What are the responsibilities and job description for the Senior Quality Engineer position at Katalyst CRO?
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.
- 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 60601-1
- 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.