DescriptionPosition SummaryEmeraNova is seeking a motivated and innovative
Senior Quality Engineer to join our team. This is a sustaining-focused role supporting ongoing commercial manufacturing at our Mesa, AZ facility. You will own quality oversight of manufacturing equipment, lead quality event investigations, manage supplier quality and controls, and serve as the quality owner for our Manufacturing Execution System (MES). The ideal candidate is hands-on on the production floor, maintains ongoing compliance with FDA, ISO, and EU MDR requirements, and drives measurable improvement of the quality system through strong cross-functional partnership with Operations, Engineering, and Supply Chain.
Essential Functions- Serve as the primary quality representative for commercial manufacturing, partnering daily with Operations, Engineering, Maintenance, and Supply Chain to sustain product and process performance.
- Own quality oversight of manufacturing, inspection, and test equipment across its lifecycle - qualification (IQ/OQ/PQ), requalification, calibration and preventive maintenance programs, and assessment of equipment changes, repairs, and relocations for revalidation impact.
- Review and approve process validation protocols and reports for existing products and analyze validation data to confirm continued process capability.
- Lead and approve quality event investigations - nonconformances, deviations, CAPAs, and customer complaints - including root cause analysis and effectiveness verification.
- Disposition nonconforming product and material, and initiate internal containment, ship holds, and product holds for potential product escapes.
- Own supplier quality for the incoming material base, including supplier approval and monitoring, scorecards and periodic performance review, qualification and surveillance audits, and incoming inspection requirements.
- Lead supplier corrective action requests (SCARs) and failure analysis for component- and material-related issues, and qualify alternate or second-source components to mitigate supply chain risk.
- Serve as the quality owner of the Manufacturing Execution System (MES) day-to-day production support and issue triage, electronic batch record and configuration change control, and maintenance of the validated state under 21 CFR Part 11 and data integrity expectations.
- Review and approve change management activities for process, material, equipment, and document changes, including impact assessment and effectiveness verification.
- Conduct risk analyses (FMEA) and drive quality system improvement initiatives that maintain compliance with GMP, ISO 13485, FDA 21 CFR 820, FDA 21 CFR 1271, AATB, and EU MDR requirements.
- Trend quality event and post-market data, interpret quality KPIs, and translate findings into prioritized improvement actions and timely event closure.
- Author and revise SOPs, work instructions, and inspection criteria; support internal and external audits as a subject matter expert; and train manufacturing personnel on quality procedures and problem-solving tools.
This job description is not intended to be an exhaustive list of all duties, responsibilities, or
qualifications associated with the job. Other duties may be assigned.
Competencies•
Regulatory & Compliance Mastery: Applies advanced knowledge of FDA 21 CFR, ISO 13485, GMP, and applicable quality requirements to ensure ongoing compliance and audit readiness.
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Quality Systems & Documentation: Serves as a subject matter expert for quality system processes and ensures technical documentation and quality records meet internal, regulatory, and audit requirements
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Inspection, Auditing & Testing: Leads and supports internal, supplier, and quality audits; evaluates inspection and testing results; and drives resolution of identified quality issues.
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Process Improvement & Risk Management: Leads CAPA, NCR, root cause analysis, and risk-management activities while using quality data and trends to identify and implement systemic improvements.
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Training & Knowledge Sharing: Provides technical guidance and training to peers and cross-functional partners while mentoring junior team members on quality processes and best practices.
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Leadership & Strategic Oversight: Leads complex quality projects and cross-functional initiatives, influences quality-related decisions, and provides subject matter expertise without formal management responsibility.
Minimum QualificationsEducation:• Bachelor's degree in Biomedical, Mechanical, or a related engineering discipline
• MS in Biomedical or Mechanical Engineering preferred
Experience:• Minimum of 4 years of experience in a regulated manufacturing environment (tissue banking, biologics, pharmaceutical, or medical device), including direct support of commercial or sustaining manufacturing
- Hands-on experience with equipment qualification (IQ/OQ/PQ), calibration and preventive maintenance programs, and process validation
- Supplier quality experience, including supplier qualification, audits, SCARs, and incoming inspection requirements
- Working experience with a Manufacturing Execution System (MES), including electronic batch records and configuration change control
- Experience applying risk management and quality system improvement methods in a GMP manufacturing setting
• Experience with wound care or tissue-based (HCT/P) devices preferred
• Experience administering or configuring an MES platform in a validated environment preferred
• Experience hosting FDA, notified body, or AATB inspections preferred
• Background in design transfer and scale-up with contract manufacturers preferred
Certifications:• CQE, CQA, or equivalent ASQ certification preferred
• Six Sigma Green Belt or higher certification preferred
Knowledge, Skills, and Abilities- Strong knowledge of GMP, ISO 13485, FDA 21 CFR 820, FDA 21 CFR 1271, EU MDR, 21 CFR Part 11 and data integrity expectations, and risk management standards (e.g., ISO 14971)
• Strong analytical, problem-solving, and troubleshooting skills.
• Clear written and verbal communication, disciplined technical documentation practices, and proficiency with Microsoft Office.
• Strong attention to detail and commitment to quality.
• Able to prioritize multiple deliverables in a fast-paced environment, working independently and within cross-functional teams.
Physical Requirements• Ability to sit, stand, walk, bend, reach, and lift up to 25 pounds on an occasional basis.
• Ability to work in laboratory, manufacturing, and office environments.
• Frequent use of a computer and standard office equipment.
• Ability to wear required personal protective equipment (PPE) and comply with laboratory safety requirements.
Work EnvironmentEmployees in this role may be exposed to environmental, activity-related, and ergonomic hazards throughout the workday. Potential environmental risks include spills, weather-related conditions, inadequate ventilation, extreme heat or cold, poor housekeeping, chemical exposure, and slip, trip, or fall hazards. Activity-related hazards may involve working around heat sources, compressed gases, electrical cords and tools, energized equipment, and possible exposure to contagious diseases or other unforeseen risks. Ergonomic hazards may include lifting, awkward postures, repetitive motions, and prolonged periods of sitting or standing. Extended workstation use may contribute to back, shoulder, hand, or arm discomfort and eye strain, while prolonged standing may result in strains, sprains, or leg and knee discomfort. Employees must remain aware of workplace conditions, follow applicable safety procedures, promptly address or report hazards, and use required protective equipment to reduce the risk of injury.
Travel RequirementsAbility to travel up to 10% as needed.
What we offer:Looking for a company to work for can be a daunting task, but we believe that we stand out from the rest. Our company offers a positive and inclusive work environment, opportunities for growth and development, and a commitment to work-life balance. Join us and become part of a team that values your contributions and invests in your success.
