Senior Quality Engineer

Acumed LLC

Position Title: Senior Quality Engineer

Company: Acumed LLC

Req : JR

Location: Hillsboro, OR

Time Type: Full time

Description:

As part of Marmon Holdings—a global industrial organization backed by Berkshire Hathaway—this role involves leading at every level and winning a better way. It focuses on quality planning and ensuring product and process conformance to global standards (including FDA and ISO 13485) during product development and manufacturing.

A Senior NPI Quality Engineer is responsible for quality planning and the overall quality of new products released to the market. The Senior QE drives quality objectives, ensuring conformance to global standards and facilitating teams in identifying, documenting, assessing, correcting, and presenting quality issues using risk analysis and root cause analysis tools.

• Provides quality leadership to new product development teams in design control, 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 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.
• Supports CAPA investigations and design changes throughout the product life cycle.
• Drives product risk management activities and ensures that identified activities and mitigations are executed.
• Familiarizes with applicable technology to facilitate participation in technical discussions and risk‑based decision making; coordinates issue resolution using a risk‑based approach.
• Manages Quality Notifications system and disposes all non‑conforming product.
• Creates and maintains final inspection plans and works with subject‑matter experts to develop and validate inspection methods.
• Reviews verification and validation reports to identify gaps for cGMP compliance.
• Develops and executes strategies to close gaps efficiently, technically and compli‑antly.
• Provides expertise and guidance to end users and process owners on data collection, analysis, and creation of design verification and validation reports.
• Ensures design history file contents meet FDA and ISO requirements.
• Trends and reports on quality data to improve product and process; develops recommendations based on data analysis.
• Provides management with status updates on assigned responsibilities and goals and escalates issues timely.

• Bachelor’s degree in engineering or science discipline; advanced degree preferred.
• 5‑8 years of experience in quality assurance in a regulated environment; direct experience with implantable devices preferred.
• 3‑5 years of experience applying quality regulations and standards (e.g. 21
  
  CFR 820, ISO 13485, ISO 14971, Medical Device Directive).
• Experience with CAPA and failure investigation tools and techniques.
• Knowledge of quality and statistical analysis tools (e.g. SPC, Six Sigma, Risk Analysis, FMEA, DOE, trend analysis).
• 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 a fast‑paced, dynamic work environment.
• 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.

We are an equal‑opportunity employer, and all applicants will be considered for employment without attention to their membership in any protected class. If you require any reasonable accommodation to complete your application or any part of the recruiting process, please email your request to , and be sure to include the title and the location of the position for which you are applying.

Acumed is an equal‑opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a protected veteran, or qualified disability.