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Pixium Vision S.A. · 3 months ago

Quality and Regulatory GMP Engineer

Alameda, CA

Contract

Onsite

Mid Level

$115K/yr - $175K/yr

3+ years exp

Pixium Vision S.A. is a clinical stage, vertically integrated technology company focused on solving some of neuroscience’s hardest questions and unmet medical needs. The QARA GMP Engineer will lead cross-functional project teams to drive regulatory milestones and ensure compliance while managing the Quality Management System and supporting product development timelines.

Clinical TrialsHealth CareInformation TechnologyMedical DeviceSoftware

Responsibilities

Lead cross-functional project teams to drive regulatory milestones, accelerate product development timelines, and ensure timely product launches while maintaining compliance standards

Champion a flexible, risk-based approach to Quality and Regulatory compliance, coordinating sprint planning, backlog prioritization, and cross-functional meetings to keep projects on schedule

Drive manufacturing sections of regulatory submissions (DMR, manufacturing process descriptions, facility information)

Interface with FDA and other regulatory bodies on GMP inspection readiness and responses

Collaborate in establishing and optimizing Good Manufacturing Practices (GMP) environments for diverse production needs (e.g. ISO Class 5-7 cleanrooms, cell culture processing facilities, and protein engineering), including establishment of environmental monitoring programs and contamination control strategies; implement Good Tissue Practices (GTP) where applicable

Establish quality agreements with contract manufacturers handling specialized processes as needed

Design and validate manufacturing processes for Class II-III medical devices and biologics, including validation of cleaning, sterilization, and bioburden control procedures

Manage multiple manufacturing projects across different product lines and technologies

Lead technology transfer from R&D to manufacturing, with an eye for scalability, guiding staff on design for manufacturing principles

Coordinate design reviews, verification/validation testing, and change-control justifications; ensure critical parameters are documented, justified, and tested prior to implementation

Serve as quality representative on material review board

Manage equipment calibration, qualification, and preventive maintenance schedules. Troubleshoot equipment issues and coordinate repairs with vendors

Conduct product release inspections, managing quality control processes, and collaborating with production teams

Perform inspection and testing of purchased materials, components and products in accordance with policy and procedures

Contribute to materiovigilance activities, field corrective actions, and recall readiness

Work cross-functionally to identify, root cause, and resolve quality issues (e.g. nonconforming product); implement corrective and preventative actions

Own supplier qualification for specialized materials including biological reagents, cell culture components, and semiconductor-grade materials

Prepare and review regulatory submissions (Technical Files, UKCA dossiers, PMA/Supplements, IDE, 510(k)) across multiple product portfolios simultaneously; interface with notified bodies and regulators to address questions and obtain clearances/approvals

Own creation and maintenance of comprehensive Risk Management Files (ISO 14971) for diverse product lines with varying regulatory pathways; author risk control packages and drive timely implementation of mitigations from design through post-market surveillance

Support global registrations, inspections, and surveillance audits; compile objective evidence, facilitate on-site interactions, and drive timely response to findings

Assist in maintaining and enhancing the QMS to ensure efficient compliance with ISO 13485, MDR 2017/745, FDA: 21 CFR Part 820 and other applicable regulations

Create training programs for manufacturing personnel; ensure employees are trained to perform their work and that their training is documented

Support GLP and GCP activities when manufacturing provides test articles or clinical supplies

Identify opportunities to optimize quality processes and reduce regulatory burden while maintaining compliance. Lead continuous improvement initiatives to reduce cycle times and eliminate redundancies

Establish and track manufacturing KPIs, yield improvements, and cost reduction initiatives for management reviews

Qualification

GMP experienceFDA regulationsProcess validationProject managementQuality Management SystemMedical device manufacturingBiologics productionCommunication skillsProblem-solving skillsAttention to detailOrganizational skills

Required

Engineering Degree or equivalent in quality, regulatory and/or life sciences

Minimum 3 years of progressive GMP experience in medical device and/or biologics manufacturing

Strong understanding of FDA 21 CFR 820, 211, 1271 and EU GMP guidelines

Experience with wafer production and medical device assembly manufacturing processes (e.g. batch release)

Experience with process validation (IQ/OQ/PQ) for both equipment and manufacturing processes

Knowledge of cell culture, aseptic processing, and biological manufacturing controls

Proven project management skills with ability to drive regulatory submissions

Excellent communication skills with ability to work across diverse technical teams

Strong problem-solving capabilities and attention to detail

Demonstrated success managing parallel projects in a fast-paced environment, balancing compliance rigor with agile execution to meet aggressive timelines

Detail-oriented with strong organizational and problem-solving skills

Ability to interpret standards and regulations into actionable requirements and documentation needs across varied technologies

Ability to travel (domestic and international; to various company locations and third-party sites)

Preferred

Experience with implantable medical devices, Class II-III medical devices, biologics, or combination products

Demonstrated expertise in cleanroom design and operations (ISO 14644)

Knowledge of Good Tissue Practices (21 CFR 1271) and cellular therapy manufacturing

Strong knowledge of global medical device regulations, particularly MDR 2017/745, 21 CFR Part 820, Good Manufacturing Practices, ISO 9001, ISO 13485, ISO 14971, ISO 62366

Trained in internal and supplier audits

Experience with regulatory inspections and audit management (e.g. FDA, Notified Body)

Knowledge of multiple medical device regulation areas

Experience managing quality and regulatory activities across multiple product lines simultaneously

Working knowledge across multiple GxP disciplines (GLP, GCP) with ability to provide cross-functional support and adapt to different regulatory environments as business needs require

Proficiency with electronic QMS, PLM, CMMS, and project-management tools (e.g., Asana)