Quality Control Engineer

Biomerics•Athens, TX

47d

About The Position

A Quality Engineer is responsible for providing Quality Engineering input to support Medical Device Manufacturing, Manufacturing Engineering, Operations, and Distribution activities. The QE will develop, establish, and maintain quality engineering methodologies, systems, and practices that meet Biomerics, customer, and regulatory requirements. You will serve as a Quality representative to improve awareness, visibility, and communication on quality initiatives to support departmental, functional, site, divisional, and corporate quality goals and priorities. You may support new product development (NPD) as needed. As the Quality Engineer, you will lead Quality Assurance (QA) in support of manufacturing activities in accordance with the requirements of USFDA CFR 820, ISO 13485, and MHLW Ministerial.

Requirements

Bachelor’s Degree in Engineering, Biomedical Engineering, or related science discipline.
ASQ / CQE certifications
Six Sigma Certified Green or Black Belt
Minimum of 5 years’ experience in Quality Engineering within a Medical Device Manufacturing environment.
Working knowledge of FDA QSR (21 CFR Part 820), ISO 13485, MDD/AIMDD, CMDR, JPAL medical device regulations; Ability to understand other medical device regulations and standards
Experience in nonconforming material and CAPA methodologies/systems preferred
Familiar with Microsoft Office Suite, and Minitab Statistical Analysis software (or equivalent)
High sense of urgency and commitment to execution
Applies continuous improvement principles in the development of the quality system
Driven, energetic, self-assured professional with high personal integrity
Knowledge of analytical techniques and statistical analysis

Responsibilities

Lead Quality Assurance in support of manufacturing activities in accordance with the requirements of USFDA CFR 820, ISO 13485, and MHLW Ministerial Ordinance 169.
Manage validation activities as established by USFDA CRF 820, ISO 13485, MHLW Ministerial Ordinance 169, and other regulatory bodies as required.
Support engineering efforts by developing, implementing, and maintaining quality requirements and standards throughout the design transfer and manufacturing of products.
Reduces and controls Manufacturing process defects (scrap, nonconforming material, customer complaints), leading or participating in efforts and cross-functional teams focused on identifying the primary root causes and implementing corrective and preventative actions.
May be responsible for creating risk analyses and FMEAs
Collects and analyzes process defect date for product/process improvement efforts (e.g., scrap, nonconforming product, customer complaints) by systematically gathering metric data and performing the appropriate analysis method(s) to enhance sustaining product design and new product development.
Owns and drives Nonconforming Event and Correction and Preventative Action investigations
Supports continuous improvement activities, NCEPs, CAPA, and Lean initiatives
Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.
Support internal and external regulatory audits.