Establish, implement, and maintain Cortland Biomedical’s (CBM) Quality Management System (QMS) in support of ISO 13485:2016 International Standard for Medical Devices and Good Manufacturing Practices. Lead and participate in activity to ensure that the QMS is adequate, suitable, and effective.
- Support safety policy and procedure in accordance with site requirements and at the direction from corporate health and safety.
- Ensure quality records are established in support of Good Documentation Practice, demonstrate the effective operation of the QMS, and records are controlled within QCBD for easy identification and retrieval.
- Participate and lead product development teams by ensuring design and development planning, input, output, review, verification, validation, and production transfer activity are compliant with established procedure.
- In support of NPD/Commercial design, manufacturing, and test, establish engineering study protocols and final reports (including deviation processing), using statistical methods and analysis. Examples include EIOQ (hardware and software), Test Method Validation (MSA/GR&R), Process Characterization, OQ, and PQ.
- Support addition of suppliers to CBM’s ASL. Critical activity includes supplier auditing (finding resolution), implementing SQA’s, managing PPAP deliverables to close, and leading problem-solving to close.
- Manage the timely calibration of monitoring and measuring equipment, ensure out of calibration records are documented to close, all records are reviewed and approved, and records are maintained within QCBD.
- Plan internal audits, conduct, and report compliant internal audits (including well documented findings) in a timely manner in support of internal audit schedule and QMS requirements.
- Establish item specific, statistically based, Quality Plans to ensure receiving, in-process, and final inspection requirements are documented, communicated, and associated records maintained within DHR and QCBD.
- Manage and collaborate with others to ensure nonconforming and potentially nonconforming product are accurately documented, identified, segregated, dispositioned, and associated corrections are implemented.
- Analyse data to proactively identify trends/opportunity for KPI improvement, risk reduction, and customer satisfaction. Provide reports to management and act independently to initiate/lead continuous improvement.
- 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.
- Assists in the training of company employees in Quality System related procedures or processes.
- Lead 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 complete on time. Participate in year-end review of Quality Technician performance and communicate improvement opportunity as required.
Required Capabilities (describe scope of knowledge and ability of the position):
- BS Degree in Electrical, Industrial, Mechanical, Biomedical, or Textile Engineering or Technology from an accredited university.
- 5+ year experience in a quality engineering function within a manufacturing environment. Medical device manufacturing is preferred.
- Effective verbal and written communication skills and comfortable interacting with team members and customers at all levels.
- Must possess a thorough understanding of Quality Management Systems and the ability to establish and review quality documents and records (commensurate with Key Responsibilities) for accuracy and compliance.
- Demonstrated experience within formal problem solving, auditing, risk management (PFMEA), validation/qualification, and statistical techniques (Normality Analysis, GR&R, Capability Analysis, and Hypothesis Testing of Continuous and Attribute data sets).
- Self-sufficient and able to complete the Key Responsibilities in a compliant manner with little or no guidance.