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Contractual Quality Engineer Fda Jobs in Indiana

The Design Quality Engineer will be responsible for the quality and regulatory related activities ... Experience with ISO 13485, FDA 21 CFR 820 Quality System Regulation, ISO 14971, MDR, or associated ...

... and contractual requirements. * Document supplier audit findings and work with suppliers and ... Collaborate with internal Quality and Engineering teams to determine appropriate validation ...

Quality EngineerWarsaw, IN

Warsaw, IN · On-site

$69K - $89K/yr

Ability to read and understand engineering drawings * Knowledge of Quality System requirements, ISO and FDA requirements (preferred) * Ability to effectively work within a team to expedite completion ...

Quality EngineerWarsaw, IN

Warsaw, IN · On-site

$69K - $89K/yr

Ability to read and understand engineering drawings * Knowledge of Quality System requirements, ISO and FDA requirements (preferred) * Ability to effectively work within a team to expedite completion ...

... Engineer in establishing, implementing, and maintaining the Quality Management System. · Complete product inspections in accordance with FDA guidelines for cGMP amp; ISO 13485 · Ensure adherence ...

Mgr Quality Engineering I

Mishawaka, IN · On-site

$66K - $85K/yr

Establish and maintain Product Quality Standards in compliance with customer, contractual ... Lead APQP planning, validation, and execution for new programs and engineering changes, including ...

Mgr Quality Engineering I

Mishawaka, IN · On-site

$66K - $85K/yr

Establish and maintain Product Quality Standards in compliance with customer, contractual ... Lead APQP planning, validation, and execution for new programs and engineering changes, including ...

Establish and maintain Product Quality Standards in compliance with customer, contractual ... Lead APQP planning, validation, and execution for new programs and engineering changes, including ...

Mgr Quality Engineering I

Mishawaka, IN

$66K - $85K/yr

Establish and maintain Product Quality Standards in compliance with customer, contractual ... Lead APQP planning, validation, and execution for new programs and engineering changes, including ...

Showing results 21-40

Contractual Quality Engineer Fda information

What is the difference between Contractual Quality Engineer Fda vs Contract Quality Engineer?

AspectContractual Quality Engineer FdaContract Quality Engineer
CertificationsISO 13485, FDA regulations, GMPISO 13485, FDA regulations, GMP
Work EnvironmentMedical device manufacturing, regulated environmentsMedical device, pharmaceutical, or biotech industries
Employer UsageContract roles for FDA-regulated companiesContract roles across various industries including pharma and biotech
Search IntentCompare FDA-specific quality rolesBroader quality contract roles in regulated industries

The Contractual Quality Engineer Fda focuses specifically on FDA regulations and medical device compliance, often working in regulated environments. The Contract Quality Engineer has a broader scope, covering various industries like pharma and biotech, with similar certifications. Both roles require knowledge of FDA standards, but the Contractual Quality Engineer Fda emphasizes FDA-specific compliance in medical devices.

What are the most commonly searched types of Quality Engineer Fda jobs in Indiana?

The most popular types of Quality Engineer Fda jobs in Indiana are:

What cities in Indiana are hiring for Contractual Quality Engineer Fda jobs?

Cities in Indiana with the most Contractual Quality Engineer Fda job openings:

Quality Engineer 2, Manufacturing

Cook Group

Bloomington, IN • On-site

$80 - $100/hr

Other

Re-posted 27 days ago


Job description

Overview

The Quality Engineer at Cook Inc.serves as the lead quality representative of certain product lines within product development, m Next anufacturing, post-market surveillance, and/or CAPA.

Responsibilities
  • Perform work per external and internal quality standards
  • Interface with internal and external groups on quality-related issues
  • Support product development and transfer to manufacturing
  • Facilitate development and implementation of production controls (e.g. qualification, process capability, sampling plans, validation, etc.)
  • Perform investigation of product nonconformance/complaints, root cause analysis, monitoring/trending of process and product, and escalation of identified issues
  • Plan, review, and approve change requests
  • Execute risk assessment as needed and facilitate development and completion of risk file documentation
  • Conduct Risk-based decision making and effective resolution of issues
  • Lead or support CAPAs as necessary
  • May interface with internal or 3rd party audits (e.g. FDA, Notified Body, etc.)
  • Drive continuous improvement efforts through facilitating, leading, and collaborating with cross function teams including quality, engineering, production, clinical, and regulatory affairs.
  • Provide leadership in the understanding of medical device regulations and best practices
  • Manage conflict resolution as it relates to technical situations
  • Must work and interact effectively and professionally with and for others throughout various levels of the organization
  • Must strictly adhere to safety requirements
Qualifications
  • Bachelors degree in engineering
  • Demonstrates knowledge of medical device regulation (ISO 13485, 21CFR) and risk management (ISO 14971)
  • 3-5 years of experience
  • Professional certification (e.g. ASQ, Six Sigma, etc.) preferred
  • Proficiency in statistical, quality and continuous improvement methods and tools
  • Proficiency in the Microsoft Office suite of products (Word, Excel, PowerPoint, and Outlook) is required
  • Strong organizational skills
  • Critical thinking and attention to detail required
  • Excellent verbal communication skills and technical writing
Physical Requirements
  • Works under general office environmental conditions, including time in manufacturing environment and biohazard lab
  • Sitting for extended periods, utilizes close visual acuity for working with computers, equipment, etc.
  • Occasional travel may be required
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