Product Development Quality Engineer III

Resonetics; Westborough (MA); On-site; USD 78,000 - 93,000; Full time

Job summary

Ein innovatives Unternehmen sucht einen erfahrenen Produktentwicklungs-Qualitätsingenieur, um die Qualität in der Medizintechnik zu gewährleisten. In dieser Rolle werden Sie für die Anwendung fortschrittlicher Qualitätsmethoden verantwortlich sein, um sicherzustellen, dass alle Produkte den höchsten Standards entsprechen. Sie werden die Möglichkeit haben, an spannenden Projekten zu arbeiten, die die Zukunft der Mikrofertigung gestalten. Wenn Sie eine Leidenschaft für Qualität und kontinuierliche Verbesserung haben, ist dies die perfekte Gelegenheit für Sie, in einem dynamischen und unterstützenden Umfeld zu wachsen.

Qualifications

• Mindestens 2 Jahre Erfahrung in einer Qualitätsingenieurrolle in der Medizintechnik.
• Erfahrung mit ISO 13485 und 21 CFR 820.

Responsibilities

• Entwicklung und Implementierung von Risikomanagementstrategien.
• Durchführung von Ursachenanalysen und Bewertung von Korrekturmaßnahmen.
• Mentoring von Teammitgliedern in technischen Fähigkeiten.

Skills

Qualitätsdokumentation erstellen

ISO 13485

Statistische Software (z.B. Minitab)

Technisches Schreiben

Kommunikationsfähigkeiten

Education

Bachelorabschluss oder gleichwertige Erfahrung

Job description

Product Development Quality Engineer III

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Overview

Resonetics is a global leader in advanced engineering, prototyping, product development, and micro manufacturing, driving innovation in the medical device industry. With rapid expansion across all our locations, we continue to push the boundaries of technology while fostering a dynamic, employee-centered culture. Our commitment to excellence and continuous improvement makes Resonetics an exciting place for professionals passionate about shaping the future of micro-manufacturing and being part of something bigger.

The Product Development Quality Engineer III applies advanced Quality Engineering and scientific methods to daily tasks; adheres to relevant regulations, standards, and industry best practices; and manages projects with moderate to high technical responsibility. Acts as a subject matter expert in routine Quality Engineering and scientific matters, with guidance from technical Quality leaders.

Responsibilities

• Apply tools and methods for new product/process introductions and business improvements.
• Develop and implement risk management and mitigation strategies.
• Conduct root cause investigations and assess corrective actions.
• Develop test methods for equipment, process, and product validation.
• Maintain process Quality control plans based on product utilization and risk levels.
• Implement process controls using statistical techniques.
• Support design controls per ISO 13485:2016 and 21 CFR 820, and other regulatory requirements.
• Participate in design/technical reviews and lead Quality Engineering efforts in product development.
• Interpret and apply sampling plans; serve as SME in at least two quality areas.
• Collaborate with technical leaders to identify opportunities for quality improvements.
• Mentor team members in technical capabilities.
• Coordinate with customer quality teams to resolve issues and complaints.
• Generate process deviations, change notices, validation protocols, and reports.
• Assist troubleshooting and development of manufacturing processes and metrology equipment.
• Develop and maintain quality/control plans and ensure compliance with QMS and standards.
• Develop risk documentation, conduct Gage R&R studies, and resolve CAPAs.
• Create and deliver training on quality procedures.
• Support equipment calibration, maintenance, and product/process validation activities.
• Lead documentation efforts for design history files and device master records.

Qualifications

• Experience creating quality documentation and familiarity with ISO 13485 and 21 CFR 820.
• Minimum 2 years in a Quality Engineering role within medical device manufacturing or equivalent.
• Strong technical writing and communication skills.
• Knowledge of statistical software (e.g., Minitab).
• Bachelor’s degree or equivalent experience.
• Professional interaction with customers and suppliers, including auditing and qualification of new suppliers.

Compensation

Competitive salary based on experience, ranging from $78,000 to $93,000.