Hands-On Quality & Regulatory Lead (ISO 13485)

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

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