Senior NPI Quality Engineer

Acumed LLC

As a part of the global industrial organization Marmon Holdings—which is backed by Berkshire Hathaway—you’ll be doing things that matter, leading at every level, and winning a better way. We’re committed to making a positive impact on the world, providing you with diverse learning and working opportunities, and fostering a culture where everyone’s empowered to be their best.

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 and reliability, and facilitate teams in identifying, documenting, assessing, correcting, and presenting quality issues using risk analysis and root cause analysis tools.  Responsibilities below require little supervision to prioritize and manage.

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 ensuring compliance with Acumed policies and global regulations, including FDA Quality System Regulation and ISO 13485.
• Provides leadership to development, engineering and manufacturing functions for verification/validation planning and design 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 and engineering change orders, including adherence to FDA & ISO requirements
• Provides ongoing quality engineering support throughout the product life cycle, including CAPA investigations, Health Hazard Evaluations, Risk Management, 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 Non-Conforming Material Reports and non-conforming product dispositions for all new and recently launched products.
• Creates and maintains final inspection plans and works with applicable subject matter experts to develop and validate inspection methods, as needed.
• Coordinates and communicates with external suppliers to facilitate the execution of Design Transfer Quality deliverables for new products.
• Reviews verification and validation protocols and reports and identifies gaps for cGMP compliance. Supports the development and execution of strategies to close gaps in an efficient, technical, and compliant manner.
• Provides management with status updates on assigned responsibilities and goals and escalates issues in a timely manner.
• Provides expertise and guidance with regard to data collection, analysis and creation of design verification and validation reports.
• Engages in continuous improvement activities by identifying opportunities and recommending improvements to design and development processes.  Leads the execution of recommended changes, as appropriate.
• Trends and reports on quality data in order to improve product and process; develop recommendations based on data analysis.

Qualifications

• Bachelor’s degree in an engineering or science discipline (advanced degree preferred) and minimum 5 years of experience in quality assurance in a regulated environment
• Direct experience working with implantable devices preferred
• Minimum 3 years of experience applying quality regulations and standards (e.g., 21CFR 820, ISO 13485, ISO 14971, Medical Device Directive, EU Medical Device Regulation, etc.)
• Experience with CAPA and failure investigation / root cause analysis tools and techniques
• Strong technical writing skills
• Proficient in quality and statistical analysis tools (e.g., 6 Sigma, Risk Analysis, FMEA, DOE, Hypothesis Tests, 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 MS Office, expert at Excel and experience with Minitab
• Experience with GD&T
• ASQ Certified Quality Engineer 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 [email protected], and please be sure to include the title and the location of the position for which you are applying.