Senior Quality Engineer

Job Description

DIRECT CANDIDATES ONLY, IF INTERESTED APPLY THROUGH JOB POST. NO DIRECT MESSAGES.

RECRUITERS : DO NOT CONTACT.

Position overview : The Senior Quality Engineer will be responsible for providing quality engineering support and leadership for Manufacturing Process development and implementation. This position will work closely Manufacturing in the manufacture of disposable medical catheters in compliance with applicable regulatory and statutory requirement.

Essential Duties and Responsibilities :

• Oversee EO sterilization validation processes and ensure routine sterilization activities meet regulatory standards.
• Support environmental monitoring and clean room verifications according to schedule and assist with excursion investigations.
• Review and approve manufacturing validation test plans, protocols, and test reports.
• Lead the completion of risk management deliverables, including process Failure Mode and Effects Analysis (pFMEA) and Control Plans.
• Support and lead test method validation activities to ensure accurate and reliable testing processes.
• Develop, review, and approve inspection plans, Device History Records (DHR), and product drawings for new products.
• Create and implement quality plans as needed to ensure product and process compliance.
• Develop activities aimed at preventing and detecting defects during the manufacturing process.
• Recommend and provide statistical support, expertise, and analytical problem-solving for process validations and Engineering Protocols.
• Support activities related to Management Reviews, internal and external audits, deviations, Corrective and Preventive Actions (CAPA), Non-Conformance Reports (NCR), Supplier Management, and Returned Goods Authorization (RGA).
• Provide support to the New Product Development team activities.
• Lead the resolution of quality issues related to NCRs and CAPAs.
• Ensure compliance with quality system procedures and all regulatory requirements.

Technical Expertise

Required Education / Training / & Experience :

Knowledge, skills, and abilities :