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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
• Provide technical expertise regarding component schematics and component inspection requirements.
• Identify improvement opportunities related to the quality system and product.
• Ensure the contents of Design History Files (DHF), Device Master Records (DMR), and Device History Records (DHR) are accurately developed and verified.
• As needed oversee the calibration and preventive maintenance program to ensure equipment accuracy and reliability.
• As needed be responsible for managing supplier quality activities, including supplier audits, performance assessments, and quality agreements.
Required Education/Training/ & Experience:
• Bachelor's degree in a scientific/engineering discipline; or equivalent combination of education and experience.
• Minimum 5 years of relevant work experience in either pharmaceutical, medical device, or other highly regulated industry.
Knowledge, skills, and abilities:
• Experience in catheter design and production, or with similar medical devices, while working within Quality is required.
• GMP experience working within ISO 13485, ISO 14976 and FDA 21 CFR Part 820 environments.
• Capable of reviewing and interpreting drawings
• Experience in Risk Management Records and Risk Analysis.
• Experience in performing test method validation and Gage R&Rs
• Understanding of statistical techniques such as normality analysis, tolerance analysis, and should be able to analyze and interpret data with high confidence.
• Must know how to use Minitab or other statistical software
• Expertise in Sterilization (EO) is preferred (ISO 11135)
• Knowledge in biocompatibility is preferred (ISO 10993 and associated variants)
• Strong analytical, planning and organizational skills
• Strong interpersonal and communications skills (oral & written)
• Self-starter with ability to work independently under pressure and react quickly to changing priorities
• Proficient in MS Office Word, Excel, Power Point, Project, Visio.
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