Quality Manager

Woodway USA•Waukesha, WI

11d

About The Position

We are seeking a highly dynamic and forward-thinking Quality Manager to provide oversight of quality systems across multiple manufacturing companies. With 3 companies (Woodway USA, Filtration Systems Inc, and Fluid Power Energy) in 2 facilities, located in Waukesha WI., the Quality Manager will establish benchmarks that reflect customer expectations, meet regulatory demands, and reinforce the company's dedication to excellence. About the Role: The person in this role is responsible for the execution and ongoing refinement of the QMS and compliance to ISO 13485 and 9001. Works in close partnership with management to align quality strategies with business objectives and regulatory compliance across all companies.

Requirements

Bachelor’s degree in engineering, quality management or equivalent.
Typically requires a minimum of 10 years of leadership experience in quality management and continuous improvement initiatives.
Experience driving organizational quality changes/improvements throughout multiple businesses and across functional areas.
Proven ability to identify challenges, develop innovative solutions, and implement them effectively.
Comprehensive understanding of quality management systems (QMS), including ISO standards (e.g., ISO 9001, ISO 13485) and industry-specific regulations (e.g., FDA, GMP).
In-depth knowledge of continuous improvement methodologies, such as Lean, Six Sigma, and Total Quality Management (TQM).
Expertise in new product development processes and integrating quality assurance throughout the product lifecycle.
Advanced knowledge of global regulatory requirements and compliance standards across multiple regions.
Strong understanding of risk management principles and strategies for mitigating quality-related risks.
Expertise in managing complex, multi-stakeholder projects with competing priorities.
Exceptional verbal and written communication skills to effectively collaborate with internal teams, external partners, and regulatory bodies.
Proficiency in using the Microsoft Office Suite including Word, Excel, and PowerPoint.

Responsibilities

Ensures compliance with industry regulations and customer requirements.
Leads initiatives to ensure conformance to internal and external quality standards across all manufacturing facilities and supply chains.
Oversees, implements, and maintains robust quality management systems (QMS) and continuous improvement methodologies to enhance process quality.
Oversees quality assurance processes in manufacturing operations to ensure products meet company standards and regulatory requirements.
Ensures supplier quality standards are met and maintained, fostering strong relationships with suppliers to drive continuous improvement.
Monitors and improves field quality, ensuring customer feedback is incorporated into processes and consistently exceeding customer expectations.
Partners with engineering to integrate quality assurance processes into new product development.
Drives continuous improvement initiatives in quality processes and practices. Leads the identification, prioritization, and execution of quality improvement projects across the organization to improve operational efficiency, product reliability, and customer satisfaction.
Leads the identification of potential risks related to product quality, safety, and compliance, and develops strategies for risk mitigation.
Acts as the voice of the customer, ensuring feedback is incorporated into processes and consistently exceeding customer quality expectations.
Leads internal/external quality audits and effectively managing any findings or corrective actions.
Establishes and tracks key performance indicators (KPIs) to measure quality outcomes, operational performance, and strategic alignment.
Performs other duties as assigned.
Performs human resources responsibilities for staff, which includes but is not limited to the following: hiring and terminating employees, promotions/pay adjustments, staff development, performance evaluations, resolution of employee concerns, and disciplinary counseling.
Develops and approves departmental policies, procedures, and guidelines to meet business needs.