Quality & Regulatory Manager

Seaway Plastics; Hoffmans Corner, Willow Lake (MN, SD); On-site; USD 126,000 - 154,000; Full time

Benefits offered by this job

3 weeks PTO + 48hrs Sick

Medical

Dental

Vision

Short Term Disability/Long Term

Group Life Insurance

401k with company match

Gym Membership Reimbursement

Tobacco Cessation Reimbursement

Pet Insurance

Identity Theft and Legal Services

Job summary

Seaway Plastics seeks a hands-on Quality & Regulatory Manager to lead from the front at our Minnesota facility. The role demands ISO 13485 experience and strong skills in Cp/Cpk, DOE, validation documentation, root cause analysis and continuous improvement, with plastics injection molding experience a plus.

This working manager balances leadership with hands-on technical involvement, driving QMS, audits, and supplier quality while collaborating across departments to meet customer requirements

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
• Self-starter who can motivate others
• Leader who can decide but delegate when appropriate
• Strong written and oral communication skills
• Experience with ISO 13485 and ISO 9001
• Ability to develop a team oriented work environment
• Strong knowledge of injection molding processes
• Experience implementing continuous improvement/lean methods
• Statistical analysis to identify trends from data
• Travel to other sites up to 20% with personal vehicle

Responsibilities

• Oversee, maintain and continuously improve the QMS at the Minnesota facility.
• Update QMS to comply with newly released ISO standards.
• Oversee internal audit programs in ISO 13485 compliance.
• Drive continuous improvement focusing on process improvements and the QMS.
• Support and maintain ISO standards.
• Ensure customer quality requirements are met using metrics and visuals.
• Interface with all departments to define customer requirements within the QMS.
• Manage document control for customer, QMS, ISO and regulatory requirements.
• Manage quality department interface with customers for PPAPs, validations, complaints, SCARs, audits, and product quality requirements.
• Manage all product inspection activities (FAI, PPAP, Validation, In-Process, final inspection).
• Develop and manage quality KPIs.
• Support purchasing with supplier development and audits.
• Cultivate a culture recognizing employee contributions and improvement participation.
• Stay ahead of QA trends and align practices with customer needs.
• Collaborate with leadership to define quality targets and objectives.
• Support engineering activities—DOE, product testing, quotes for new projects.
• Provide project management and new product support as needed.

Skills

Quality management

Statistical analysis

Cp/Cpk

DOE

Validation documentation

Root cause analysis

Continuous improvement

Lean Six Sigma Green Belt

Tools

QMS systems

Job description

We’re looking for a hands-on Quality & Regulatory Manager who leads from the front. The ideal candidate brings medical device manufacturing and ISO 13485 experience, strong technical problem-solving and statistical skills, and the ability to work alongside the team to get things done. Experience with Cp/Cpk, DOE, validation documentation, root cause analysis, and continuous improvement is highly valued, with plastics injection molding experience a plus. Lean Six Sigma Green Belt or higher preferred. This is an excellent opportunity for a true “working manager” who enjoys balancing leadership with hands‑on technical involvement.

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