QA Manager - Medical Device Quality & Compliance

Knowles Precision Devices; New Bedford (MA); Vor Ort; USD 115.000 - 135.000; Vollzeit

Zusammenfassung

Knowles Precision Devices is seeking a Quality Assurance Manager to lead the site’s Quality Management System and drive a culture of quality across manufacturing. You will partner with Engineering, Operations, and Supply Chain to assure product reliability, regulatory compliance, and continuous improvement while serving as the primary customer quality interface.

The role requires 7 years of manufacturing quality experience and 2 years of direct management.

Qualifikationen

• Bachelor’s degree in Engineering, Manufacturing, Quality, Science, or a related technical field.
• 7 years of progressive quality experience within a manufacturing environment.
• 2 years direct management experience leading quality teams, engineers, and quality assurance functions.
• Strong knowledge of Quality Management Systems and regulatory compliance requirements.
• Experience leading root cause investigations, corrective actions, and continuous improvement initiatives.
• Proven ability to influence and collaborate across multiple functions and levels within the organization.
• Strong analytical, problem-solving, and decision-making skills.
• Excellent written, verbal, and presentation communication skills.

Aufgaben

• Lead and continuously improve the site's Quality Management System (QMS) to ensure compliance with applicable industry standards, customer requirements, and internal procedures.
• Develop and execute quality strategies that support operational excellence, product reliability, and business growth objectives.
• Serve as the primary customer quality contact for product performance, reliability, corrective actions, and quality-related concerns.
• Drive root cause investigations and corrective and preventive actions (CAPA) utilizing structured problem-solving methodologies, including 8D, RCA, and statistical analysis techniques.
• Partner with Engineering and Operations teams to ensure quality is built into new product introductions, process changes, and manufacturing operations.
• Analyze quality performance metrics, communicate trends, and provide actionable recommendations to leadership.
• Lead internal and external audits and ensure timely resolution of audit findings and compliance gaps.
• Establish and monitor key quality indicators, process controls, and continuous improvement initiatives to reduce defects and improve process capability.
• Collaborate with cross-functional teams to identify risks, implement improvements, and optimize manufacturing and testing processes.
• Support supplier quality initiatives and work with internal stakeholders to address quality issues affecting customer satisfaction and operational performance.
• Develop, coach, and lead a high-performing quality organization through effective talent management, succession planning, and employee development.
• Participate in strategic planning, budgeting, and resource allocation activities to support quality objectives and business priorities.
• Promote a culture of accountability, continuous improvement, and operational excellence across the organization.

Kenntnisse

Quality Management Systems

Regulatory compliance

Root cause investigations

CAPA

Statistical analysis

Cross-functional collaboration

Leadership

Ausbildung

Bachelor's degree in Engineering/Manufacturing/Quality/Science

Tools

SPC

FMEA

CAPA

MSA

Statistical analysis software

Jobbeschreibung

Knowles Precision Devices is seeking a Quality Assurance Manager to lead the site’s Quality Management System and drive a culture of quality across manufacturing. You will partner with Engineering, Operations, and Supply Chain to assure product reliability, regulatory compliance, and continuous improvement while serving as the primary customer quality interface.

The role requires 7 years of manufacturing quality experience and 2 years of direct management.