Senior Quality Engineer

Marmon Holdings, Inc.•Hillsboro, OR

About The Position

Acumed LLC, a part of the global industrial organization Marmon Holdings (backed by Berkshire Hathaway), is committed to making a positive impact on the world by providing diverse learning and working opportunities and fostering a culture where everyone is empowered to be their best. The Senior NPI Quality Engineer is responsible for quality planning and the overall quality of new products being released to the market. This role 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 to facilitate teams in identifying, documenting, assessing, correcting, and presenting quality issues using risk analysis and root cause analysis tools.

Requirements

Bachelors degree in engineering or science discipline; advanced degree preferred.
5-8 years of experience in quality assurance in a regulated environment.
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.

Nice To Haves

Direct experience working with implantable devices preferred.
ASQ Certified Quality Engineer preferred.
Understanding of and experience with GD&T preferred.

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.