Quality Engineer - Only -W2 - Medical Device

Danvers, MA, US

7 days ago
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Summary

Job Title: Quality Engineer II

Location: Brooklyn Center, Minnesota

Position Summary

As a Quality Engineer II, you will play a key role in developing, implementing, and maintaining quality standards for materials, processes, and products. You will collaborate with engineering, manufacturing, and cross-functional teams to ensure products meet required specifications and compliance standards. This role involves both hands-on and strategic quality assurance activities, including process improvement, testing, inspection, and data analysis.

Key Responsibilities

  • Develop, revise, and maintain quality standards and protocols for materials, components, and finished products.
  • Collaborate with engineering and manufacturing teams to integrate quality standards throughout the production process.
  • Design and implement testing and inspection methods for evaluating the accuracy and precision of products and equipment.
  • Conduct quality assurance tests and perform statistical analysis to assess product reliability and identify areas for improvement.
  • Investigate product or process deviations and recommend corrective and preventive actions to ensure conformance to quality standards.
  • Ensure all quality documentation and processes are compliant with internal and external regulatory requirements.
  • May focus on quality in specific areas such as design, incoming materials, production control, product evaluation, reliability, inventory control, or R&D.

Career Stream: Specialist

This position is part of the Specialist Career Stream, typically as an individual contributor with expertise in a specific discipline. You will be responsible for delivering and managing moderately complex projects from conception through implementation. You may mentor junior colleagues or provide guidance to support staff.

Role Characteristics

  • Autonomy: Operates independently on moderately complex assignments, under general supervision.
  • Organizational Impact: Contributes to achieving team and project goals by setting objectives and ensuring milestones are met.
  • Problem Solving: Resolves routine issues and contributes ideas for improving systems, processes, or procedures.
  • Communication: Interacts primarily with internal stakeholders to exchange information, gather input, and support decision-making.
  • Leadership: May guide or mentor less experienced team members or support personnel.

Qualifications

  • Bachelor’s degree in Engineering, Quality, or a related technical field.
  • Minimum of 2 years of relevant professional experience, or an advanced degree with no prior experience.
  • Practical understanding of quality systems, regulatory requirements, and industry best practices.
  • Strong analytical and problem-solving skills with the ability to interpret and apply statistical data.
  • Effective communication skills for cross-functional collaboration.

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