What are the responsibilities and job description for the Manager, Quality Control position at Lensa?
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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
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.
implementation and execution of CAPAs, continuous improvement
initiatives, and other quality initiatives
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.
nonconformity.
Board Review (DBR), Plant Operational reviews etc.
CMDR, MDR and JPAL.
the areas of process / continuous improvements, identify and implement
opportunities.
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 supervises employees in the Quality Inspection, Micro Lab, and
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.
- Builds high performance cultures and teams, empowering and holding
implementation and execution of CAPAs, continuous improvement
initiatives, and other quality initiatives
- Provides strategic direction and communication of the company's goals,
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
nonconformity.
- Oversee product quality reviews, divisional management reviews and
Board Review (DBR), Plant Operational reviews etc.
- Direct the activities of the Quality Department to ensure compliance with
CMDR, MDR and JPAL.
- Ensures site compliance and readiness. Oversees external regulatory
- Interact and coordinate activities with other departments, external vendors
the areas of process / continuous improvements, identify and implement
opportunities.
- Ensure that all projects and validations are in compliance with QSR, ISO
- Participate in evaluation of new product opportunities (introductions,
- Maintain fiscal responsibility and budget compliance.
- Bachelor's degree in engineering, Life Sciences, or a related field (Master's
- 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
- 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.