Quality & Regulatory Manager

Company; Vadnais Heights, Northern (MN, KY); Hybrid; USD 120,000 - 140,000; Full time

Benefits offered by this job

Medical

Vision

Group Life Insurance

401k with company match

Pet Insurance

Job summary

Wright Engineered Plastics is seeking a senior Quality leader to oversee the Minnesota facility's Quality Management System and drive continuous improvement. You will lead internal audits, PPAP/validations, and supplier quality, ensuring alignment with ISO 13485 and ISO 9001 standards.

The role requires extensive experience in manufacturing, injection molding, and data-driven quality initiatives. Travel up to 20% and collaboration with leadership are essential.

Qualifications

• 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

Responsibilities

• Oversee, maintain and continuously improve the QMS at the Minnesota facility.
• Ensure the appropriate QMS is updated to comply with newly released ISO standards.
• Oversee and manage internal audit programs at the Minnesota facility in compliance with ISO 13485 standards.
• Drive continuous improvement strategies with focus on process improvements and the QMS.
• Support and maintain ISO standards.
• Ensure product quality levels meet company metrics and visuals.
• Interface with all departments to ensure customer requirements are understood and defined within the QMS.
• Manage document control to ensure compliance with customer document requirements, QMS, ISO, and regulatory needs.
• 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.
• Travel to other work sites: up to 20%.

Skills

Quality leadership

QMS

ISO 13485

ISO 9001

Lean/Continuous improvement

Injection molding

Data analysis

Tools

DOE

Statistical analysis

Job description

Willow Lake, 1185 Willow Lake Blvd., Vadnais Heights, Minnesota, United States of America

Job Description

Posted Thursday, June 18, 2026 at 4:00 AM

KEY ACCOUNTABILITIES: (The broad spectrum of items that the role is ultimately held accountable for at the end of the day. Results.)

• Quality Management Systems
• Internal Audits
• PPAP/ Validations
• Inspection
• Project Management

KEY RESPONSIBILITIES: (The finer details of what the role is assigned for the day-to-day activities on the job. Tasks to support results.)

• Oversee, maintain and continuously improve the QMS (Quality Management System) at the Minnesota facility.
• Ensure the appropriate QMS is updated to comply with newly released ISO standards.
• Oversee and manage internal audit programs at the Minnesota facility in compliance with ISO 13485 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

LMA RESPONSIBILITIES: (Leadership, Management, Accountability)

• Yes
• 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.

QUALITIES FOR SUCCESS: (Wright Engineered Plastics Core Values, Education, Training, Certifications, Years of experience, other skills and abilities, Physical Requirements for the Role, etc.)

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

Compensation and Benefits

• Up to $140,000
• Medical
• Vision
• Group Basic Life
• Voluntary Life Insurance
• Hospital/Accident/Critical Illness Coverage
• Pet Insurance
• Identity Theft and Legal Services Coverage
• 401k with company match

Willow Lake, 1185 Willow Lake Blvd., Vadnais Heights, Minnesota, United States of America