Senior Quality Engineer

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 with use 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.
• 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.
• Create and support ECN's and SCR's (product).
• May authorize, initiate and/or approve product and process changes.
• Support both internal and external audits of all corporate quality systems and demonstrate compliance through objective evidence.

Education

• Preferred Bachelors Degree in Engineering or related field

Experience

• 3-5 years experience with tight tolerance measurement systems in machining applications, blueprint reading, GD&T, and a working knowledge of short-run process control methods, DOE, ISO standards, and FDA quality system regulations.

KSA's

• Strong written and verbal communication skills.
• Excellent customer teaming and interpersonal aptitude.
• Strong computer skills including excellent Word, Excel, PowerPoint, and Minitab skills.
• Excellent organizational skills and attention to detail required.
• Demonstrates problem solving skills, applying effective, data-driven, mistake-proofing concepts.
• Strong project management skills required.
• Excellent follow-up skills required.
• Individual is able to work with limited supervision and actively participate in a team-oriented, continuous improvement, manufacturing environment.

Physical Demands

• Frequent sitting, occasional standing, occasional walking.
• Use hand/fingers to grasp/pinch/grip
• Occasional climbing (stairs/ladders) or balancing.
• Occasional stoop, kneel, crouch, or crawl.
• Occasional operating of machineryand/or hand power tools.