Quality Assurance Lead

2 weeks ago


Shirley, New York, United States Biodex Rehab Full time

Position Overview:

Oversee the Quality Assurance and inspection operations to ensure compliance with industry standards for both internal assembly processes and external vendor interactions. This role is pivotal in maintaining adherence to quality benchmarks for all incoming and outgoing products. Conduct audits and evaluations to ensure all operations align with ISO certification standards.

Leadership Responsibilities:

· Responsible for the recruitment, interviewing, onboarding, and training of new team members within the department.

· Manage the daily activities and workflow of the Quality Assurance team.

· Provide timely and constructive feedback through performance evaluations.

· Address disciplinary actions and terminations in line with organizational policies.

Key Responsibilities:

· Develop and maintain the Quality Assurance Manual, which includes Standard Operating Procedures (SOPs) and Workmanship Standards, ensuring effective documentation control.

· Ensure that root cause analyses and corrective actions are established and monitored according to established protocols. Oversee the corrective and preventive action programs, ensuring resolutions are tracked and verified.

· Lead the Materials Review Board (MRB) and manage the flow of Discrepant Materials, ensuring timely and appropriate resolutions are achieved. Conduct regular audits of open Discrepant Material Reports (DMRs) to minimize outstanding issues.

· Collaborate with various departments to uphold the company's ISO certification, ensuring compliance with FDA, MDR, and other international regulatory bodies.

· Act as the designated Person Responsible for Regulatory Compliance (PRRC), interfacing with registrars and external auditors as necessary to maintain certifications.

· Serve as the Management Representative, responsible for organizing and leading Management Review meetings.

· Create and implement inspection protocols for all new products entering production, including incoming materials. Develop control plans and direct inspection methodologies.

· Conduct trend analyses of customer complaints and other non-conformities, implementing statistical process control as required.

· Ensure adherence to product specifications and quality standards, establishing acceptance criteria and verifying compliance with regulatory requirements (e.g., RoHS, UDI, calibration certificates, labeling).

· Audit and enhance supplier performance in collaboration with the materials department, focusing on quality sampling techniques and addressing specific quality challenges to improve delivery and acceptance rates.

· Act as a hands-on manager with expertise in inspection techniques, ready to assist when necessary.

· Perform additional duties as required.

Essential Skills and Qualifications:

· Exceptional verbal and written communication abilities.

· Strong organizational skills with a keen attention to detail.

· Proven time management skills with the ability to meet deadlines effectively.

· Strong analytical and problem-solving capabilities.

· Demonstrated supervisory and leadership skills.

· Ability to prioritize and delegate tasks appropriately.

· Proficient in Microsoft Office Suite or similar software applications.



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