Technical Lead – Manufacturing & Quality Compliance

Intellectt Inc; Village of Skaneateles (NY); On-site; USD 80,000 - 100,000; Full time

Job summary

An innovative company is seeking a Technical Lead in Manufacturing & Quality Compliance to enhance product quality and regulatory adherence. This role involves remediating critical manufacturing documents, conducting gap assessments, and supporting the introduction of new products while ensuring compliance with FDA regulations. The ideal candidate will possess a strong background in biomedical, mechanical, or industrial engineering, with hands-on experience in quality systems and process risk management. Join a dynamic team and make a significant impact in the medical device industry by driving quality improvements and regulatory compliance.

Qualifications

• Experience in FDA submissions and nonconformance audits is essential.
• Bachelor's degree in engineering is required for this role.

Responsibilities

• Remediate manufacturing documents to meet current standards.
• Monitor and drive corrective actions and continuous improvement.

Skills

FDA 510 K submissions

Nonconformance audits

EU MDR remediation processes

Quality Management Systems (QMS)

Process risk management

Data analysis

Problem-solving

Education

Bachelor’s degree in biomedical engineering

Bachelor’s degree in mechanical engineering

Bachelor’s degree in industrial engineering

Tools

pFMEA

CAPA documentation

Job description

Technical Lead – Manufacturing & Quality Compliance

2 days ago Be among the first 25 applicants

Responsibility:

• Remediate Manufacturing, DHF, DMR Documents of new and legacy products to current organization standards and policies.
• Perform gap assessment and conduct remediation of documents with stakeholder inputs.
• Experienced in FDA 510 K submissions, Nonconformance audits, EU MDR remediation processes.
• Good understanding on the manufacturing specific QMS documents for Class-I, II and III medical devices.
• Supports the development and introduction of new products, processes, and technologies, with focus on quality systems development, regulatory compliance, and process risk management including pFMEA.
• Creation/modification of process flows within the Manufacturing/Service Departments.
• Development and maintenance Manufacturing/Service Work Instructions and related documents.
• Creation/modification of fixtures, tooling, equipment and systems to support operations.
• IQ, OQ, and PQ of fixtures, tooling, and equipment.
• Monitor and drive corrective action, CAPA and continuous improvement activities that directly impact performance measures by performing primary investigations, conducting data analysis, and implementing corrective actions.
• Support corrective and preventive actions in manufacturing using formal problem-solving tools and documentation.
• Medical Device Experience with knowledge of FDA 510 K, IS013485, ISO 14971 standards preferred.

Qualification:

• Bachelor’s degree in biomedical engineering/ mechanical engineering/industrial engineering background

Seniority level

• Mid-Senior level

Employment type

• Contract

Job function

• Engineering and Manufacturing

Industries

• Medical Equipment Manufacturing, Biotechnology Research, and Pharmaceutical Manufacturing