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Scienceabode > Quality Control Engineer

Quality Control Engineer

Last updated: 2025/07/10 at 8:00 AM
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3 Min Read
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  • Permanent
  • United States
  • Posted 23 hours ago
KeyPoint Staffing

Website KeyPoint Staffing

KeyPoint Staffing

Company : KeyPoint Staffing

Opportunity for a Quality-Focused Engineer in Medical Manufacturing
Our client is currently hiring a Quality Assurance Engineer to join their growing operations in the medical device sector. This full-time role is perfect for a mid-level professional with 3 to 5 years of relevant experience who enjoys collaborating across teams and ensuring excellence in product quality, compliance, and manufacturing support.

This position plays a key role in maintaining high standards across the production and product development lifecycleensuring all activities meet applicable regulatory and internal quality standards.

What Youll Take Ownership Of:

  • Drive material review activities and help lead weekly meetings focused on nonconformance evaluation and resolution
  • Follow up on vendor quality issues and coordinate disposition efforts
  • Maintain calibration tracking systems to support precision in equipment usage
  • Work closely with manufacturing engineers to develop and update documentation such as build records, process flows, BOMs, and manufacturing instructions
  • Assist with transitioning new products from R&D into production environments
  • Perform component-level reviews for incoming materials to verify conformance
  • Write and update standard operating procedures, inspection criteria, and lab test methods
  • Ensure all documentation and activities align with applicable regulations and company policies
  • Support quality investigations involving customer complaints, internal deviations, and CAPA execution
  • Participate in internal audits and supplier performance evaluations
  • Apply structured problem-solving techniques to assess root causes and support corrective/preventive efforts
  • Use data-driven analysis to recommend and implement risk-based quality decisions

Who Were Looking For:

  • 3-5 years of hands-on quality experience in a regulated medical manufacturing environment
  • Solid understanding of FDA 21 CFR Part 820 and ISO 13485 standards
  • Prior experience executing and managing CAPA programs
  • Exposure to incoming inspection, cleanroom practices, and electro-mechanical or cable assembly preferred
  • Knowledge of validation protocols, including equipment, process, and test method validations (including Gage R&R)
  • Comfortable using Microsoft Office Suite; proficiency in Excel is especially important
  • Working familiarity with statistical analysis tools and methods; Minitab experience is a plus
  • Excellent technical writing skills for protocol development and formal reporting
  • Experience working in a start-up or early-phase company is a bonus

This Role Is a Fit If You:

  • Thrive in a collaborative team environment
  • Can manage multiple priorities with attention to detail
  • Enjoy troubleshooting and using data to guide decisions
  • Are driven to maintain the highest standards in product quality and compliance

If you're seeking a role where your input matters, your expertise is valued, and your impact is visible across the organization, we encourage you to apply.

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