What are the responsibilities and job description for the Quality, Manufacturing Operations position at Katalyst CRO?
Responsibilities
- Demonstrate an understanding and functional impact of changes to critical dimensions of components.
- Lead non-conformance containment, remedial action, and root cause investigation. Participate in disposition of non-conformances, track and trend in UAI, rework and scrap.
- On a limited basis, must have the ability to process, and where appropriate, investigate routine Medical Device customer feedback (complaints) in a high paced, efficient and accurate manner.
- Must be able to apply a well-rounded understanding of engineering/design specifications, and engineering principles and methods, to perform engineering analysis and resolve engineering problems of moderate complexity.
- Write effective reports and do so in a timely, priority driven manner, working effectively in a team environment with shifting priorities and time sensitive requirements.
- Establish and maintain communication both internal and external (with the customers, molding, automation, assembly, product engineering, project management and regulatory personnel as needed).
- Create and review Control Plans, PFMEA's, 8Ds, CARs, APQP documentation, PPAPs.
- Improve Quality System through internal audits and compliance audits.
- Actively participate in correction active teams (8D or 5-why) to address defective quality in all products within the value stream.
- Continually improve knowledge of relevant quality/regulatory topics and changes.
- Consistently improve inspection effectiveness.
- Bachelor's degree from an accredited college or university.
- 4-7 years' experience.
- Has in-depth understanding of best practices. Has an intermediate understanding of engineering discipline Revised 09/19/2024.
- Have a solid understanding of the product strategy and can recommend solutions to critical issues.
- Requires the ability to make significant decisions directly impacting the success of one or more projects, or adjacent workgroups/functions.
- Advanced in your domain. Familiar in other areas of domain expertise within the team.
- Class III device design and development experience, such as critical care patient monitor catheter, a plus.
- Working knowledge of ISO 9001, ISO 13485; and skill in statistical methods, including ANOVA, statistical process control, sampling plans, gauge R&R, and design of experiments (DOE) is desirable.
- Communicate externally as needed, and do so in a professional manner.
- Knowledge of Microsoft Word, Excel, Outlook, Minitab, and Oracle (MRP Systems).
- Bachelor's degree from an accredited college or university.
- 4-7 years' experience.
- Typically requires travel less than 5% of the time.
- This is largely a sedentary role.
- This job operates in a professional office environment and routinely uses standard office equipment.
