Katalyst Healthcares and Life Sciences
Quality Engineer
Katalyst Healthcares and Life Sciences, Wheeling, Illinois, United States, 60090
Responsibilities:
Provide comprehensive quality support for operations and NPI activities, ensuring compliance with ISO 13485 (or AS9100/IATF 16949) and FDA CFR820 standards. Lead and document root cause analyses, CAPA, and nonconformance investigations for customer complaints, supplier issues, and nonconforming materials. Support and document validation efforts (IQ/OQ/PQ) for processes, equipment, and products; maintain validation documentation. Perform capability studies (Cpk), FMEA, and advanced metrology practices (GD&T); analyse and organize data using Minitab, Excel, and related tools. Resolve customer complaints and product issues, maintaining professional communication and data-driven solutions. Collaborate with inspectors and technicians on product inspection and testing using vision systems, CMMs, calliper's, micrometres, and more. Interface with suppliers and internal teams to drive process improvements, maintain documentation control, and foster a continuous improvement culture. Ensure all quality activities align with regulatory, customer, and internal requirements; participate in internal and external audits. Requirements:
Bachelor's degree in engineering required. Minimum 8 years of quality engineering experience in medical device manufacturing (aerospace or automotive experience also considered). Expertise in ISO 13485, FDA CFR820, AS9100, or IATF 16949 standards. Proven experience leading CAPA, Client activities, and validations in manufacturing settings. Experience collaborating with customers to resolve complaints and product issues. dvanced knowledge of metrology, GD&T, and interpreting CAD/blueprints. Hands-on experience with industrial machinery such as CNC, EDM, and finishing equipment preferred. Proficient in Minitab, Excel, and technical documentation software. Strong leadership, communication, and process ownership skills.
Provide comprehensive quality support for operations and NPI activities, ensuring compliance with ISO 13485 (or AS9100/IATF 16949) and FDA CFR820 standards. Lead and document root cause analyses, CAPA, and nonconformance investigations for customer complaints, supplier issues, and nonconforming materials. Support and document validation efforts (IQ/OQ/PQ) for processes, equipment, and products; maintain validation documentation. Perform capability studies (Cpk), FMEA, and advanced metrology practices (GD&T); analyse and organize data using Minitab, Excel, and related tools. Resolve customer complaints and product issues, maintaining professional communication and data-driven solutions. Collaborate with inspectors and technicians on product inspection and testing using vision systems, CMMs, calliper's, micrometres, and more. Interface with suppliers and internal teams to drive process improvements, maintain documentation control, and foster a continuous improvement culture. Ensure all quality activities align with regulatory, customer, and internal requirements; participate in internal and external audits. Requirements:
Bachelor's degree in engineering required. Minimum 8 years of quality engineering experience in medical device manufacturing (aerospace or automotive experience also considered). Expertise in ISO 13485, FDA CFR820, AS9100, or IATF 16949 standards. Proven experience leading CAPA, Client activities, and validations in manufacturing settings. Experience collaborating with customers to resolve complaints and product issues. dvanced knowledge of metrology, GD&T, and interpreting CAD/blueprints. Hands-on experience with industrial machinery such as CNC, EDM, and finishing equipment preferred. Proficient in Minitab, Excel, and technical documentation software. Strong leadership, communication, and process ownership skills.