Medical Engineering Consultants (MEC)

Principal Quality Management Systems Engineer

BROOKLYN PARK, MNPosted 22 days ago

Job summary

  • Job post source

    This job is directly from Medical Engineering Consultants (MEC)

  • Job overview

    The Principal Quality Management Systems Engineer at MEC leads quality system documentation and continuous improvement efforts to ensure compliance and best practices in medical device and pharmaceutical projects.

  • Responsibilities and impact

    The role involves supporting project teams in QMS SOP adherence, managing risk analysis, coordinating FMEA development, assisting design and manufacturing quality engineers, coaching on quality topics, reviewing design verification and validation, managing corrective actions, participating in audits, and ensuring compliance with quality standards and documentation.

  • Experience and skills

    Requires 10 years of medical device experience with 5-7 years in quality and 5 years in QMS development, knowledge of ISO 13485 and FDA QSR, strong problem-solving, communication, and coaching skills, and a Bachelor's degree in a STEM field; MBA preferred.

  • Work environment and culture

    MEC promotes positive cultural change, exceeding client expectations, and offers a supportive environment with a focus on proactive and sustainable quality solutions.

  • Company information

    Medical Engineering Consultants (MEC) supports medical device and pharmaceutical companies by providing expert resources to improve efficiency, compliance, and quality systems.

  • Unique job features

    The position involves working closely with clients to implement sustainable quality solutions and offers opportunities to coach and develop personnel across multiple disciplines.

Company overview

Medical Engineering Consultants (MEC) is a specialized firm that provides expert consulting services in the medical engineering sector. They focus on offering solutions and guidance for the development and optimization of medical devices and technologies. MEC generates revenue by partnering with healthcare companies, research institutions, and manufacturers to enhance product design, ensure regulatory compliance, and improve operational efficiencies. The company has a history of innovation and collaboration, playing a crucial role in advancing medical technology. Candidates should be aware of MEC's commitment to quality and its reputation for driving impactful advancements in the healthcare industry.

How to land this job

  • Tailor your resume to emphasize your extensive experience in quality management systems, especially your skills in developing, implementing, and maintaining QMS policies aligned with ISO 13485 and FDA QSR requirements.

  • Highlight your expertise in risk management, including proficiency with ISO 14971, FMEA coordination, and coaching design and manufacturing quality engineers on risk and validation processes.

  • Showcase your ability to lead quality engineering support through all stages of product development, design verification, validation, and manufacturing transfer, ensuring compliance and continuous improvement.

  • Apply through multiple platforms such as Medical Engineering Consultants' official website and LinkedIn to maximize your application visibility and follow up on your application status.

  • Connect with current MEC employees in quality management or engineering roles on LinkedIn; use ice breakers like commenting on MEC’s commitment to proactive quality improvement or asking for advice on succeeding in their QMS environment.

  • Optimize your resume for ATS by integrating keywords from the job description like 'QMS development,' 'ISO 13485,' 'FDA QSR,' 'risk management,' 'design controls,' and 'corrective action' to ensure it passes automated screenings effectively.

  • Use Jennie Johnson's Power Apply feature to automate tailored resume customization, identify the best application channels, and uncover relevant LinkedIn contacts, allowing you to focus your time on preparing for interviews and networking.

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