Quality & Regulatory Manager

Quality Manager

Minneapolis Direct Hire $125000 to $140000

A growing quality-driven manufacturer is seeking an experienced Quality & Regulatory Manager to lead quality assurance regulatory compliance and continuous improvement initiatives at its Minnesota facility. This highly visible leadership position oversees the Quality Management System internal auditing product inspection validation activities supplier quality and the quality team.

The ideal candidate brings extensive quality leadership experience within plastic injection molding and regulated manufacturing environments. This position offers the opportunity to influence company-wide quality strategy strengthen ISO compliance support new product development and build a culture of accountability and continuous improvement.

Quality & Regulatory Manager Responsibilities

Oversee maintain and continuously improve the facilitys Quality Management System ensuring continued compliance with ISO 13485 ISO 9001 newly released ISO standards customer requirements and applicable regulatory requirements.

Lead the facilitys internal audit and document control programs ensuring quality documentation processes and records meet QMS ISO regulatory agency and customer-specific requirements.

Serve as the primary Quality Department contact for customers managing PPAPs first article inspections IQ/OQ/PQ validations customer complaints SCARs CARs customer audits product quality requirements and related corrective actions.

Manage all product inspection activities including incoming in-process final FAI PPAP and validation inspections while using company metrics visual management tools and quality KPIs to increase awareness and ensure required product quality levels are achieved.

Drive continuous improvement throughout the organization by identifying process and quality system improvements applying lean and statistical analysis techniques monitoring quality assurance trends and aligning industry best practices with customer quality expectations.

Partner with leadership engineering operations purchasing and other departments to define quality targets clarify customer requirements develop suppliers conduct supplier audits manage supplier performance ratings support DOE and product testing assist with new-project quoting and provide project management and new-product support.

Lead develop and evaluate Quality Assurance employees including interviewing hiring onboarding training work assignment performance appraisals recognition coaching and disciplinary activities in accordance with company policies and applicable laws.

Establish clear department goals performance expectations and accountability measures while creating a team-oriented culture that recognizes employee contributions and encourages participation in improving company performance.

Demonstrate and reinforce the organizations core values of customer focus execution teamwork and respect.

Quality & Regulatory Manager Qualifications

At least 15 years of experience within a manufacturing environment including 710 years of recent quality management experience preferably in a senior leadership capacity.

Five to ten years of experience supporting plastic injection molding operations with a strong working knowledge of injection molding processes.

In-depth experience managing Quality Management Systems within ISO 13485 and ISO 9001 environments including internal audits document control PPAP FAI IQ/OQ/PQ validations inspection programs corrective actions customer audits and supplier quality.

Demonstrated success implementing continuous improvement lean manufacturing quality initiatives good manufacturing practices and other process improvement methodologies.

Strategic and data-oriented leadership approach including experience using statistical analysis KPIs metrics and trend data to identify risks and improve quality performance.

Self-motivated leader who can make sound decisions appropriately delegate authority motivate others and build a collaborative team-oriented work environment.

Strong written and verbal communication skills with the ability to work effectively across leadership engineering operations purchasing customers suppliers and regulatory stakeholders.

Experience supporting engineering and new-product activities including design of experiments product testing project quoting project management and product launches.

Benefits

Three weeks PTO

Paid sick time

Medical insurance

Dental insurance

Vision insurance

Short-term and long-term disability coverage

Group basic life insurance

Voluntary life insurance

Hospital accident and critical illness coverage

Pet insurance

Identity theft and legal services coverage

401(k) plan with company match

Gym membership reimbursement

Tobacco cessation reimbursement

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Konik is an equal-opportunity employer. All qualified applicants will receive consideration for employment without regard to race religion color national origin sex sexual orientation gender identity age status as a protected veteran status as a qualified individual with a disability or any other protected class status.

Konik has been a leader in the technical staffing industry for more than 50 years providing the fastest and easiest link between employees and employers. Konik has specialized in placing professional qualified personnel in Minnesota and western Wisconsin businesses since its inception and maintains a strong commitment to customer service.

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Required Experience:

Manager