Senior Quality & Regulatory Leader – ISO & Injection Molding

Gilder Search Group; Minneapolis (MN); On-site; USD 125,000 - 140,000; Full time

Benefits offered by this job

Three weeks PTO

Medical insurance

Dental insurance

Vision insurance

Disability coverage (short/long-term)

Life insurance

Pet insurance

401(k) plan with company match

Gym membership reimbursement

Tobacco cessation reimbursement

Job summary

Gilder Search Group partners with a Minnesota manufacturer to recruit a Quality & Regulatory Manager for the Minneapolis facility. This senior role directs quality assurance, regulatory compliance, and continuous improvement across the site to ensure robust QA and ISO alignment.

The ideal candidate has extensive plastic injection molding quality leadership experience, strong audits and supplier quality background, and a strategic, cross-functional leadership style to drive quality initiatives

Qualifications

• 15+ years of manufacturing experience with 7–10 years in quality management, preferably in a senior leadership role.
• 5–10 years of plastic injection molding quality leadership experience.
• Deep experience building/managing Quality Management Systems (ISO 13485, ISO 9001) with internal audits, document control, PPAP/FAI, inspections, and supplier quality.
• Proven track record in continuous improvement, lean manufacturing, GMP practices, and data-driven quality initiatives.
• Strategic, data-driven leader with strong communication and cross-functional collaboration skills.

Responsibilities

• Oversee and continuously improve the facility's Quality Management System to ensure ISO and customer requirements compliance.
• Lead internal audits and document control, ensuring records meet QMS/ISO/regulatory standards.
• Serve as primary Quality contact for customers, managing PPAPs, inspections, validations, complaints, SCARs, CARs, and audits.
• Manage all product inspection activities (incoming, in-process, final, FAI, PPAP, validation) with metrics and KPIs.
• Drive continuous improvement using lean methods and statistical analysis to align with best practices and customer expectations.
• Partner with leadership, engineering, operations, purchasing to define quality targets and supplier development.
• Lead QA team, including hiring, training, performance management, and development.
• Set department goals and accountability, fostering a team-oriented culture and adherence to core values.

Skills

Quality leadership

Regulatory compliance

QMS leadership

Lean manufacturing

Statistical analysis

Cross-functional collaboration

Supplier management

Project management

Communication

Job description

Gilder Search Group partners with a Minnesota manufacturer to recruit a Quality & Regulatory Manager for the Minneapolis facility. This senior role directs quality assurance, regulatory compliance, and continuous improvement across the site to ensure robust QA and ISO alignment.

The ideal candidate has extensive plastic injection molding quality leadership experience, strong audits and supplier quality background, and a strategic, cross-functional leadership style to drive quality initiatives