Quality Engineer 2

Marmon Holdings, Inc. • $75K — $95K *
Hillsboro, OR 97124In-Person
Healthcare
Less than 5 years of experience
Yesterday
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Job Overview by Ladders

Qualifications

  • Bachelor's degree in Engineering or Science with 2+ years of quality experience in a regulated environment, or 8+ years of equivalent experience.
  • Implantable medical device experience preferred.
  • Knowledge of FDA 21 CFR 820, ISO 13485, ISO 14971, MDR/MDD, and related regulations.
  • Experience with CAPA, root cause analysis, Six Sigma, and risk analysis.
  • Strong technical writing, communication, teamwork, and problem-solving skills.
  • Proficient in SAP/ERP, Microsoft Office (advanced Excel), Minitab, and GD&T.

Responsibilities

  • Represent Quality on new product development teams ensuring compliance with FDA, ISO, and company standards.
  • Support verification, validation, and design transfer activities in engineering and manufacturing.
  • Train cross-functional teams on quality regulations and procedures.
  • Ensure complete and compliant Design History Files and Engineering Change Orders.
  • Provide quality support throughout the product lifecycle, including CAPA and risk management.
  • Lead product risk management activities and ensure mitigation actions are completed.
  • Participate in technical discussions using risk-based decision making.

Benefits

  • Opportunities for personal and professional growth through training and development.
  • Collaborative team environment that values innovation and continuous improvement.
  • Engagement in meaningful work contributing to healthcare advancements.
Full Job Description
Acumed LLC

Job Scope
The NPI Quality Engineer II leads quality planning and ensures the quality of new products from development through market release. This role drives quality objectives during product development, ensuring compliance with FDA, ISO 13485, and other global standards. The QE II serves as the Quality lead during development and manufacturing, using risk management and root cause analysis to identify, assess, resolve, and communicate quality issues with limited supervision.

Responsibilities

  • Represent Quality on new product development teams for design control, verification/validation, design transfer, risk management, and specifications while ensuring compliance with FDA, ISO 13485, and company requirements.
  • Support engineering and manufacturing with verification, validation, and design transfer activities; define validation needs.
  • Train and guide cross-functional teams on quality regulations, procedures, and requirements.
  • Ensure complete, compliant Design History Files and Engineering Change Orders.
  • Provide quality support throughout the product lifecycle, including CAPA, Health Hazard Evaluations, risk management, and design changes.
  • Lead product risk management activities and ensure mitigation actions are completed.
  • Participate in technical discussions and issue resolution using risk-based decision making.
  • Process Non-Conforming Material Reports and disposition nonconforming products for new launches.
  • Develop and maintain final inspection plans; support validation of inspection methods.
  • Coordinate with suppliers on design transfer quality deliverables.
  • Review verification/validation protocols and reports for cGMP compliance and support gap closure.
  • Report progress, escalate issues, support data analysis, and prepare verification/validation reports.
  • Drive continuous improvement by identifying and implementing enhancements to design and development processes.

Qualifications

  • Bachelor's degree in Engineering or Science with 2+ years of quality experience in a regulated environment, or 8+ years of equivalent experience.
  • Implantable medical device experience preferred.
  • Knowledge of FDA 21 CFR 820, ISO 13485, ISO 14971, MDR/MDD, and related regulations.
  • Experience with CAPA, root cause analysis, Six Sigma, FMEA, DOE, risk analysis, statistical methods, and trend analysis.
  • Strong technical writing, communication, teamwork, and problem-solving skills.
  • Proficient with SAP/ERP, Microsoft Office (advanced Excel), Minitab, and GD&T.

Following receipt of a conditional offer of employment, candidates will be required to complete additional job-related screening processes as permitted or required by applicable law.

About Marmon Holdings, Inc.

Marmon Holdings, Inc. Careers

Joining Marmon Holdings, Inc. presents a prime opportunity to be part of a team that values innovation, leadership, and diversity. As a global industrial organization, Marmon Holdings, Inc. offers a variety of job opportunities that cater to professionals seeking growth and development in their careers.

Explore Job Opportunities

Marmon Holdings, Inc. is actively hiring and offers positions that challenge and reward their employees. With a commitment to professional growth, the company provides a platform where skills and leadership converge to create impactful results. Explore the current openings and find the position that aligns with your career aspirations.

Internship Programs

For those at the beginning of their professional journey, Marmon Holdings, Inc. offers robust internship programs. These opportunities are designed to cultivate skills through hands-on experience, providing a strong foundation for future employment in various industries within the company.

Culture and Benefits

Marmon Holdings, Inc. is renowned for its inclusive culture that embraces diversity and fosters innovation. Employees enjoy a range of benefits that support both their professional and personal lives, enhancing job satisfaction and team cohesion. The company's commitment to diversity training ensures a workplace where everyone’s contributions are valued.

Professional Growth and Development

Career advancement is a cornerstone of Marmon Holdings, Inc.'s ethos. Employees are encouraged to take leadership roles, participate in networking events, and engage in continuous learning through various development programs. This focus on professional enhancement allows individuals to excel and lead in their respective fields.

Networking and Innovation

At Marmon Holdings, Inc., networking is seen as a key component of career advancement. Employees are encouraged to connect with peers and leaders within the company to exchange ideas and foster innovation. This collaborative environment is integral to the company’s success and the personal growth of its team members.

Join the Marmon Holdings, Inc. Team

Start your journey with Marmon Holdings, Inc. by applying today. Tailor your resume to reflect your unique skills and experiences, and prepare for an interview that could lead to a multitude of rewarding career paths within the company.

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Learn more about Marmon Holdings, Inc.
Industry
Manufacturing & Automotive
* Ladders Estimates

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