Quality & Regulatory Manager

Konik•Minneapolis, MN

10d•Onsite

About The Position

A growing, quality-driven manufacturer is seeking an experienced Quality & Regulatory Manager to lead quality assurance, regulatory compliance, and continuous improvement initiatives at its Minnesota facility. This highly visible leadership position oversees the Quality Management System, internal auditing, product inspection, validation activities, supplier quality, and the quality team. The ideal candidate brings extensive quality leadership experience within plastic injection molding and regulated manufacturing environments. This position offers the opportunity to influence company-wide quality strategy, strengthen ISO compliance, support new product development, and build a culture of accountability and continuous improvement.

Requirements

At least 15 years of experience within a manufacturing environment, including 7–10 years of recent quality management experience, preferably in a senior leadership capacity.
Five to ten years of experience supporting plastic injection molding operations, with a strong working knowledge of injection molding processes.
In-depth experience managing Quality Management Systems within ISO 13485 and ISO 9001 environments, including internal audits, document control, PPAP, FAI, IQ/OQ/PQ validations, inspection programs, corrective actions, customer audits, and supplier quality.
Demonstrated success implementing continuous improvement, lean manufacturing, quality initiatives, good manufacturing practices, and other process improvement methodologies.
Strategic and data-oriented leadership approach, including experience using statistical analysis, KPIs, metrics, and trend data to identify risks and improve quality performance.
Self-motivated leader who can make sound decisions, appropriately delegate authority, motivate others, and build a collaborative, team-oriented work environment.
Strong written and verbal communication skills with the ability to work effectively across leadership, engineering, operations, purchasing, customers, suppliers, and regulatory stakeholders.
Experience supporting engineering and new-product activities, including design of experiments, product testing, project quoting, project management, and product launches.

Responsibilities

Oversee, maintain, and continuously improve the facility’s Quality Management System, ensuring continued compliance with ISO 13485, ISO 9001, newly released ISO standards, customer requirements, and applicable regulatory requirements.
Lead the facility’s internal audit and document control programs, ensuring quality documentation, processes, and records meet QMS, ISO, regulatory agency, and customer-specific requirements.
Serve as the primary Quality Department contact for customers, managing PPAPs, first article inspections, IQ/OQ/PQ validations, customer complaints, SCARs, CARs, customer audits, product quality requirements, and related corrective actions.
Manage all product inspection activities, including incoming, in-process, final, FAI, PPAP, and validation inspections, while using company metrics, visual management tools, and quality KPIs to increase awareness and ensure required product quality levels are achieved.
Drive continuous improvement throughout the organization by identifying process and quality system improvements, applying lean and statistical analysis techniques, monitoring quality assurance trends, and aligning industry best practices with customer quality expectations.
Partner with leadership, engineering, operations, purchasing, and other departments to define quality targets, clarify customer requirements, develop suppliers, conduct supplier audits, manage supplier performance ratings, support DOE and product testing, assist with new-project quoting, and provide project management and new-product support.
Lead, develop, and evaluate Quality Assurance employees, including interviewing, hiring, onboarding, training, work assignment, performance appraisals, recognition, coaching, and disciplinary activities in accordance with company policies and applicable laws.
Establish clear department goals, performance expectations, and accountability measures while creating a team-oriented culture that recognizes employee contributions and encourages participation in improving company performance.
Demonstrate and reinforce the organization’s core values of customer focus, execution, teamwork, and respect.