Senior Quality Engineer

About Precision Neuroscience

Precision Neuroscience is building a next‑generation brain–computer interface (BCI) to heal and empower millions of people living with neurological conditions.

We are seeking a Senior Quality Engineer to lead production quality for the microfabrication of our Class III BCI implant at our facility in Addison, Texas.

• 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 manufacturing line issues, 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.

• Define quality requirements, review and approve equipment qualification (IQ/OQ) and process validation (MVP, OQ/PQ) for microfabrication and device‑assembly processes and equipment, executed in partnership with Equipment Engineering and Process Engineering.
• Lead process risk analysis per ISO 14971, translating risk into the master validation plan (MVP), the validation activities required, and the process control plan (including testing strategy).
• Define and review test‑method validation (TMV), including measurement‑system analysis and gage R&R.
• Support facilities qualification (IQ/OQ) in collaboration with the Equipment and Facilities Engineering teams.

• Lead the nonconformance (NCMR) and Material Review Board (MRB) process—investigation, disposition, and trending—with structured root‑cause analysis.
• Lead corrective and preventive actions (CAPA): root‑cause analysis, corrective action, effectiveness verification, and timely closure.
• Support supplier corrective action (SCAR) for material‑ and process‑related nonconformances.

• Manage the quality aspects of process and engineering change control, documenting technical quality rationale and aligning stakeholders across Process Engineering, Equipment Engineering, R&D–Microfabrication, and Regulatory.
• Perform change impact and risk assessment, identifying and driving follow‑on actions such as requalification or revalidation, including changes to process flows and recipes.

• Assess, mature, and continuously improve site quality processes in line with Precision’s quality management system and FDA QMSR (21 CFR Part 820).
• Own and advance the site validation program for production equipment, processes, and software (including Computer System Validation 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, including wafer‑level test and inspection and quality planning for new product introduction (NPI).
• Contribute to design risk management (ISO 14971, design FMEA) for transferring programs.

• BS in Engineering (Mechanical, Biomedical, Materials, Chemical, Industrial, or related) + 5–10 years of quality engineering experience in regulated or 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.
• Equipment and process qualification and validation (IQ/OQ/PQ or equivalent), authoring and execution.
• Process and engineering change control, including change impact and risk assessment driving requalification or revalidation.
• Statistical methods—SPC, sampling plans, process capability (Cpk), gage R&R, and design of experiments (DOE)—sufficient to support validation and partner with process engineering on yield and variation reduction.
• Nonconformance (NCMR/MRB) and CAPA ownership with structured root‑cause analysis.
• Working…