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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.

• 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.