Manager, Quality Control

Integra LifeSciences; Braintree (MA); On-site; USD 80,000 - 110,000; Full time

Job summary

A leading company in medical equipment manufacturing is seeking a Manager of Quality Control to oversee the QC department. This role involves ensuring compliance with regulatory standards, managing a team, and driving continuous improvement initiatives. The ideal candidate will have a strong background in quality assurance within the medical device industry and possess excellent leadership and analytical skills.

Qualifications

• Minimum of 5 years of experience in Quality Control or Quality Assurance in the medical device industry.
• Strong knowledge of FDA regulations and medical device standards.
• Experience with nonconformance management, CAPA, and audits.

Responsibilities

• Oversee day-to-day operations of the QC department ensuring compliance with regulatory standards.
• Directly supervise employees and manage quality initiatives.
• Ensure product reliability and oversee external regulatory inspections.

Skills

Leadership

Analytical skills

Problem-solving

Communication

Education

Bachelor’s degree in engineering, Life Sciences, or related field

Master’s degree (preferred)

Job description

Join us to apply for the Manager, Quality Control role at Integra LifeSciences.

Getting AI-powered advice on this job and more exclusive features.

Changing lives. Building Careers.

Joining us is a chance for you to do important work that creates change and shapes the future of healthcare. Thinking differently is what we do best. To us, change equals opportunity. Every day, more than 4,000 of us are challenging what’s possible and making headway to help improve outcomes.

The Manager of Quality Control (QC) will oversee the day-to-day operations of the QC department, ensuring that all medical devices meet regulatory standards and customer specifications. This role requires strong leadership, technical expertise, and a deep understanding of all global quality regulations and standards in the medical device industry. The QC Manager will work cross-functionally with other departments to support continuous improvement initiatives and ensure that all products are safe, effective, and compliant.

Responsibilities:

• Directly supervise employees in the Quality Inspection, Micro Lab, and Quality Control. Carry out supervisory responsibilities in accordance with the organization’s policies and applicable laws. Responsibilities include interviewing, hiring and training employees; planning, assigning and directing work; appraising performance; rewarding and disciplining employees; addressing complaints and resolving problems.
• Build high performance cultures and teams, empowering and holding direct reports and cross-functional teams accountable for successful implementation and execution of CAPAs, continuous improvement initiatives, and other quality initiatives.
• Provide strategic direction and communication of the company’s goals, directives, and policies to subordinates, creating a clear vision and positive, team-oriented environment resulting in the achievement of the company’s goals and increased profitability.
• Ensure dependable and timely results from quality control, including process control and support for process changes in compliance with QSR, ISO and other regulatory requirements.
• Ensure and improve product reliability through proven quality science. Post market surveillance, CAPA, complaints, reduction of nonconformity.
• Oversee product quality reviews, divisional management reviews, and preparation of quality reports for various forums, Divisional Board Review (DBR), Plant Operational reviews, etc.
• Direct the activities of the Quality Department to ensure compliance with all appropriate regulations and standards, including FDA, ISO 13485, CMDR, MDR, and JPAL.
• Ensure site compliance and readiness. Oversee external regulatory inspections, timely follow-up, and closure of Regulatory commitments.
• Interact and coordinate activities with other departments, external vendors, and customers. Influence and collaborate across stakeholder groups in process/continuous improvements, identify, and implement opportunities.
• Ensure that all projects and validations are in compliance with QSR, ISO, and other regulatory requirements.
• Participate in evaluation of new product opportunities (introductions, enhancements, obsolescence).
• Maintain fiscal responsibility and budget compliance.

Required Qualifications:

• Bachelor’s degree in engineering, Life Sciences, or a related field (Master’s degree preferred).
• Minimum of 5 years of experience in Quality Control or Quality Assurance in the medical device industry.
• Strong knowledge of FDA regulations and other relevant medical device standards.
• Proven leadership experience with the ability to manage and motivate a team.
• Strong analytical and problem-solving skills.
• Excellent communication skills, both written and verbal.
• Experience with nonconformance management, CAPA, and audits.

Additional Information:

• Seniority level: Mid-Senior level
• Employment type: Full-time
• Job function: Quality Assurance
• Industries: Medical Equipment Manufacturing