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Quality Control Engineer
Quality Control EngineerBiomerics • Monroe, CT, US
Quality Control Engineer

Quality Control Engineer

Biomerics • Monroe, CT, US
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Overview

Job Title : Quality Control Engineer

Location : Monroe, CT

Position Type : Full-Time

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) by leading or participating in cross-functional teams focused on identifying primary root causes and implementing corrective and preventive 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 Corrective and Preventive Action investigations.
  • Supports continuous improvement activities, NCMRs, CAPA, and Lean initiatives.
  • Performs validation activities as established by USFDA CFR 820, ISO 13485, and other regulatory bodies as required.
  • Supports 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

  • 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 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, self-assured professional with high personal integrity.
  • Knowledge of analytical techniques and statistical analysis.
  • Ability to develop effective, positive interpersonal relationships.

    • Equal Opportunity Employer : Minority, Female, Protected Veteran, Individual with Disabilities are encouraged to apply.

    Benefits : Medical / Dental / Vision Insurance, Short-Term Disability, Long-Term Disability, Life Insurance, Paid Vacation Days, Paid Holidays, 401k

    Note : Biomerics does not accept unsolicited resumes or candidate submittals from recruitment agencies not on Biomerics approved agency list. We are not using recruitment services for this or any other role posted.

    Salary : Salary estimates are provided for planning purposes and are not a guarantee. Salary range : $85k - $95k

    Job Details

  • Seniority level

    • Mid-Senior level

  • Employment type

    • Full-time

  • Job function

    • Quality Assurance

  • Industries

    • Medical Equipment Manufacturing

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    Quality Control • Monroe, CT, US