Quality Engineer Jobs

About The Position

Requirements

• Bachelor’s degree in Engineering, Materials Science, Biomedical Engineering, or a related technical discipline.
• At least 5 years of quality engineering experience in the medical device industry, primarily focused on supplier quality.
• Senior-level ownership of supplier quality programs; experience building or substantially improving supplier quality processes.
• Hands-on experience with hardware or electromechanical medical device components and manufacturing processes, such as machined parts, molded components, electromechanical assemblies, or sterile packaging.
• Experience conducting supplier audits against ISO 13485 and FDA QSR requirements and managing Supplier Corrective Action Requests.
• Proficiency with FMEA, SPC, 8D, root cause analysis, and sampling plans.
• Familiarity with FDA 21 CFR Part 820, ISO 13485, ISO 14971, and applicable standards.
• Ability to independently manage supplier relationships, including performance discussions, corrective actions, and escalations.
• Strong technical writing skills and ability to create clear, audit-ready quality documentation, including SOPs, work instructions, and qualification reports.
• Proficiency with eQMS platforms and standard office and data tools.
• Excellent verbal and written communication skills, including the ability to explain complex quality issues clearly and concisely.
• Self-directed, detail-oriented, highly organized, and proactive, with the ability to identify issues, develop practical solutions, and drive them to closure.
• Collaborative approach and willingness to contribute to broader quality responsibilities in a small, cross-functional team.
• High integrity and commitment to patient safety.
• Travel to supplier sites as required; estimated at 20–30%.

Nice To Haves

• Advanced degree in a relevant technical discipline.
• ASQ Certified Quality Engineer (CQE), Certified Quality Auditor (CQA), or equivalent certification.
• Experience supporting or leading first-product commercialization in a medical device startup or small-company environment.
• Experience building or significantly improving a supplier quality program from the ground up, ideally in a small- to mid-size medical device company.
• Exposure to internal audits, CAPA, and nonconformance management.
• Experience with eQMS platforms such as Greenlight Guru, MasterControl, or Veeva Vault.

Responsibilities

• Lead qualification and onboarding of suppliers, including developing and executing Supplier Qualification Plans and conducting associated audits.
• Assess supplier quality systems, manufacturing capabilities, and risk profiles through desk assessments, on-site audits, and technical reviews.
• Maintain the Approved Supplier List and ensure supplier files are current and compliant with QMS requirements.
• Work with Procurement and R&D to identify, evaluate, and qualify suppliers for new products and design changes.
• Develop and maintain incoming quality control processes, inspection plans, and acceptance criteria for purchased components and materials.
• Review and approve First Article Inspection Reports, Certificates of Conformance, and material and dimensional data packages.
• Resolve incoming inspection failures and nonconforming material with suppliers in a timely, documented manner.
• Support implementation and validation of appropriate statistical sampling plans, including ANSI/ASQ Z1.4 and Z1.9.
• Establish supplier scorecards and KPIs for quality, delivery, and responsiveness; conduct periodic performance reviews and communicate findings to stakeholders.
• Lead Supplier Corrective Action Request processes and work with suppliers on root cause analysis and corrective and preventive actions.
• Escalate chronic supplier performance issues and recommend re-qualification, resource changes, or supplier transitions.
• Ensure supplier quality activities comply with FDA 21 CFR Part 820, ISO 13485, and applicable international standards.
• Author, review, and maintain supplier quality procedures, work instructions, and records in the QMS.
• Support internal and external audits, including FDA inspections and Notified Body audits, by providing supplier quality documentation and evidence.
• Participate in Management Review and Quality meetings as a supplier quality subject matter expert.
• Contribute to internal audits, nonconformance investigations, CAPA, and QMS maintenance and improvement activities as business needs require.
• Provide quality engineering input to design control, risk management, design transfer, product risk assessments, and FMEAs.
• Partner with R&D on supplier-related design inputs, specifications, and drawing requirements to ensure manufacturability and quality at source.
• Support Manufacturing Operations in resolving supply chain disruptions, material shortages, and nonconformance events.
• Drive continuous improvement initiatives in the supplier base and internal receiving and inspection processes.
• Apply quality tools such as 8D, Fishbone/Ishikawa, 5-Why, FMEA, and SPC to solve supplier quality problems.
• Benchmark supplier quality practices and recommend enhancements as the company grows.
• Travel to supplier sites as required for audits, qualification activities, and quality issue resolution.
• Perform duties in compliance with Zenflow’s QMS and applicable regulatory requirements.

Benefits

• Comprehensive benefits
• Equity