Spec 3, Quality Assurance

KAYGEN•Mannford, OK

1d•Onsite

About The Position

KAYGEN is seeking a Quality Assurance professional to support manufacturing process risk identification, evaluation, and mitigation for day-to-day operations, new product introduction, and continuous improvement of the quality management system. The role handles multiple projects and programs while meeting key deadlines, integrates business and functional priorities to address complex problems and non-standard situations, and contributes in a complex environment while working independently with minimal guidance. The position is onsite five days a week.

Requirements

Bachelor of Science in an engineering discipline or equivalent.
Knowledge of 12CRF820, ISO 13485, and ISO 14971.
CQE and CSSBB.
Experience leading or creating PFMEAs and control plans.
Experience with PPAP close.
Knowledge of process risk management activities and quality management systems.
Knowledge and skills within the Quality Engineering Body of Knowledge.
Proficiency with Minitab or equivalent, MS Word, and Excel.
Problem-solving ability.
Strong interpersonal skills.
Ability to work independently with minimal guidance.

Responsibilities

Support manufacturing process risk identification, evaluation, and mitigation for day-to-day operations, new product introduction, and continuous improvement of the quality management system.
Lead or create PFMEAs and control plans using product and process knowledge and operator observations.
Conduct supplier and quality system audits.
Create and provide training.
Create, review, and coordinate test protocols and reports.
Manage multiple projects and programs while meeting key deadlines.
Address complex problems and non-standard situations by integrating business and functional priorities.