What are the responsibilities and job description for the Manager, Quality Control position at Integra LifeSciences?
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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
Quality Control. Carries 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.
direct reports and cross-functional teams accountable for successful
implementation and execution of CAPAs, continuous improvement
initiatives, and other quality initiatives
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.
science. Post market surveillance, CAPA, Complaints, reduction of
nonconformity.
preparation of quality reports as applicable for various forums, Divisional
Board Review (DBR), Plant Operational reviews etc.
all appropriate regulations and standards, including FDA, ISO 13485,
CMDR, MDR and JPAL.
inspections, timely follow up and closure of Regulatory commitments.
and customers. Influences and collaborates across stakeholder groups in
the areas of process / continuous improvements, identify and implement
opportunities.
and other regulatory requirements.
enhancements, obsolescence).
REQUIRED QUALIFICATIONS :
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.
