Quality Assurance Specialist

3 weeks ago

Fremont, California, United States THINK Surgical, Inc. Full time

Job Overview

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The Senior Quality Engineer at THINK Surgical, Inc. plays a pivotal role in ensuring the quality, safety, and reliability of our products. Reporting to the Quality Department, this individual will be responsible for leading the development, maintenance, and improvement of our standard practices while providing cross-functional support. This position is ideal for a seasoned professional with expertise in supplier, design, manufacturing, and software quality engineering.

About the Role

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  • Proactively investigate, identify, and implement best-in-class Quality Engineering practices.
  • Provide quality engineering expertise in supplier management, design control, manufacturing, software quality, and sterilization activities.
  • Lead quality engineering support and assume responsibility for timely and effective coordination and/or execution of assigned development project activities.
  • Act as an effective leader or team member in supporting quality disciplines, decisions, and practices.
  • Work with product development teams to develop measurable goals for quality.
  • Participate in the risk management process ensuring that hazards are adequately mitigated in product and process quality plans in accordance with THINK procedures and external standards (e.g. EN 14971).
  • Participate in Usability Engineering and planning documentation (e.g. EN 62366/ISO 62366).
  • Contribute in software documentation according to IEC62304, biocompatibility testing according to applicable regulations and standards including ISO10993, and EMC testing according to IEC60601-1.
  • Interface with other project team members and support the development effort for both product and packaging designs.
  • Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.
  • Assure in the development and execution of streamlined business systems which effectively identify and resolve quality issues.
  • Provide guidance to other engineers regarding applicable regulatory and statutory requirements and the applicability of these requirements to THINK Surgical products.
  • Support new product introduction projects through development and execution of process validation and verification test plans, protocols, and report.
  • Plan and direct creation of quality standards, quality control and quality assurance procedures, sampling plans, test methods, fixtures, and processes for finished devices manufactured at THINK Surgical.
  • Ensure process compliance through the design and development of quality plans, procedures including work instructions, flowcharts, forms, templates, checklist and other product or process related documentation, for recording, evaluating, and reporting quality data.
  • Support new product introduction projects through development and execution of process validation and verification test plans, protocols and reports.
  • Perform DHF/DHR/DMR reviews for product release.
  • Provide quality expertise post market release to the quality engineering support team to analyze the returned product.
  • Perform technical failure analysis based on the physics of failure.
  • Mentor and guide junior engineers and other QA team members, fostering knowledge development in quality engineering practices.
  • Assist the Quality Department on an as-needed basis.

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