Senior Quality Engineer

Company : Katalyst Healthcares & Life Sciences

Responsibilities:

• Provide quality engineering support throughout the product development lifecycle by applying ISO 13485, ISO 14971, and FDA design control principles to ensure compliance.
• Serve as a Subject Matter Expert and own Risk Management (Hazards Analysis and FMEAs) across the assigned product / product families (mainly complex electro-mechanical devices).
• Support design verification, validation, and reliability testing.
• Participate in supplier qualifications.
• Identify and implement effective process control systems to support the development, qualification, and on-going manufacturing of products to meet or exceed internal and external requirements, supporting design transfer activities.
• Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.
• Support audits, CAPA investigations, and continuous improvement initiatives.
• Must Haves / Minimum Requirements
• Detailed knowledge of FDA 21CFR 820, GMP, MDD and EU-MDR, and ISO 13485 and ISO 14971.
• Engineering and technical experience and demonstrated use of Quality tools/methodologies.
• Experience with planning and executing design verification testing, test method development and test method validation (hands on execution experience preferred)
• Ability to author technical reports, business correspondence and standard operating procedures.
• Experience with planning and executing process validations (TMV, IQ/OQ/PQ) including authoring of Master Validation Plans and Reports.

Requirements:

• Minimum bachelor's degree in engineering or science and 5+ years' of relevant work experience OR master's degree in engineering or science with 3+ years of work experience in Quality and/or Engineering
• Detailed knowledge of FDA 21CFR 820, ISO 13485, and ISO 14971 to ensure full compliance with design control principles and global medical device regulations like EU-MDR
• serving as a Subject Matter Expert for Risk Management (Hazards Analysis, FMEAs), leading design verification and validation testing, and executing process validations (TMV, IQ/OQ/PQ
• Working knowledge of IEC 62304 and IEC (phone number removed)
• Ability to drive process improvement activities.
• ASQ Certification in Quality or Reliability.
• Ability to multi-task, prioritize, meets/exceed deadlines and holds themselves, and others accountable.

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