Senior Quality Engineer

As the Senior Quality Engineer you will be responsible for meeting customer requirements for the manufacturing of surgical instruments and implants or instrument delivery systems from receiving raw material to the shipping of finished goods. You will support and enforce the development of internal systems and procedures to meet ISO standards and FDA quality system regulations. You will develop and implement inspection/validation techniques necessary to verify products meet requirements at earliest point in the production process. You will specify and implement new inspection equipment and instructs others inits proper use. You will support and implement systems in the areas of SPC, advanced quality, and design/development.

Duties and Responsibilities

• Assists in the development and implementation of systems and processes that foster continuous improvement for product development and/or manufacturing.
• Responsible for ensuring cell processes are correctly base-lined & controlled. Known variability is to be accounted for through selection & frequency of inspection, sampling plans, or implementation of SPC.
• Completes the implementation and performance of gage R&R, process capability studies, design of experiments, and summaries as required to improve quality and to provide required deliverables to customers.
• Ensures processes released withuse of SPC where applicable and/or promote the utilization of SPC.
• Provides SPC & ongoing monitoring of SPC.
• Investigates deviations, OOS, complaints, returns, recalls, and field alerts.
• Supports the Material Review Board (MRB) for internal non-conformances and customer returns.
• May lead or verify effectiveness of corrective and preventive actions (CAPAs).
• May liaise directly with customer representatives.
• Supervise and train personnel in the inspection of raw materials, in-process and finished goods by using statistical sampling techniques and precision measuring instruments to check conformance to requirements.
• Verify that all production procedures have been followed and the records such as Device Master Records and Device History Records are maintained per FDA & customer requirements and Paragon Medical requirements.
• Design inspection/validation steps to be taken by operations at the point of manufacture and integrate these steps into the manufacturing instructions.
• Responsible to create, implement and improve quality systems and procedures for meeting ISO 13485, FDA and customer quality system requirements.
• Work in conjunction with Operations Team to ensure users are knowledgeable and competent in the use and care of sensitive measuring equipment and related requirements such as calibration, recording of data, expected variability, etc.
• Provide day-to-day oversight of quality including batch testing, inspection, calibration, environmental monitoring, qualification, document review, etc.
• Creates and supports ECN's and SCR's (product).
• May authorize, initiate and/or approve product and process changes.
• Supports both internal and external audits of all corporate quality systems and demonstrates compliance through objective evidence.
• Demonstrated ability and willingness to use AI tools to improve productivity, decision-making, work quality, and to reduce costs. The successful candidate must be able to identify appropriate AI use cases and critically evaluate AI-generated outputs.