Katalyst Healthcares and Life Sciences
Responsibilities:
- The Quality Engineer is responsible for maintaining quality and control of manufacturing processes and post-market performance of medical devices.
- Responsibilities include collaborating with internal and external stakeholders to achieve company objectives, leading technical root cause investigations, developing and executing risk-based decisions, resolving and documenting customer complaint and manufacturing investigations, and representing Quality in cross-functional projects.
- Develops and executes plans for quality and control to ensure manufacturing continuity and product conformance.
- Leads investigations into production and customer-facing quality issues to identify root cause, implement corrective and preventative actions, and monitor effectiveness.
- Monitors and analyses product performance of medical devices using a statistical and risk-based approach. Considers any quality, compliance, customer, and business risks.
- Performs hands-on troubleshooting of customer returned devices and manufacturing nonconformities and completes associated technical documentation.
- Develops tools to communicate complex technical problems and solutions to a variety of audiences within the organization.
- Proficient in project management, data analysis, root cause analysis, communication, and risk determination.
- Ensure compliance with the company's Quality System policies and procedures and applicable external requirements and standards, including FDA, ISO 13485, and other worldwide regulatory agencies as pertaining to medical devices.
- Highly preferred to have minimum of 1 year of working experience at a company (internships count).
- Experience in quality, or process engineering in a medical device company.
- Motivated, agile, communication.
- Bachelor's degree in Engineering.
- Minimum 1 years of relevant experience in a regulated industry (FDA environment preferred).
- Knowledgeable of FDA regulations, 21 CFR part 820 and Part 803 and ISO 13485 standard.
- Based on recent need at the site, Alcon will be expanding out a 2nd shift that will need quality support. The overall hours of 2nd shift for production is 2:30pm-12pm. The QE support role in terms of hours has some flexibility in that it could be a mid-shift role like 1-9pm. Additionally, this may not be every single day, but there's room to negotiate doing this schedule a few times a week, or one week on, one week off. The exact details have not been ironed out, but the Hiring Manager needs to get a head start in identifying those that are interested or can do it.
- The candidates that would be interested in this schedule will have a better chance of getting this position. What that will realistically look like is they will work normal business hours (8-5pm) for a period of time (potentially a few weeks), then potentially transition into a mid to 2nd shift once their mentor determines them to be independent enough.