Quality & Regulatory Manager

Seaway Plastics•Vadnais Heights, MN

1d•$140,000 - $140,000•Onsite

About The Position

The Quality & Regulatory Manager will be responsible for overseeing, maintaining, and continuously improving the Quality Management System (QMS) at the Santa Rosa facility. This role ensures compliance with ISO standards, manages internal audit programs, drives continuous improvement, and interfaces with customers on quality-related matters. The manager will also oversee product inspection activities, develop quality KPIs, support supplier development, and foster a culture of quality and employee engagement. Additionally, the role involves supporting engineering activities, project management, and leading the Quality Assurance team.

Requirements

15 years’ experience in a manufacturing environment
7 to 10 years’ recent Quality management experience, preferably in a senior leadership capacity
5 to 10 years’ experience in plastic injection molding experience
Self-starter with the ability to motivate others.
Leader who is able to make decisions, but also comfortable delegating decision making when appropriate.
Good written and oral communication skills.
Experienced in good manufacturing practices and quality initiatives and programs.
In-depth experience with QMS systems including ISO 13485 and ISO 9001.
Ability to develop and maintain a team oriented work environment.
Strong working knowledge of injection molding processes.
Demonstrated experience at implementing continuous improvement, lean or other process improvement techniques.
Strategic thinker with experience in statistical analysis and identifying trends through data
Travel to other work sites: up to 20% (Must have a personal vehicle with valid driver license)

Nice To Haves

Demonstrates Wright Engineered Plastics Core Values
We are customer focused
We execute
We win together
We are respectful

Responsibilities

Oversee, maintain and continuously improve the QMS at the Santa Rosa facility.
Ensure the appropriate QMS is updated to comply with newly released ISO standards.
Oversee and manage internal audit programs at Santa Rosa facility in compliance with ISO 13485 and IATF 16949 standards.
Drive continuous improvement strategies with focus on process improvements and the QMS.
Support and maintain ISO standards.
Ensure that organizational product quality levels are met utilizing company metrics and visuals to heighten employee awareness downstream.
Interface with all departments to ensure customer requirements are understood and properly defined within the QMS.
Oversee document control to ensure compliance with customer document requirements, QMS, ISO, and applicable regulatory agency requirements.
Manage Quality Department interface with our customers related to all customer requirements; such as, PPAP’s, Validations (IQ, OQ, PQ), complaints, SCAR’s, CAR’s, Customer Audits, and product quality requirements.
Manage all product inspection activities, FAI, PPAP, Validation, In-Process, and final inspection.
Develop and manage all quality related KPI’s.
Support purchasing with supplier development, performance ratings and supplier audits.
Develop and maintain a culture that recognizes employee contributions and encourages participation in improving the performance and success of the company.
Understands and proactively keeps on top of Quality Assurance trends, updates, and aligning best practices to customer quality needs.
Collaborate with company leadership team to define Quality related targets and meet objectives.
Support Engineering Activities – Designing and Performing DOE, Product Testing, Quoting for New projects.
Project Management and new product support as needed.
Responsible for the overall direction, coordination, performance and evaluation of all quality assurance employees.
Responsible for the supervisory activities in accordance with the organization’s policies and applicable laws.
Responsibilities include meeting company goals and metrics, interviewing, hiring, and training employees; planning, assigning, and directing work; appraisals, rewarding and disciplining employees.