Job Description
Job DescriptionResponsibilities:
- 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.
Requirements:
- 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.
Work Schedule:
- 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.