking a Quality & Regulatory Manager to lead quality assurance, regulatory compliance, and continuous improvement at its Minnesota facility. The role oversees the Quality Management System, internal audits, product inspection, validation activities, supplier quality, and the quality team.

The ideal candidate brings extensive leadership experience in plastic injection molding and regulated manufacturing environments, with a focus on ISO compliance, new

Qualifications

• 15+ years in manufacturing with 7–10+ years in quality leadership.
• Experience supporting plastic injection molding operations preferred.
• Deep experience with ISO 13485 and ISO 9001 quality systems.

Responsibilities

• Oversee and continuously improve the Quality Management System (QMS).
• Lead internal audits, document control, and regulatory compliance.
• Manage PPAPs, first article inspections, IQ/OQ/PQ validations, and supplier quality.
• Direct product inspection programs (incoming, in-process, final, validation).
• Drive Lean and continuous improvement using KPIs and data analysis.
• Collaborate with leadership to set quality targets and supplier development.

Skills

Quality Leadership

Regulatory Compliance

Audits & QA

QMS Management

Supplier Quality

KPIs & Analytics

Leadership & People

Communication

Job description

Konik, based in Minneapolis, MN, is seeking a Quality & Regulatory Manager to lead quality assurance, regulatory compliance, and continuous improvement at its Minnesota facility. The role oversees the Quality Management System, internal audits, product inspection, validation activities, supplier quality, and the quality team.

The ideal candidate brings extensive leadership experience in plastic injection molding and regulated manufacturing environments, with a focus on ISO compliance, new