Senior Quality Engineer l Medical Device Manufacturing

Michael Page; Valley View (OH); Vor Ort; USD 117.000 - 143.000; Vollzeit

Benefits dieser Stelle

Medical

Vision

More!

Zusammenfassung

Michael Page seeks a Quality Engineer to support medical device manufacturing, ensuring FDA and ISO 13485 compliance. You will lead CAPA, risk assessments, and cross-functional efforts to drive product quality and patient safety.

The role emphasizes supplier qualification, Design Control collaboration, and process validation in a highly regulated environment. A strong engineering background and 5–7 years of relevant experience are preferred.

Qualifikationen

• Bachelor’s degree in an engineering discipline pertinent to medical devices.
• 5–7 years of experience in Manufacturing or Quality Engineering.
• Experience supporting FDA-regulated medical devices and ISO 13485.
• Knowledge of Design History Files, DHF/DMR/DHR and Design Control requirements.

Aufgaben

• Support the launch and ongoing manufacturing of medical devices with domestic contract manufacturers to meet quality, delivery, and performance objectives.
• Provide production support for existing product lines through supplier qualification and CAPA execution.
• Collaborate with Product Development to ensure Design Control compliance throughout the lifecycle.
• Contribute to Design for Manufacturability and reliability initiatives, and cost optimization.
• Lead root cause investigations and implement corrective actions to prevent recurrence.
• Develop and execute process validation and production qualification activities to meet regulatory standards.

Kenntnisse

Quality engineering

Root cause analysis

CAPA management

Cross-functional collaboration

Regulatory compliance

Process improvement

Project management

Ausbildung

Bachelor's degree in Mechanical Engineering

Bachelor's degree in Biomedical Engineering

Bachelor's degree in Materials Science

Tools

QMS (ISO 13485)

FDA QSR (21 CFR 820)

Jobbeschreibung

Quality Engineer with experience supporting medical device manufacturing operations, ensuring compliance with FDA, ISO 13485, and customer quality requirements through robust quality systems, risk management, and continuous improvement initiatives. Skilled in root cause analysis, validation activities, CAPA management, and cross-functional collaboration to drive product quality, regulatory compliance, and patient safety.

Our client is an innovative and growing medical device manufacturer dedicated to developing high-quality products that improve patient outcomes and support healthcare professionals around the world. Operating in a highly regulated environment, the organization is committed to maintaining the highest standards of quality, regulatory compliance, and continuous improvement while investing in advanced technologies and manufacturing capabilities.

The company has built a strong reputation for its collaborative culture, where employees are empowered to contribute ideas, solve complex challenges, and make a meaningful impact on both the business and the patients who rely on its products. With a growing product portfolio, a financially stable foundation, and a commitment to professional development, this organization offers an excellent opportunity for individuals seeking a rewarding career in the medical device industry.

Description

• Support the launch and ongoing manufacturing of medical devices by identifying, qualifying, and partnering with primarily domestic contract manufacturing suppliers to ensure quality, delivery, and performance objectives are achieved.
• Provide production support for existing product lines through supplier selection, supplier relationship management, and execution of corrective and preventive actions (CAPA).
• Collaborate with Product Development teams to provide quality and manufacturing expertise throughout the product development lifecycle while ensuring compliance with Design Control requirements.
• Contribute to product designs by supporting Design for Reliability (DFR), Design for Manufacturability (DFM), Design for Inspection (DFI), regulatory compliance, and cost optimization initiatives.
• Lead root cause investigations related to manufacturing issues, nonconformances, customer complaints, and field feedback, implementing effective corrective actions to prevent recurrence.
• Develop, coordinate, and execute process validation and production qualification activities to ensure manufacturing processes consistently meet quality and regulatory standards.
• Support strategic manufacturing initiatives, including the evaluation and implementation of new internal manufacturing capabilities and the potential transition of outsourced processes to in-house production.
• Design and execute testing protocols, validation studies, and product evaluations to verify functionality and demonstrate compliance with applicable regulatory and quality requirements.
• Prepare, maintain, and manage Design Control documentation, including design history files, risk management documentation, validation records, and other product development deliverables.
• Work cross-functionally with Engineering, Quality, Regulatory Affairs, Operations, and Supply Chain teams to drive product quality, process improvement, and operational excellence.
• Ensure compliance with FDA Quality System Regulations, ISO 13485 requirements, and internal quality management system procedures.
• Support continuous improvement initiatives focused on product quality, supplier performance, manufacturing efficiency, and customer satisfaction.

Profile

• Bachelor's degree in Mechanical Engineering, Biomedical Engineering, Materials Science, or a related engineering discipline.
• 5-7 years of experience in Manufacturing Engineering, Quality Engineering, or a closely related technical role.
• Prior experience within the medical device industry, including at least 3 years supporting FDA-regulated products, is highly preferred.
• Working knowledge of quality management systems and regulatory standards, including ISO 13485, ISO 9001, and FDA Quality System Regulations.
• Demonstrated success leading cross-functional projects from development through commercialization, including manufacturing implementation and ongoing production support.
• Strong project management skills with experience managing project schedules, deliverables, resources, and budget considerations.
• Understanding of Design History Files (DHF), Device Master Records (DMR), Device History Records (DHR), and associated design control documentation requirements.
• Proven ability to work effectively in a fast-paced, collaborative environment where flexibility, initiative, and teamwork are critical to success.
• Self-motivated professional with strong communication, organizational, and problem-solving abilities.
• Desire to play a key role within a growing organization where individual contributions have a direct impact on business and product success.

Job Offer

• Salary up to $130,000
• 15% Bonus
• Medical
• Vision
• More!
  

MPI does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity or expression, national origin, age, disability, veteran status, marital status, or based on an individual's status in any group or class protected by applicable federal, state or local law. MPI encourages applications from minorities, women, the disabled, protected veterans and all other qualified applicants.