Quality & Regulatory Manager

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
• Continuous Improvement
• PPAP/ Validations
• Inspection
• Engineering Technician
• 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
• 3 weeks PTO + 48hrs Sick
• Medical
• Dental
• Vision
• Short Term Disability/Long Term Disability
• Group Basic Life
• Voluntary Life Insurance
• Hospital/Accident/Critical Illness Coverage
• Pet Insurance
• Identity Theft and Legal Services Coverage
• 401k with company match
• Gym Membership Reimbursement
• Tobacco Cessation Reimbursement