Senior Quality Engineer

Marmon Holdings, Inc. • $90K — $120K *
Hillsboro, OR 97124In-Person
Pharmaceuticals & Biotech
5 - 7 years of experience
1 month ago
Job Overview by Ladders

Qualifications

  • Bachelor's degree in engineering or science; advanced degree preferred.
  • 5-8 years of quality assurance experience in a regulated environment, with a focus on implantable devices.
  • 3-5 years of familiarity with quality regulations and standards, including 21CFR 820 and ISO 13485.
  • Experience using CAPA and failure investigation methods.
  • Proficient in quality and statistical analysis tools such as SPC, FMEA, and trend analysis.
  • Strong communication skills for facilitating and negotiating solutions between departments.
  • Demonstrated teamwork and adaptability in fast-paced settings.
  • Knowledge of ERP Systems (SAP preferred) and proficiency in Microsoft Excel.

Responsibilities

  • Lead quality initiatives for new product development, focusing on design control and validation.
  • Guide engineering and manufacturing in verification planning and transferring activities.
  • Ensure project teams understand and comply with regulations and quality standards.
  • Provide training and interpret quality-related documents as needed.
  • Maintain the integrity of design history files and validation documentation.
  • Support ongoing quality engineering throughout the product life cycle, including CAPA investigations.
  • Manage non-conforming product notifications and ensure appropriate resolutions.

Benefits

  • Health, dental, and vision insurance.
  • 401(k) plan with company matching.
  • Professional development opportunities and training programs.
  • Flexible work hours and remote work options.
  • Paid time off and holiday leave.
Full Job Description
Job Scope

A Senior NPI Quality Engineer is responsible for quality planning and the overall quality of new products being released to the market. The Senior QE drives Quality objectives in product development activities, ensuring product and process conformance to global standards (including FDA and ISO 13485). The purpose of this position is to serve as a Quality leader during product development and manufacturing to ensure high product quality, reliability, and process capability and facilitate teams in identifying, documenting, assessing, correcting and presenting quality issues using risk analysis and root cause analysis tools.

Responsibilities
  • Provides quality leadership to new product development teams in the areas of design control, design verification and validation, design transfer, risk management, and specification development.
  • Provides leadership to development, engineering and manufacturing functions for verification/validation planning and transfer activities. Assists teams in determining validation needs and requirements.
  • Collaborates with project teams to ensure understanding of and compliance with regulations, procedures, and requirements.
  • Provides training, guidance and interpretation as needed.
  • Ensures quality and completeness of design history files, validation packages, and change orders.
  • Provides ongoing quality engineering support throughout the product life cycle, including CAPA investigations, and design changes.
  • Drives product risk management activities. Ensures identified activities and mitigations are executed as agreed.
  • Becomes familiar with the applicable technology to facilitate participation in technical discussions and risk-based decision making; coordinates issue resolution using a risk-based approach.
  • Manages Quality Notifications (Non-Conforming Material Requests) system and dispositions all non-conforming product.
  • Creates and maintains final inspection plans and works with applicable subject matter experts to develop and validate inspection methods, as needed.
  • Reviews verification and validation reports and identifies gaps for cGMP compliance.
  • Develops and executes strategies to close gaps in an efficient, technical, and compliant manner.
  • Provides expertise and guidance to end users and process owners with regard to data collection, analysis and creation of design verification and validation reports.
  • Ensures all design history file contents meet the requirements of FDA and ISO.
  • Trends and reports on quality data in order to improve product and process; develop recommendations based on data analysis.
  • Provides management with status updates on assigned responsibilities and goals and escalates issues in a timely manner.


Qualifications
  • Bachelors degree in engineering or science discipline; advanced degree preferred.
  • 5-8 years of experience in quality assurance in a regulated environment. Direct experience working with implantable devices preferred.
  • 3 - 5 years of experience applying quality regulations and standards (e.g. 21CFR 820, ISO 13485, ISO 14971, Medical Device Directive, etc.).
  • Experience with CAPA and failure investigation tools and techniques.
  • Knowledge of quality and statistical analysis tools (e.g. SPC, 6 Sigma, Risk Analysis, FMEA, DOE, trend analysis, etc.)
  • Highly effective communicator. Able to facilitate difficult conversations and negotiate solutions among different department representatives.
  • Proven track record of strong teamwork and delivering results. Adaptable to fast-paced, dynamic work environment with shifting demands.
  • Working knowledge of ERP Systems (SAP preferred) and Microsoft Office. Expert at Microsoft Excel.
  • ASQ Certified Quality Engineer preferred.
  • Understanding of and experience with GD&T preferred.


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.

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Industry
Manufacturing & Automotive
* Ladders Estimates

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