Senior Quality Engineer - Medical, Validations

Come Innovate MedTech with us!

The Senior Quality Engineer for Vandalia, OH., will support all aspects of the Quality Assurance (QA) program within the Quality Management System (QMS). The QE reports to the Q&R Manager. This position will lead all customer and third-party quality audits. Participate in Design Project Teams as a QE/QA Representative to ensure that input requirements (internal, external, and customer) are clearly defined, risk assessment is performed, output meets input requirements, and objective evidence clearly supports conclusions. Perform quality related design control activities as assigned by Design Project Team. Partner with production during Design Transfer phase to ensure that products and processes meet all quality requirements.

Your responsibilities will be:

Responsible for the development and implementation of validation test plans

Lead QE function within new product teams to ensure customer and regulatory requirements are met along the product development cycle.

Develop and implement quality system per ISO13485 and customer requirements. Create production, calibration, inspection, and maintenance procedures as required.

Use Failure Modes Effects Analysis (FMEA), Fault Tree Analysis (FTA), Fish Bone Diagram, Risk Analysis, or other appropriate quality tools to define and manage risk or identify root cause of failure.

Lead the resolution of quality issues related to non-conformance reports, customer complaints, regulatory actions, etc. Support CAPA investigations and related corrective and preventive actions.

Assist in development, review and approval of process and equipment validation/qualifications (IQ, OQ, PQ). Develop, review and improve inspection plans, standard work sheet and product drawings.

Lead continuous improvement activities. Support Kaizen activities and re-work/scrap reduction.

Active member of core launch teams and provide support for control plan and FMEA development.

Working knowledge of lessons learned and ensure that all concerns are addressed during plan development.

Review test plans with appropriate people to ensure that all requirements are agreed upon and understood, including timing.

Obtain customer approval for the validation plans when appropriate.

Work with validation to ensure that all testing is completed accurately and on time. Update the plan with the results.

Understand and communicate customer testing requirements, work with team to understand, and interpret, ambiguous specifications.

Develop internal (minimum) test requirements for common products, materials, and processes.

Assist in test methodology, statistical analysis, and test scheduling.

Maintain a working understanding of required regulatory requirements.

Maintain current knowledge of applicable customer test requirements for both design and process validation.

Other duties as assigned by manager

Our Requirement:

Bachelor’s Degree in Engineering, Material Science or related field with 3 years of experience (preferably in manufacturing).

Strong analytical and problem-solving skills.

Knowledge of data analysis methods and statistical quality tools.

Excellent communication and organizational skills

Project management skills with a strong attention to detail.

Ability to interface effectively with all levels of the organization including external customers, program managers, engineers, R&D, production associates, etc.

Working knowledge of Control Plans, FMEAs, APQP and Process Control.

Working knowledge of Validations including IQ, OQ, PQ.

No sponsorship needed for H1B Visa Status

What We offer:

JE offers talented employee’s exceptional opportunities to learn and grow professionally with rewarding careers. We offer a competitive benefits package including medical, dental, prescription plan, vision, disability coverage, life insurance coverage, 401K match, and holiday/vacation benefits.