AHEAD builds platforms for digital business. By weaving together advances in cloud infrastructure, automation and analytics, and software delivery, we help enterprises deliver on the promise of digital transformation.
At AHEAD, we prioritize creating a culture of belonging, where all perspectives and voices are represented, valued, respected, and heard. We create spaces to empower everyone to speak up, make change, and drive the culture at AHEAD.
We are an equal opportunity employer, and do not discriminate based on an individual's race, national origin, color, gender, gender identity, gender expression, sexual orientation, religion, age, disability, marital status, or any other protected characteristic under applicable law, whether actual or perceived.
We embrace all candidates that will contribute to the diversification and enrichment of ideas and perspectives at AHEAD.
The role focuses on collaborating with cross-functional teams to ensure customer satisfaction for both new and existing products. Key responsibilities include contributing to product design and development, reviewing Engineering Change Orders (ECO), managing risk through Failure Mode & Effects Analysis (FMEA), and analyzing quality data to recommend improvements. The role also involves investigating customer complaints, conducting quality audits, and facilitating continuous improvement through Kaizen events.
Key Responsibilities
- Collaborate with cross-functional teams to meet customer expectations for new and existing products
- Contribute to the design, development, and implementation of new products providing feedback to corrective and preventative actions to engineering, manufacturing, service and field operations and supplier performance
- Review and approve Engineering Change Orders (ECO) and support the material review board (MRB) processes as needed
- Conduct risk management activities in support of business decisions, including Failure Mode & Effects Analysis (FMEA) for new products
- Analyze quality data, identify problem areas, and recommend changes that lead to improvements
- Investigation and review of customer complaints, ensuring that root cause investigations are thorough and corrective / preventive actions are robust
- Conduct internal and vendor quality audits, per regulatory, customer, and QMS requirements
- Facilitate cross-functional Kaizen events to identify process risks and drive continuous improvement
Skills Required
- Working knowledge of ISO regulatory certifications 9001:2015, 13485:2016, and 14971:2019
- Knowledge of the code of federal regulations title 21 CFR 820 Quality System Regulations for Medical Devices
- Previous experience on certification of medical devices is a plus
- Ability to effectively interact with vendors, customers, and company management
- Strong organizational and multi-tasking skills to effectively prioritize and manage multiple projects
- Background in Manufacturing Engineering or Mechanical Engineering and familiarity with quality tools such as APQP, PFMEA, SPC, MSA, PPAP, SRR, and DOE are a plus
Why AHEAD:
Through our daily work and internal groups like Moving Women AHEAD and RISE AHEAD, we value and benefit from diversity of people, ideas, experience, and everything in between.
We fuel growth by stacking our office with top-notch technologies in a multi-million-dollar lab, by encouraging cross department training and development, sponsoring certifications and credentials for continued learning.
USA Employment Benefits include:
- Medical, Dental, and Vision Insurance
- 401(k)
- Paid company holidays
- Paid time off
- Paid parental and caregiver leave
