Manufacturing Quality Engineer | InkSpace Imaging
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Manufacturing Quality Engineer

InkSpace Imaging is an award-winning medical device manufacturer specializing in lightweight and flexible MRI receive coils for Diagnostic Imaging and Multi-modality systems. Their body arrays allow radiologists to customize MRI experiences for individual patients, improving treatment outcomes and enhancing patient-centered care. The breakthroughs led by InkSpace Imaging are setting new standards in radiology, making them a leader in the field.


We are seeking a Manufacturing Quality Engineer to join our team at our electronics manufacturing facility in Pleasanton, in the Eastern San Francisco Bay area.

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In this role, a successful applicant will:
• Improve MRI coil manufacturing processes for PCBA and mechanical assembly.

  • Develop and sustain manufacturing processes in No-code Platform.

  • Lead Defect, CAPA, NCMR, FMEA, and Change Management activities.

  • Perform quality assessments as required by the QMS.

  • Participate in design reviews and provide expert technical quality input to identify and correct potential problems early in development, minimizing their impact on the broader project scope/ resources/ budget.

  • Author, review, and approve manufacturing documentation (e.g., for the product design history file).

  • Provide expert Quality input for proposed design and/or process changes. This includes ongoing identification of potential areas of improvement to improve the efficiency and outputs of processes related to products.

  • Author supplier quality agreements, advise on and support the adequate quality management of third parties and external manufacturers.

  • Ensure adequate supplier control plans are implemented, documented, and maintained.

  • Oversee supplier monitoring activities, and support supplier changes.

  • Conduct internal and supplier audits.

  • Contribute to Reporting and Management Reviews.

 

Preference will be given to candidates with the following:

  • 2+ years in the medical device industry, including experience focused on quality engineering-related activities

  • Working knowledge of relevant international ISO/IEC Standards (13485, 14971), regulations (2017/745 European Medical Device Regulation (MDR) s, 21 CFR - Part 820), and guidance.

  • Printed circuit board assembly experience

  • RF experience.

  • Strong interpersonal, influencing, analytical, and problem-solving skills with demonstrated ability to collaborate effectively across various internal/external stakeholders in demanding/ changing situations (medical, scientific, and production) to build trust, confidence, and collaboration toward shared objectives.

  • Strong communication skills, with the ability to get points across clearly and simply to all levels of the organization

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Inkspace Imaging offers a terrific work environment, professional development, and competitive 
compensation. We are an Equal Opportunity Employer. Our employment decisions are made without 
regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status or other characteristics protected by law.

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InkSpace Imaging only employs those legally authorized to work in the United States. Any offer of 
employment is conditioned upon the successful completion of a drug screen, past employment 
verification, and other applicable tests as required for the position. Unless expressly stated, relocation assistance is not provided.
 

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