Quality Control Engineer

Job Type

Full-time

Description

Job Title: Quality Control Engineer

Location: Monroe, CT

Position Type: Full-Time

Company Overview:

Biomerics provides contract manufacturing, laser processing, and finishing services to a wide range of industries with a strong commitment to customer service. Biomerics specializes in the most challenging machined and micromachined components, including those used in interventional and medical robotics applications. We pride ourselves in providing a supportive, positive work environment with opportunities for challenge and growth.

Biomerics offers Swiss machining with integrated laser cutting on precision medical tubing. Laser/Swiss machining enables features to be machined and laser cut in the same process. Our core competency lies in smaller medical components, produced with high accuracy and repeatability. Traditional Swiss screw machining capability is also available for rapid prototyping and production.

In addition, Biomerics utilizes 5 axis milling machines capable of producing complex finished components, while holding extremely tight tolerances.

Job Description:

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.

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

Requirements

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.)
• ASQ CQE certification is a plus
• Six Sigma Certified Green or Black Belt is a plus
• 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,…