Quality & Regulatory Manager

Seaway Plastics Engineering•Port Richey, FL

About The Position

The Quality & Regulatory Manager leads quality excellence, regulatory compliance, and continuous improvement at the Minnesota medical device manufacturing facility. This is a hands-on working-manager role, balancing leadership and supervision of the Quality Assurance team with direct technical involvement and collaboration with operations, engineering, customers, suppliers, and company leadership. The role is accountable for maintaining and improving the Quality Management System, supporting compliance with ISO standards and customer requirements, and achieving product quality and business objectives. The manager oversees quality systems, internal audits, document control, product inspection, customer quality interfaces, supplier development, quality metrics, and continuous-improvement efforts. The position also supports engineering activities, including design and execution of DOE, product testing, project management, and new-product support. Travel to other work sites may be required up to 20%.

Requirements

15 years of experience in a manufacturing environment.
7 to 10 years of recent Quality management experience.
In-depth experience with QMS systems, including ISO 13485 and ISO 9001.
Experience with good manufacturing practices and quality initiatives and programs.
Strong working knowledge of injection molding processes.
Demonstrated experience implementing continuous improvement, lean, or other process-improvement techniques.
Experience with statistical analysis and identifying trends through data.
Ability to motivate others, make decisions, and delegate decision-making when appropriate.
Good written and oral communication skills.
Ability to develop and maintain a team-oriented work environment.
Must have a personal vehicle and a valid driver's license for travel to other work sites.

Nice To Haves

Medical device manufacturing experience.
Plastic injection molding experience.
Experience in a senior leadership capacity.
Experience with Cp/Cpk, DOE, validation documentation, and root cause analysis.
Lean Six Sigma Green Belt or higher.

Responsibilities

Oversee, maintain, and continuously improve the Quality Management System at the Minnesota facility.
Ensure the QMS is updated to comply with newly released ISO standards and support and maintain ISO standards.
Oversee and manage internal audit programs in compliance with ISO 13485 standards.
Drive continuous-improvement strategies focused on process improvements and the QMS.
Use company metrics and visual tools to help ensure product quality levels and heighten employee awareness.
Work with all departments to ensure customer requirements are understood and defined within the QMS.
Oversee document control for compliance with customer document requirements, the QMS, ISO standards, and applicable regulatory requirements.
Manage the Quality Department’s customer interface for PPAPs, validations (IQ, OQ, PQ), complaints, SCARs, CARs, customer audits, and product quality requirements.
Manage product inspection activities, including FAI, PPAP, validation, in-process, and final inspection.
Develop and manage quality-related KPIs.
Support purchasing with supplier development, performance ratings, and supplier audits.
Promote a culture that recognizes employee contributions and encourages participation in improving company performance.
Stay informed about Quality Assurance trends and updates and align best practices with customer quality needs.
Collaborate with company leadership to define quality targets and meet objectives.
Support engineering activities, including designing and performing DOE, product testing, quoting for new projects, project management, and new-product support.
Direct, coordinate, evaluate, and supervise Quality Assurance employees.
Interview, hire, train, appraise, reward, and discipline employees; plan, assign, and direct work in accordance with organizational policies and applicable laws.
Meet company goals and metrics and delegate decision-making when appropriate.