Cortland Company Inc., d/b/a Cortland Biomedical, seeks a Senior Quality Engineer to establish, implement, and maintain the company’s Quality Management System (QMS) in support of ISO 13485:2016 International Standard for Medical Devices and Good Manufacturing Practices. Lead and participate in activities to ensure that the QMS is adequate, suitable, and effective. Duties include:•Establish engineering study protocols and final reports (including deviation processing) using statistical methods and analysis in support of NPD/commercial design, manufacturing, and testing. Examples include EIOQ (hardware and software), test method validation (MSA/GR&R), process characterization, OQ, and PQ.•Participate in and lead product development teams by ensuring design and development planning, input, output, review, verification, validation, and production transfer activities are compliant with established procedures.•Perform formal problem solving, auditing, risk management (PFMEA), and validation/qualification.•Use a variety of statistical techniques including normality analysis, GR&R, capability analysis, and hypothesis testing of continuous and attribute data sets. •Support addition of suppliers to CBM’s ASL including auditing suppliers (finding resolution), implementing SQA’s, managing PPAP deliverables to close, and leading problem-solving to close.•Complete assigned CAPA’s in a timely manner to prevent occurrence and recurrence of issues using disciplined problem-solving techniques to support investigation, concise problem statement, containment, correction, root cause analysis, corrective and preventive action, and verification of effectiveness.•Plan, conduct, and report compliant internal audits (including well documented findings) in a timely manner in support of internal audit schedule and QMS requirements.•Collaborate with others to ensure nonconforming and potentially nonconforming product are accurately documented, identified, segregated, and dispositioned, and associated corrections are implemented.•Support safety policies and procedures in accordance with site requirements and at the direction of corporate health and safety officials.•Ensure quality records are established in support of Good Documentation Practices and records are controlled within QCBD for easy identification and retrieval.•Manage the timely calibration of monitoring and measuring equipment, ensuring out of calibration records are documented to close, all records are reviewed and approved, and records are maintained within QCBD.•Establish item-specific, statistically based quality plans to ensure receiving, in-process, and final inspection requirements are documented, communicated, and maintained within DHR and QCBD.•Analyze data to proactively identify trends/opportunities for KPI improvement, risk reduction, and customer satisfaction.•Provide reports to management and act independently to initiate/lead continuous improvement.•Assist in training company employees in Quality System related procedures and processes.•Supervise Quality Technicians in support of QMS roles, responsibility, and goals. •Work with engineering and operations to ensure that Quality Technician work is prioritized, scheduled, and completed.•Use a variety of other methods, tools, and technologies to perform job duties including Quality Control Statistical Techniques; problem solving tools including Cause and Effect Diagrams and Five-Why methodology; and Good Documentation Practices. Minimum Requirements: Bachelor’s degree in Industrial Engineering, Mechanical Engineering, or a related field plus 5 years post-baccalaureate, progressive experience as a Quality Engineer within medical device manufacturing industry, including experience with Quality Management Systems, auditing, risk management (PFMEA), validation/qualification, and statistical techniques (Normality Analysis, GR&R, Capability Analysis, and Hypothesis Testing of Continuous and Attribute data sets), and ISO 13485 standards.Alternatively, will accept Master’s degree in Industrial Engineering, Mechanical Engineering, or a related field plus 2 years as a Quality Engineer within medical device manufacturing industry, including experience with Quality Management Systems, auditing, risk management (PFMEA), validation/qualification, statistical techniques (Normality Analysis, GR&R, Capability Analysis, and Hypothesis Testing of Continuous and Attribute data sets) and ISO 13485 standards.Job is located at company's Cortland, NY, office but employee may work remotely 2 days per week.To apply, send resume to: brandi.ledet@enerpac.com. Reference job title when applying. Cortland Biomedical is wholly owned by Enerpac Tool Group. Enerpac Tool Group is a premier industrial tools and services company serving a broad and diverse set of customers in more than 100 countries. The company was founded in 1910 and is headquartered in Menomonee Falls, Wisconsin.

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