Quality and Regulatory GMP Engineer

Science Corporation•Alameda, CA

43d•$115,000 - $175,000

About The Position

The QARA GMP Engineer will serve as the manufacturing and production expert within our Quality and Regulatory Affairs team, where each team member brings both quality and regulatory knowledge but specializes in a specific domain. This unique role requires knowledge spanning traditional medical device manufacturing and biologics production to support our innovative product lines. While production focused, this position requires the ability to flex into other GxP activities as needed, drive regulatory submissions, lead complex projects from concept through commercialization, and assist in evolving and maintaining the Quality Management System (QMS). This position blends quality, regulatory, and project management expertise with agile methodologies to accelerate time-to-market while safeguarding patient safety and regulatory compliance.

Requirements

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).

Nice To Haves

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)

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