Senior Engineer, Product Quality

Asks for

• 5whyThe ad says“Champion complex quality investigations and execution (e.g. NCMR, CAPA, Post Market escalations), leveraging structured problem-solving methodologies (e.g. 5why, 8D, Fishbone diagram, etc) and lead cross-functional collaboration to deliver sustainable quality and compliance outcomes.”
• 8DThe ad says“Champion complex quality investigations and execution (e.g. NCMR, CAPA, Post Market escalations), leveraging structured problem-solving methodologies (e.g. 5why, 8D, Fishbone diagram, etc) and lead cross-functional collaboration to deliver sustainable quality and compliance outcomes.”
• CAPAThe ad says“Champion complex quality investigations and execution (e.g. NCMR, CAPA, Post Market escalations), leveraging structured problem-solving methodologies (e.g. 5why, 8D, Fishbone diagram, etc) and lead cross-functional collaboration to deliver sustainable quality and compliance outcomes.”
• Control Plans (PCP)The ad says“Demonstrated expertise in medical device risk management and validation, across product lifecycle, including the development and maintenance of Risk Management Files, PFMEA, Control Plans (PCP), process validation (IQ/OQ/PQ), and the application of risk-based decision-making in compliance with regulatory and quality system requirements.”
• FDA 21 CFR Part 820The ad says“Ensure compliance with applicable regulatory and quality standards, including ISO 9001, ISO 13485, FDA 21 CFR Part 820, MDSAP requirements, and other relevant global regulations governing medical device products and manufacturing processes.”
• Fishbone diagramThe ad says“Champion complex quality investigations and execution (e.g. NCMR, CAPA, Post Market escalations), leveraging structured problem-solving methodologies (e.g. 5why, 8D, Fishbone diagram, etc) and lead cross-functional collaboration to deliver sustainable quality and compliance outcomes.”
• IQ/OQ/PQThe ad says“Demonstrated expertise in medical device risk management and validation, across product lifecycle, including the development and maintenance of Risk Management Files, PFMEA, Control Plans (PCP), process validation (IQ/OQ/PQ), and the application of risk-based decision-making in compliance with regulatory and quality system requirements.”
• ISO 13485The ad says“Ensure compliance with applicable regulatory and quality standards, including ISO 9001, ISO 13485, FDA 21 CFR Part 820, MDSAP requirements, and other relevant global regulations governing medical device products and manufacturing processes.”
• ISO 9001The ad says“Ensure compliance with applicable regulatory and quality standards, including ISO 9001, ISO 13485, FDA 21 CFR Part 820, MDSAP requirements, and other relevant global regulations governing medical device products and manufacturing processes.”
• MDSAPThe ad says“Ensure compliance with applicable regulatory and quality standards, including ISO 9001, ISO 13485, FDA 21 CFR Part 820, MDSAP requirements, and other relevant global regulations governing medical device products and manufacturing processes.”
• NCMRThe ad says“Champion complex quality investigations and execution (e.g. NCMR, CAPA, Post Market escalations), leveraging structured problem-solving methodologies (e.g. 5why, 8D, Fishbone diagram, etc) and lead cross-functional collaboration to deliver sustainable quality and compliance outcomes.”
• PFMEAThe ad says“Demonstrated expertise in medical device risk management and validation, across product lifecycle, including the development and maintenance of Risk Management Files, PFMEA, Control Plans (PCP), process validation (IQ/OQ/PQ), and the application of risk-based decision-making in compliance with regulatory and quality system requirements.”
• Post Market escalationsThe ad says“Champion complex quality investigations and execution (e.g. NCMR, CAPA, Post Market escalations), leveraging structured problem-solving methodologies (e.g. 5why, 8D, Fishbone diagram, etc) and lead cross-functional collaboration to deliver sustainable quality and compliance outcomes.”
• process validationThe ad says“Demonstrated expertise in medical device risk management and validation, across product lifecycle, including the development and maintenance of Risk Management Files, PFMEA, Control Plans (PCP), process validation (IQ/OQ/PQ), and the application of risk-based decision-making in compliance with regulatory and quality system requirements.”
• quality investigationsThe ad says“Champion complex quality investigations and execution (e.g. NCMR, CAPA, Post Market escalations), leveraging structured problem-solving methodologies (e.g. 5why, 8D, Fishbone diagram, etc) and lead cross-functional collaboration to deliver sustainable quality and compliance outcomes.”
• risk managementThe ad says“Demonstrated expertise in medical device risk management and validation, across product lifecycle, including the development and maintenance of Risk Management Files, PFMEA, Control Plans (PCP), process validation (IQ/OQ/PQ), and the application of risk-based decision-making in compliance with regulatory and quality system requirements.”
• verification and validationThe ad says“Exposure to and/or experience with verification and validation of Medical Devices in New Product Introductions.”