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Quality Engineer Medical Device
Quality Engineer Medical DeviceSelect Source International • Atlanta, GA, US
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Quality Engineer Medical Device

Quality Engineer Medical Device

Select Source International • Atlanta, GA, US
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Job Description

Job Description

Below Job Details :

Job Title : Sr. Product Quality Engineer

Duration : 12 Months

Location : Atlanta GA 30313

Description :

The Sr. Product Quality Engineer will serve as a technical representative providing design quality expertise to a product development team.

Responsible for maintaining a strong collaborative partnership with cross-functional team members to achieve patient / user safety, customer satisfaction, and organizational success.

This individual will be leading and managing a risk management team but could also work on other items.

Looking for someone well rounded from a development quality perspective.

Responsibilities

  • Lead and / or support on-time completion of Design Control deliverables.
  • Support the establishment of objective, measurable, and verifiable product requirements.
  • Support Design Verification and Validation planning & execution, including any cross-functional investigation & resolution activities.
  • Lead Risk Management activities from product concept through commercialization.
  • Support test method development and lead test method validation activities.
  • Support manufacturing process development & qualification for new product and design changes.
  • Support the establishment of component specification definitions, supplied component sampling plan development, and vendor qualifications.
  • Support biocompatibility and sterilization qualifications.
  • Support audits and quality system improvement activities.
  • Support Company initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and regulatory requirements.
  • Comply with U.S. FDA, EUMDR and other requirements, as applicable.
  • Maintain positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and suppliers.

Basic Qualifications :

  • Bachelor’s degree in engineering or Technical Field.
  • Minimum of 5 years of experience in R&D, Process / Manufacturing Engineering, and / or Quality with at least 2 years supporting product development.
  • Experience in medical devices and associated regulations / standards.
  • Experience in test method development and validation.
  • Experience in preparing risk assessments, FMEA and other risk documents.
  • Preferred Qualifications :

  • Advanced Degree in Engineering / Technical Field.
  • Experience in active implantable medical devices.
  • Knowledge of requirements management tools (e.g., DOORS) and use of problem reporting systems (e.g., JIRA).
  • Working knowledge of statistics and its application to verification and validation.
  • Company Description

    Select Source International (SSI) is a distinguished staffing company with nearly 25 years of experience, renowned for delivering top-tier workforce solutions encompassing staffing, recruiting, and managed services. As a proud supplier, we bring a wealth of expertise and best-in-business differentiators to comprehensively support your diverse workforce needs.

    Based in Minneapolis, Minnesota, USA, SSI has established itself as a global leader, serving a broad clientele across industries with unwavering dedication and excellence. SSI is ISO 9001, 14001, and Soc2 Type2 certified, underscoring our commitment to quality and security. We have garnered numerous sustainability and supplier diversity awards, further validating our industry-leading capabilities

    Company Description

    Select Source International (SSI) is a distinguished staffing company with nearly 25 years of experience, renowned for delivering top-tier workforce solutions encompassing staffing, recruiting, and managed services. As a proud supplier, we bring a wealth of expertise and best-in-business differentiators to comprehensively support your diverse workforce needs.\r\n\r\nBased in Minneapolis, Minnesota, USA, SSI has established itself as a global leader, serving a broad clientele across industries with unwavering dedication and excellence. SSI is ISO 9001, 14001, and Soc2 Type2 certified, underscoring our commitment to quality and security. We have garnered numerous sustainability and supplier diversity awards, further validating our industry-leading capabilities

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