Quality Assurance Manager

Knowles Precision Devices; New Bedford (MA); On-site; USD 115,000 - 135,000; Full time

Job summary

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.

Qualifications

• 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.

Responsibilities

• 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.

Skills

Quality Management Systems

Regulatory compliance

Root cause investigations

CAPA

Statistical analysis

Cross-functional collaboration

Leadership

Education

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

Tools

SPC

FMEA

CAPA

MSA

Statistical analysis software

Job description

Position Overview

The Quality Assurance Manager is responsible for leading the site's Quality Management System (QMS) and driving a culture of quality throughout manufacturing operations. This role provides strategic and operational leadership to ensure compliance with customer requirements, industry standards, and regulatory expectations while supporting business objectives, product reliability, and continuous improvement initiatives.

Position Overview

The Quality Assurance Manager is responsible for leading the site's Quality Management System (QMS) and driving a culture of quality throughout manufacturing operations. This role provides strategic and operational leadership to ensure compliance with customer requirements, industry standards, and regulatory expectations while supporting business objectives, product reliability, and continuous improvement initiatives. The Quality Assurance Manager serves as the primary customer quality interface, oversees quality systems and personnel, and partners with Engineering, Operations, Supply Chain, and Leadership teams to drive product quality, process capability, and customer satisfaction. Quality Assurance (QA) experience supporting medical device, implantable, or other highly regulated manufacturing environments preferred. Products manufactured at the New Bedford facility primarily serve critical medical technology applications requiring exceptional quality, reliability, and compliance standards.

Duties & Responsibilities

• 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.

Qualifications & Skills

Required Qualifications

• 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.

Preferred Qualifications

• Previous people leadership experience within a manufacturing environment.
• Experience supporting highly regulated industries such as medical devices, implantable technologies, electronics, or advanced manufacturing.
• Working knowledge of ISO 9001 quality standards.
• Experience with ISO 13485 or medical device quality systems.
• ASQ certifications such as Certified Quality Engineer (CQE), Certified Quality Auditor (CQA), or Certified Manager of Quality/Organizational Excellence (CMQ/OE).
• Experience utilizing statistical process control (SPC), process capability analysis, reliability methods, and data-driven quality tools.

Technical Knowledge & Skills

• Strong understanding of quality systems, auditing, risk management, and continuous improvement methodologies.
• Ability to interpret technical specifications, engineering drawings, procedures, and regulatory requirements.
• Demonstrated proficiency in quality tools including SPC, FMEA, CAPA, MSA, and statistical analysis.
• Ability to manage multiple priorities in a fast-paced manufacturing environment.
• Strong leadership and organizational skills with the ability to build effective cross-functional relationships.
• Commitment to creating an inclusive, collaborative, and results-driven culture.

The anticipated salary range for this position is $115,000–$135,000 annually. Actual compensation offered within this range will be determined based on several job-related factors, including educational qualifications, relevant years of experience, demonstrated skills and competencies, performance throughout the interview and selection process, and internal pay equity considerations. Knowles is committed to fair, equitable, and competitive compensation practices.