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Senior Quality Reliability Engineer

Precision· Quality
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Addison, TX$120k - $150kFull-timePosted 3w ago

About the role

Senior Quality & Reliability Engineer to lead production quality for the microfabrication of a Class III brain–computer interface implant, ensure compliance with FDA QMSR (21 CFR Part 820), drive CAPA and change control, and continuously improve site quality processes at the Addison, TX facility.

Responsibilities

  • Serve as the quality engineering owner for assigned microfabrication lines, providing floor-level technical support, dispositioning quality issues, and defining the path to resolution.
  • Partner with Process Engineering and Equipment Engineering to contain and resolve line excursions, with a focus on maintaining production continuity.
  • Create and maintain compliant medical device files and production records for production builds.
  • Drive incoming, in-process, and final acceptance against documented specifications.
  • Apply advanced statistical and data analysis techniques to identify quality & reliability risks, understand failure mechanisms for continuous improvement.
  • Define qualification/validation strategies (IQ/OQ/PQ) for microfabrication and device-assembly processes and equipment in partnership with Process Engineering & Equipment Engineering.
  • Lead process risk evaluation & analysis per ISO 14971 (e.g., FMEA) and translate into MVP, validation activities, and process control plan.
  • Define and review test-method validation (TMV), including measurement-system analysis and gage R&R.
  • Support facilities qualification (IQ/OQ) in collaboration with Equipment and Facilities Engineering teams.
  • Lead nonconformance (NCMR) and MRB process with root-cause analysis, CAPA, and supplier corrective action (SCAR) support.
  • Manage quality & reliability aspects of change control, documenting rationale and aligning stakeholders; perform impact and reliability risk assessment.
  • Own and advance site validation program for production equipment, processes, and software (including CSV per GAMP 5 / 21 CFR Part 11).
  • Author QMS documents such as SOPs, work instructions, and forms/templates.
  • Partner with R&D–Microfabrication and Process Engineering on design transfer and production release for new and transferring programs; contribute to ISO 14971 FMEA for transfer programs.

Qualifications

  • BS in Engineering (Mechanical, Biomedical, Materials, Chemical, Industrial, or related) + 5–10 years of quality, reliability, or process engineering experience in regulated/high-reliability manufacturing; or MS in Engineering + 3–8 years of relevant experience.
  • Hands-on experience in a microfabrication, semiconductor fab, or comparable cleanroom manufacturing environment.
  • Experience in IQ/OQ/PQ or equivalent qualification/validation; MVP development.
  • Change control experience with impact and risk assessment driving requalification/revalidation.
  • Statistical methods including SPC, sampling plans, Cpk/Ppk, gage R&R, and DOE; ability to partner with process engineering on yield improvement and variation reduction.
  • NCMR/MRB, failure analysis, and CAPA ownership with structured root-cause analysis.
  • Working knowledge of ISO 13485 and FDA QMSR (21 CFR Part 820) or equivalent regulated quality system.
  • Ability to write and improve quality processes and SOPs with senior individual-contributor autonomy.
  • Excellent interpersonal, written, and verbal communication skills.

Skills

Required:Quality engineering ownershipStatistical methodsNCMR/MRB and CAPAIQ/OQ/PQ qualification/validationRegulatory quality systemsProcess/Equipment change controlDesign transfer / NPI support

Benefits

  • Diverse, inclusive culture (explicit commitment to inclusivity).
  • Equal opportunity employer.
Last updated Oct 7, 2026. Interested? Apply on the company site.

About Precision

The brain-computer interface that will change everything

Unlocking the full potential of the brain.

brain–computer interfaceneurotechnologyhealthcareneuroscience
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