Quality Control Engineer

Biomerics•Monroe, CT

About The Position

The Quality Control 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, communication on quality initiatives to support departmental, functional, site, divisional, and corporate quality goals and priorities. As the Quality Engineer, you will lead Quality Assurance (QA) in support of manufacturing activities in accordance with the requirements of USFDA CFR 820 and ISO 13485.

Requirements

Bachelor's Degree in Engineering, Biomedical Engineering, or related science discipline
Minimum of 3 years' experience in Quality Engineering within a Medical Device Manufacturing environment for a company in a regulated industry (IVD, pharmaceuticals, medical device, biologics, etc.)
Working knowledge of FDA QSR (21 CFR Part 820), ISO 13485, MDD/AIMDD, CMDR; Ability to understand other medical device regulations and standards
Experience in nonconforming material and CAPA methodologies/systems preferred
Strong communication, presentation, facilitation, and project management skills
Experience working in cross-functional teams and driving projects to completion
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
Ability to develop effective, positive interpersonal relationship

Nice To Haves

ASQ CQE certification is a plus
Six Sigma Certified Green or Black Belt is a plus

Responsibilities

Perform Quality Assurance and Quality Control in support of manufacturing activities in accordance with the requirements of USFDA CFR 820 and ISO 13485.
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
Collects and analyzes process defect data for product/process improvement efforts (e.g. scrap, nonconforming product, customer complaints) by systematically gathering quality metric data and performing the appropriate analysis method(s)
Owns and drives Nonconforming Event and Correction and Preventive Action investigations
Supports continuous improvement activities, NCMRs, CAPA, and Lean initiatives
Perform validation activities as established by USFDA CRF 820, ISO 13485, and other regulatory bodies as required.
Support engineering efforts by developing, implementing, and maintaining quality requirements and standards throughout the transfer and manufacturing of products.
Responsible for creating control plans and risk analyses (PFMEAs)
Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues