Job Title: Quality Engineer
Job Location: Vandalia, OH (Mostly onsite. Some hybrid.)
Hourly Rate: $80k+ based on experience

Job Description:

The 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.

Responsibilities:

• 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 ISO9001, IATF16949 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.

Qualifications:

• Bachelor ‘s Degree in Engineering or Physics

• Minimum of 4 years’ experience as a QE (or equivalent) in the medical device or automotive industry

Preferred Qualifications:

• Current ASQ CQE or CQE in progress

• Risk management implementation per ISO14971 or automotive equivalent standard

• Experience in the practical application of statistical process control, quality techniques and FDA Quality System Regulation and ISO 9001, ISO 13485, TS16949 or equivalent

• General knowledge of manufacturing processes such as injection molding, assembly, packaging, and sterilization required