Quality & Regulatory Manager

Seaway Plastics•Port Richey, FL

About The Position

Wright Engineered Plastics is seeking a hands-on Quality & Regulatory Manager to lead quality excellence, regulatory compliance, and continuous improvement at its Minnesota medical device manufacturing facility. This working-manager role combines leadership and supervision of the Quality Assurance team with direct technical involvement in quality systems, problem-solving, engineering support, and production-floor improvement. The manager will partner with operations, other departments, customers, suppliers, and company leadership to meet customer requirements and quality and business objectives. The role oversees and continuously improves the facility’s Quality Management System, maintains compliance with ISO 13485 and other applicable requirements, and manages audit, document-control, inspection, validation, customer-quality, and supplier-quality activities. It also supports engineering and new-product work, including design and performance of DOE, product testing, quoting, and project management. 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, preferably in a senior leadership capacity.
Experience with ISO 13485 is required.
In-depth experience with QMS systems, including ISO 13485 and ISO 9001.
Good manufacturing practices and quality initiatives and programs experience.
Strong working knowledge of injection molding processes.
Demonstrated experience implementing continuous improvement, Lean, or other process-improvement techniques.
Strong technical problem-solving and statistical skills, including experience with statistical analysis and identifying trends through data.
Ability to develop and maintain a team-oriented work environment.
Ability to motivate others, make decisions, and delegate decision-making when appropriate.
Good written and oral communication skills.
Must have a personal vehicle and a valid driver license for travel to other work sites.
Demonstrates Wright Engineered Plastics Core Values: customer focused, execute, win together, and respectful.

Nice To Haves

Medical device manufacturing experience.
5 to 10 years of experience in plastic injection molding.
Plastics injection molding experience.
Experience with Cp/Cpk, DOE, validation documentation, root cause analysis, and continuous improvement.
Lean Six Sigma Green Belt or higher.
Experience with CAPA management and implementing sustainable corrective actions.

Responsibilities

Oversee, maintain, and continuously improve the Quality Management System at the Minnesota facility.
Update the QMS to comply with newly released ISO standards and support and maintain ISO standards.
Oversee and manage internal audit programs at the Minnesota facility in compliance with ISO 13485.
Drive continuous-improvement strategies focused on process improvements and the QMS.
Use company metrics and visuals to help ensure product quality levels are met and increase employee awareness of downstream quality.
Work with all departments to ensure customer requirements are understood and appropriately defined within the QMS.
Oversee document control for compliance with customer document requirements, the QMS, ISO standards, and applicable regulatory agency requirements.
Manage the Quality Department’s customer interface on PPAPs, IQ/OQ/PQ validations, 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.
Foster a culture that recognizes employee contributions and encourages participation in improving company performance and success.
Keep current on 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, and quoting for new projects.
Provide project management and new-product support as needed.
Direct, coordinate, evaluate, and oversee the performance of Quality Assurance employees.
Conduct supervisory activities in accordance with organizational policies and applicable laws, including interviewing, hiring, training, planning and assigning work, directing work, conducting appraisals, and rewarding or disciplining employees.
Meet company goals and metrics.
Travel to other work sites up to 20%.