Quality Manager

Freudenberg Group • Beverly, MA

26d • Onsite

About The Position

Responsible for leading, development, and management of effective and compliant quality systems. This role works closely with various cross-functional members of the site to ensure all requirements are described and meet the needs of regulations and functional excellence. The Quality Manager serves as the Management Representative, responsible for representing the site to all regulatory bodies, including registered notified bodies, and ensuring management review activities are conducted per regulations. This position manages all client quality systems audits and ensures timely responses to any audit concerns. The Quality Manager acts as the primary contact for customers regarding quality-related issues/activities and ensures all field complaints are responded to per regulatory requirements. The role participates in strategic planning activities to ensure that all quality-related requirements are considered when establishing strategic goals and objectives, and participates in new product/project development to ensure quality requirements are established. The Quality Manager works directly with operating entities to ensure that management controls, product life cycle requirements including risk management, inspections, yield and product quality improvement, statistical process control analyses, and audits are conducted on a continuing basis as specified to enforce requirements and meet specifications. This role ensures that all site quality performance indicators (QPI) metrics presented to management are in sync with site and global requirements and metrics. The Quality Manager participates in and supports lean/continuous improvement initiatives and safety initiatives. This role ensures that quality activities are planned, resources are allocated, priorities are established, and activities are executed to meet goals. Additionally, the Quality Manager works within the people management systems in the Company to develop others (performance management, rewards, and selection process) and creates an energizing work environment that supports the Company’s high-performance culture while ensuring an efficient and flexible organization.

Requirements

• Bachelor’s degree
• 7 years of Quality, Manufacturing, and/or Product Development experience.
• 5 years minimum of medical device experience.
• 5+ years experience in demonstrated ability to manage, coach and mentor employees.
• Experience in a metric driven culture.
• Previous experience participating in or leading a Quality audit or section of an audit.
• Knowledge of ISO Quality Systems requirements and FDA GMP and QSR.
• Experience with Electronic Quality Management System.
• Able to review and analyze data and documentation.
• Effective and competent management, leadership, and organizational skills required and valued as part of the leadership team.

Responsibilities

• Leading, development, and management of effective and compliant quality systems.
• Representing the site to all regulatory bodies, including registered notified bodies, and ensuring management review activities are conducted per regulations.
• Managing all client quality systems audits and ensuring timely response to any audit concerns.
• Acting as the primary contact for customers regarding quality related issues/activities.
• Ensuring all field complaints are responded to per regulatory requirements.
• Participating in strategic planning activities to ensure that all quality related requirements are considered when establishing strategic goals and objectives.
• Participating in new product/project development to ensure quality requirements are established.
• Working directly with operating entities to ensure that management controls, product life cycle requirements including risk management, inspections, improve yield and product quality, statistical process control analyses and audits are conducted on a continuing basis as specified to enforce requirements and meet specifications.
• Ensuring that all site quality performance indicators (QPI) metrics presented to the management are in sync with site and global requirements and metrics.
• Participating and supporting lean/continuous improvement initiatives and safety initiatives.
• Ensuring that quality activities are planned, resources allocated, priorities established and activities executed to meet goals.
• Working within the people management systems in the Company to develop others (performance management, rewards and selection process).
• Creating an energizing work environment that supports the Company’s high performance culture while ensuring and efficient and flexible organization.

What This Job Offers

• Job Type: Full-time
• Career Level: Manager