Quality Manager

Responsibilities

• Lead, develop, and manage effective and compliant quality systems.
• Closely work with various cross-functional members of the site to ensure all requirements are described and meet the needs of regulations and functional excellence.
• Serve as the Management Representative responsible for representing the site to all regulatory bodies, including registered notified bodies, and ensure management review activities are conducted per regulations.
• Manage all client quality systems audits and ensure timely responses to any audit concerns.
• Act as the primary contact for customers regarding quality-related issues and activities.
• Ensure all field complaints are responded to in accordance with regulatory requirements.
• Participate in strategic planning activities to ensure that all quality-related requirements are considered when establishing strategic goals and objectives.
• Participate in new product/project development to ensure quality requirements are established.
• Work 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.
• Ensure that all site quality performance indicators (QPI) metrics presented to the management are in sync with site and global requirements and metrics.
• Participate and support lean/continuous improvement initiatives and safety initiatives.
• Ensure the quality activities are planned, resources allocated, priorities established, and activities executed to meet goals.
• Work within the people management systems in the Company to develop others (performance management, rewards and selection process).
• Create an energizing work environment that supports the Company’s high-performance culture while ensuring and 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.
• Demonstrated experience in a metric-driven culture.
• Previous experience participating in or leading a Quality audit or section of an audit.
• Experience with 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.

Qualifications

• Master’s degree preferred.
• Pharmaceutical industry experience preferred.
• Experience in a regulated environment (e.g., FDA, ISO).
• Experience with Lean Six Sigma methodologies.
• Experience with statistical process control (SPC).
• Experience with electronic quality management systems (EQMS).
• Experience with regulatory compliance and auditing processes.

Benefits

• 401K Match: Save for retirement with the company’s help.
• Diversity & Inclusion: We focus on providing an inclusive environment and recognize our diversity contributes to our success.
• Personal Development: We offer a variety of trainings to ensure you can develop in your career.
• Sustainability & Social Commitment: We support social and sustainable projects and encourage employee involvement.
• Corporate Events: We celebrate success as a team, because only together can we achieve our goals.

Pay

The expected salary range for this position is $120,000 to $140,000 annually, depending on skills, experience, and qualifications.

Schedule

On-site at Freudenberg Medical LLC in Beverly, MA.