Changing lives. Building careers.

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
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.
• Builds 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
• Provides 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 as applicable 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.
• Ensures site compliance and readiness. Oversees external regulatory
inspections, timely follow up and closure of Regulatory commitments.
• Interact and coordinate activities with other departments, external vendors
and customers. Influences and collaborates across stakeholder groups in
the areas of 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.