Senior Quality Engineer

Precision Neuroscience•Addison, TX

4d•Onsite

About The Position

Precision Neuroscience is seeking a Senior Quality Engineer to lead production quality for the microfabrication of their Class III brain-computer interface implant at their microfabrication and device-assembly facility in Addison, Texas. This role involves providing technical quality oversight to ensure production compliance and capability, leading nonconformance and CAPA processes, and managing process and equipment validation and change control for the front-end MEMS microfabrication line, extending into back-end device assembly. The Senior Quality Engineer will also be responsible for assessing, maturing, and continuously improving the site’s quality processes in alignment with Precision’s quality management system and FDA QMSR (21 CFR Part 820). The position reports to the Sr. Quality Manager and collaborates with R&D–Microfabrication, Process Engineering, and Equipment Engineering. This role is based in Addison, TX, and remote work is not an option. The company is a fast-moving, well-capitalized entity in the brain-computer interface field, founded in 2021, with significant funding and ongoing human trials.

Requirements

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 knowledge of ISO 13485 and FDA QMSR (21 CFR Part 820), or a regulated-industry quality system (e.g., ISO 9001 or equivalent) with the ability to apply it to medical device.
Demonstrated ability to build, improve, and author quality processes and SOPs with senior individual-contributor autonomy.
Excellent interpersonal, written, and verbal communication skills.
Must be currently based in the US and legally authorized to work in the US.

Nice To Haves

Direct experience in medical device manufacturing (Class II or Class III) under FDA QSR/QMSR or ISO 13485.
Class III implantable or active implantable medical device (AIMD) manufacturing experience.
Working knowledge of front-end MEMS fabrication (photolithography, thin-film deposition, plasma etch) and/or back-end microelectronic device assembly (thermal compression bonding, dispense, laser dicing); contamination control and wafer-level test and inspection.
Computer System Validation (CSV) experience for production equipment software per GAMP 5 and/or 21 CFR Part 11.
Experience assessing, maturing, and continuously improving a quality management system and the validation program supporting it.
Working knowledge of risk management per ISO 14971, including design and process FMEAs.
Working knowledge of Lean, Six Sigma, or equivalent operational-excellence and structured problem-solving methods.
Quality-engineering knowledge equivalent to ASQ Certified Quality Engineer (CQE) or Certified Quality Auditor (CQA).
Experience supporting design transfer and new product introduction (NPI) from R&D to production.
Familiarity with electronic QMS (eQMS) and MES.

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 manufacturing line issues, focusing 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), required validation activities, 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.