Quality Engineer

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Business Unit:
Paragon Medical Advanced Surgical

Posting Date:
Aug 4, 2025

Job Description:

Job Summary

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. Supports and enforces the development of internal systems and procedures to meet ISO standards and FDA quality system regulations. Develops and implements inspection/validation techniques necessary to verify products meet requirements at the earliest point in the production process.

Specifies and implements new inspection equipment and instructs others in its proper use. Supports and implements 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 manufacturing.
• Ensures cell processes are correctly validated & controlled, considering variability through inspection, sampling plans, or implementation of SPC.
• Completes the implementation and performance of Gage R&R, process capability studies, design of experiments, and summaries to improve quality and provide required deliverables to customers.
• Ensures processes released with use of SPC where applicable and promotes the utilization of SPC.
• Provides 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 the effectiveness of CAPAs.
• May liaise directly with customer representatives.
• Supervises and trains personnel in the inspection of raw materials, in-process, and finished goods using statistical sampling techniques and precision measuring instruments to check conformance to requirements.
• Verifies that all production procedures have been followed and records such as Device Master Records and Device History Records are maintained per FDA & customer requirements and Paragon Medical standards.
• Designs inspection/validation steps to be taken by operations at the point of manufacture and integrates these steps into manufacturing instructions.
• Responsible for creating, implementing, and improving quality systems and procedures to meet ISO 13485, FDA, and customer quality system requirements.
• Works in conjunction with Cell Leaders to ensure CNC machinists are knowledgeable and competent in the use and care of sensitive measuring equipment and related requirements such as calibration, data recording, expected variability, etc.
• Provides day-to-day oversight of quality including batch testing, inspection, calibration, environmental monitoring, qualification, document review, etc.
• Creates and supports ECNs and SCRs (product).
• May authorize, initiate, and/or approve product and process changes.
• Supports internal and external audits of all corporate quality systems and demonstrates compliance through objective evidence.

Education

Preferred 4-year / Bachelor's Degree in Engineering or related field.

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 Word, Excel, PowerPoint, and Minitab. Excellent organizational skills and attention to detail. Demonstrates problem-solving skills, applying effective, data-driven, mistake-proofing concepts. Strong project management skills. Excellent follow-up skills. Able to work with limited supervision and actively participate in a team-oriented, continuous improvement manufacturing environment.

Physical Demands

Frequent sitting, occasional standing, walking. Use hand/fingers to grasp/pinch/grip. Occasional climbing (stairs/ladders) or balancing. Occasional stooping, kneeling, crouching, or crawling.…