Quality Engineer

ABOUT SYNOLUS MEDICAL

Synolus Medical is developing hands-free wearable injectors for high-volume subcutaneous drug delivery. This is a ground-floor opportunity to build quality systems, testing methodology, and DHF for an innovative combination product from concept through commercialization.

POSITION SUMMARY

Support the build-out of Synolus Medical’s Quality Management System and quality infrastructure, drive product testing and compliance, and embed quality into manufacturing scale-up across five core areas:

KEY RESPONSIBILITIES

QMS Framework & Infrastructure

• Support the design, build-out, and implementation of Synolus’s Quality Management System (QMS) from the ground up, ensuring full alignment with FDA QMSR and ISO 13485:2016 from day one
• Assist in defining the QMS architecture: process map, procedure hierarchy (Level 1 Quality Manual → Level 2 SOPs → Level 3 Work Instructions → Level 4 Records/Forms)
• Help establish and maintain core QMS subsystems: document control, training management, CAPA, nonconformance management, internal audits, management review, and supplier quality
• Support the selection, configuration, and validation of an electronic QMS (eQMS) platform (e.g., Greenlight Guru, MasterControl, or Veeva Vault) suited to a Class II combination product startup
• Assist in defining quality objectives, quality metrics (KPIs), and dashboard reporting for management review as required under ISO 13485:2016 § 5.6
• Participate in internal audit execution and gap assessments against 21 CFR Part 820, ISO 13485:2016, and ISO 11608-6:2022 requirements
• Support post-market surveillance (PMS) system setup including complaint handling, MDR/vigilance reporting procedures, and feedback loop processes per 21 CFR Part 803 and EU MDR 2017/745 Article 83

Quality Documentation

• Author, review, and maintain controlled quality documents including Quality Manual, SOPs, Work Instructions (WIs), test methods, forms, and templates across all QMS subsystems
• Manage the full document lifecycle in the document control system: initiation, review routing, approval, issuance, distribution, revision, and obsolescence per 21 CFR 820.40 and ISO 13485:2016 § 4.2
• Build and maintain the Design History File (DHF), Device Master Record (DMR), and Device History Record (DHR) for MiniGo™ in compliance with 21 CFR 820.181–820.184
• Develop and maintain quality plans for design, development, verification & validation, and manufacturing transfer phases of MiniGo™
• Create and maintain risk management documentation (Risk Management Plan, Risk Management Report, Hazard Analysis, DFMEA/PFMEA) per ISO 14971:2019
• Prepare and maintain the Technical File / Technical Documentation package supporting 510(k) submission and future EU MDR conformity assessment
• Ensure document version control integrity, traceability matrices, and change history are complete, accurate, and audit-ready always
• Support the creation and maintenance of the Unique Device Identification (UDI) documentation and labeling records per 21 CFR Part 830

Product Quality & Testing

• Write and execute V&V test protocols per ISO 11608-6:2022 (dose accuracy, activation force, adhesive attachment, delivery profile)
• Support DFMEA/PFMEA and risk management activities per ISO 14971:2019
• Conduct incoming inspection, in-process QC, and final device release
• Initiate NCRs, perform root cause analysis (5-Why, Ishikawa), and support CAPA closure

Regulatory Compliance (FDA / ISO)

• Maintain QMS documentation (SOPs, WIs, forms) per 21 CFR Part 820 and ISO 13485:2016
• Manage DHF, DMR, and DHR traceability; support 510(k) technical documentation
• Assist with combination product compliance under 21 CFR Part 4
• Support FDA inspections, internal audits, and Notified Body audit preparation

Manufacturing Scale-Up & Automated Operations

• Write and review IQ/OQ/PQ protocols for automated assembly and fill-finish equipment
• Support SPC, process capability analysis (Cpk), and sampling plan development
• Collaborate with manufacturing engineering on control plans during scale-up
• Assist in qualification of critical component suppliers (needles, adhesive patches, drug containers)

QUALIFICATIONS

Required

• B.S. in Biomedical, Mechanical, Chemical, or Industrial Engineering (or related field)
• 1–3 years in QA/QE in a regulated industry; medical device/pharma internship highly valued
• Foundational knowledge of 21 CFR Part 820, ISO 13485:2016, GMP/GDP principles
• Demonstrated ability to author clear, structured technical documents (SOPs, protocols, reports)
• Strong technical writing skills with high attention to detail; proficiency in Microsoft Office Suite

Preferred

• Familiarity with ISO 11608-6:2022 (on-body delivery systems) or ISO 14971:2019 (risk management)
• Exposure to QMS build-out, document hierarchy design, or eQMS platform implementation
• Experience with combination product regulation (21 CFR Part 4) or IEC 62366-1 (usability engineering)
• Experience with eQMS platforms (Greenlight Guru, MasterControl, Veeva Vault) or Minitab/SPC tools
• ASQ CQE certification (active pursuit considered a plus)

WHAT WE OFFER

• Competitive salary
• Ground-floor QMS ownership: build the quality system, not just maintain it
• Accelerated growth: exposure to regulatory submissions, combination product regulation & commercial scale-up
• Direct mentorship from experienced quality and regulatory leaders in drug delivery
• Equity participation opportunity

Pay: $60,000.00 - $90,000.00 per year

Education:

• Bachelor's (Required)

Location:

• Frederick, MD 21703 (Preferred)

Willingness to travel:

• 25% (Preferred)

Work Location: In person